DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The amendment filed July 23, 2025 is acknowledged. Claims 1-20 are pending in the application.
Claim Objections
Claim 18 is objected to because of the following informalities:
In claim 18 at line 3, it is suggested to amend “phosphorous” to “phosphorus” to correct the typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16 and 18-20 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.
Newly added claim 16 recites “at least 98.1% digestible” at line 2. While the instant specification provides support for 98.1% digestible, the originally filed application fails to provide support for “at least”. See paragraph [0078] and P31, Table 3.
Newly added claim 18 recites “a magnesium content of at least 1,600ppm, a phosphorous content of at least 6,400ppm; an iron content of at least 130 ppm” at lines 2-4. While the instant specification provides support for 1,600ppm magnesium, 6,400ppm of phosphorous, and 130 ppm iron, the originally filed application fails to provide support for “at least” for all of these values. See P25, Table 1.
Newly added claim 19 recites “a sodium content of at least 2,000ppm, a potassium content of at least 5,500ppm; a calcium content of at least 22,000 ppm” at lines 2-4. While the instant specification provides support for 2,000ppm sodium, 5,500ppm of potassium, and 22,000 ppm calcium, the originally filed application fails to provide support for “at least” for all of these values. See P25-P26, Table 1.
Newly added claim 20 recites “a sodium content of at least 2,000ppm, a potassium content of at least 5,500ppm; a tryptophan content of at least 1.06% of the fish derived protein powder product” at lines 2-4. While the instant specification provides support for 2,000ppm sodium, 5,500ppm of potassium, and 1.06% tryptophan, the originally filed application fails to provide support for “at least” for all of these values. See P26, Table 1 and P29, Table 2.
Accordingly, there is no indication that applicant had possession of the presently claimed invention at the time of the filing the instant application.
With respect to changing numerical range limitations, the analysis must take into account which ranges one skilled in the art would consider inherently supported by the discussion in the original disclosure. In the decision in In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), the ranges described in the original specification included a range of "25%- 60%" and specific examples of "36%" and "50%." A corresponding new claim limitation to "at least 35%" did not meet the description requirement because the phrase "at least" had no upper limit and caused the claim to read literally on embodiments outside the "25% to 60%" range. See MPEP 2163.05.
The failure to meet the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, commonly arises when the claims are changed after filing to either broaden or narrow the breadth of the claim limitations, or to alter a numerical range limitation or to use claim language which is not synonymous with the terminology used in the original disclosure. To comply with the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para. 1, or to be entitled to an earlier priority date or filing date under 35 U.S.C. 119, 120, or 365(c), each claim limitation must be expressly, implicitly, or inherently supported in the originally filed disclosure. SEE MPEP 2163.05.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 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.
Claims 1, 2, and 4-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lu et al. CN 1157694 (hereinafter “Lu”) (refer to the corresponding machine translation) in view of Kosbab US 20010031744 (hereinafter “Kosbab”) and Manning et al. US 20060088574 (hereinafter “Manning”).
With respect to claim 1, Lu teaches a fish derived protein powder product (paragraph [0001]).
Regarding the recitation of “wherein a serving of said fish derived protein powder product is 35 grams” in claim 1, it is noted that it is not readily apparent if the wherein clause is intended to further limit the claim. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. For the purpose of the examination, and consistent with the specification, the recitation of “wherein a serving of said fish derived protein powder product is 35 grams” in claim 1 is used as the basis for calculating the weight percent of the listed ingredients.
Regarding the limitation of comprising a fish derived protein content of 85% to 90% by weight of the fish derived protein powder product as recited in claim 1, Lu teaches a fish protein powder comprising a fish derived protein content of at least 80% of the protein powder which encompasses the presently claimed invention (paragraphs [0001], [0006], and [0007]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding the limitation of .035% by weight of the fish derived protein powder product of lithium, .035% by weight of the fish derived protein powder product of boron, .035% by weight of the fish derived protein powder product of cobalt as recited in claim 1 (or 12.25 mg = 0.01225 g of lithium, boron and cobalt calculated from [0.035 / 100] X 35 grams per serving), Lu does not expressly disclose this limitation.
Kosbab teaches a nutrient composition. The composition may include minor amounts of minerals, such as 1 mcg to 50 mg lithium, 0 mcg to 100 mg boron, and 10 mcg to 200 mg cobalt, and may be in powdered form (paragraphs [0009], [0373], [0420], [0432], and [0435]-[0436]).
It would have been obvious to one of ordinary skill in the art at the time of the invention, given the teachings of Kosbab, to select lithium, boron, and cobalt in the product of Lu based in their suitability for their intended purpose with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Kosbab and Lu similarly teach nutritional compositions, Kosbab teaches the minerals may have beneficial or nutritional value for an individual (paragraph [0420]), Lu teaches the nutritional product comprises various minerals and trace elements, has high nutritional value, and has a variety of uses (paragraphs [0004] and [0006]), and said combination would amount to the use of known elements for their intended use in a known environment to accomplish entirely expected results. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
Regarding the limitation of comprising a transfatty acid content of 0.02% by weight of the fish derived protein powder product as recited in claim 1, Lu does not expressly disclose the transfatty acid content of the powder.
Manning teaches nutritional supplements comprising fish protein. The nutritional supplement may be in the form of a powder. The nutritional supplement contains an amount of trans fat that provides about 10% or less of daily energy requirements. The supplement is low in trans fatty acids or preferably contains no trans fatty acids (Abstract; paragraphs [0429]-[0431], [0458], [0483], [0484], and [0556]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to select any portions of the disclosed range, including the instantly claimed range of a transfatty acid content of 0.02%, from the ranges disclosed in the prior art reference with the expectation of successfully preparing a functional protein powder product. One of ordinary skill in the art would have been motivated to do so because Lu teaches the fish protein powder contains less than or equal to 2.0% fat, has high nutritional value, and has a variety of uses (paragraphs [0002], [0006], and [0007]) and Manning teaches the nutritional supplement is low in trans fatty acids and preferably contains no trans fatty acids which is interpreted as a fish protein powder with a trans fatty acid content of zero to slightly above zero, the amount of transfatty acid will vary depending upon the type of oil and/or fat that is in the nutritional supplement, and the supplement provides one or more nutritional, medical, or other health benefits (paragraphs [0153], [0429], [0431], [0433], and [0458]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
With respect to claim 2, modified Lu teaches the fish derived protein powder product of claim 1 which has been addressed above.
Regarding the limitation of further comprising 0.497 grams of crude fat as recited in claim 2 (or 1.42% calculated from [0.497 g of crude fat / 35 g serving of protein powder product] X 100), modified Lu teaches this limitation since Lu teaches the fish protein powder contains less than or equal to 2.0% fat (paragraph [0007]) and encompasses the presently claimed quantity. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 4, modified Lu teaches the fish derived protein powder product of claim 1 which has been addressed above.
Regarding the limitation of further comprising 1.6 grams of aspartic acid as recited in claim 4 (or 4.57% calculated from [1.6 g of aspartic acid / 35 g serving of protein powder product] X 100), modified Lu teaches this limitation since Lu teaches the fish protein powder contains less than or equal to 10.0% aspartic acid (paragraph [0007]) and encompasses the claimed quantity. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 5, modified Lu teaches the fish derived protein powder product of claim 1 which has been addressed above.
Regarding the limitation of wherein said fish derived protein powder product is generated by sanitizing raw material from aquatic animals mixture with ozone (step a); combining the raw material with a solvent to create a mixture (step b); baking the combined mixture for a first time period (step c); separating, with a filter, liquid from the combined mixture that was baked for the first time period (step d); baking the combined mixture without the separated liquid for a second time period (step e); separating, with a filter, liquid from the combined mixture that was baked for the second time period (step f); curing the combined mixture (step g); and processing the cured mixture to produce protein powder (step h) as recited in claim 5, this recitation relates to process limitations for preparing the protein powder product. The steps of sanitizing, combining, baking, separating, baking, curing, and processing of claim 5 do not appear to impart distinctive structural characteristics to the final protein powder product. “[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, 227 USPQ 964,966).
As shown above, modified Lu teaches the fish derived protein powder product of claim 1. Additionally, Lu teaches preparing the fish protein powder by washing the fish material, combining the material with solvent, controlling the temperature of the material, filtering, raising the temperature, filtering, concentrating, and processing the concentrated product to produce the fish protein powder (paragraphs [0005] and [0011]-[0014]), and the steps as recited in the claims do not appear to produce a materially different product from the prior art. Therefore, since the fish derived protein powder as recited in claim 1 is the same as the fish protein powder product taught by modified Lu, as set forth above, claim 5 is unpatentable even though the fish protein product of modified Lu was made by a different process. Once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), MPEP 2113).
With respect to claims 6-14, modified Lu teaches the fish derived protein powder product of claim 5 which has been addressed above.
Regarding the limitations of wherein said generation further comprises baking the combined mixture without the separated liquid for a third time period and separating liquid from the combined mixture that was baked for the third time period as recited in claim 6, wherein said generation further comprises filtering amine from the liquid separated by the filter in step d as recited in claim 7, wherein said generation further comprises distilling the liquid in step d; and filtering at least a portion of the distilled liquid to produce fish oil as recited in claim 8, wherein said generation further comprises distilling the liquid in step d; filtering at least a portion of the distilled liquid to produce water; and purifying the water as recited in claim 9, further comprising adding a second solvent to the combined mixture prior to baking for the first time period as recited in claim 10, wherein said generation further comprises filtering amine from the liquid separated by the filter in step e as recited in claim 11, wherein said generation further comprises distilling the liquid in step e and filtering at least a portion of the distilled liquid to produce fish oil as recited in claim 12, wherein said generation further comprises distilling the liquid in step e, filtering at least a portion of the distilled liquid to produce water, and purifying the water as recited in claim 13, and wherein said generation further comprises adding a second solvent to the combined mixture prior to baking for the second time period as recited in claim 14, these recitations relate to process limitations for preparing the protein powder product. The steps of baking, separating, filtering, distilling, purifying, and adding as recited in claims 6-14 do not appear to impart distinctive structural characteristics to the final protein powder product. “[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, 227 USPQ 964,966).
As shown above, modified Lu teaches the protein powder product of claims 1 and 5. Additionally, Lu teaches preparing the fish protein powder by washing the fish material, combining the material with solvent, controlling the temperature of the material, filtering, raising the temperature, filtering, concentrating, and processing the concentrated product to produce the fish protein powder (paragraphs [0005] and [0011]-[0014]), and the steps as recited in the claims do not appear to produce a materially different product from the prior art. Therefore, since the fish derived protein powder as recited in claims 1 and 5 are the same as the fish protein powder product taught by modified Lu, as set forth above, claims 6-14 are unpatentable even though the fish protein product of modified Lu was made by a different process. Once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), MPEP 2113).
With respect to claim 15, modified Lu teaches the fish derived protein powder product of claim 1 which has been addressed above.
Regarding the limitation of wherein a cholesterol content is 0.01% by weight of the fish derived protein powder product as recited in claim 15, Lu does not expressly disclose the cholesterol content of the powder.
Manning teaches nutritional supplements comprising fish protein. The nutritional supplement may be in the form of a powder. The nutritional supplement is low in cholesterol or has zero cholesterol (Abstract; paragraphs [0429], [0431], [0483], [0484], and [0556]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to select any portions of the disclosed range, including the instantly claimed range of a cholesterol content of 0.01%, from the ranges disclosed in the prior art reference with the expectation of successfully preparing a functional protein powder product. One of ordinary skill in the art would have been motivated to do so because Lu teaches the fish protein powder contains less than or equal to 2.0% fat, has high nutritional value, and has a variety of uses (paragraphs [0002], [0006], and [0007]) and Manning teaches the nutritional supplement is low in cholesterol or has zero cholesterol which is interpreted as a fish protein powder with a cholesterol content of zero to slightly above zero, the amount will vary depending upon the type of oil and/or fat that is in the nutritional supplement, and the supplement provides one or more nutritional, medical, or other health benefits (paragraphs [0153], [0429], [0431], and [0433]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
With respect to claims 16 and 17, modified Lu teaches the fish derived protein powder product of claim 1 which has been addressed above.
Regarding the limitations of wherein the fish derived protein powder product is non-hydroscopic and at least 98.1% digestible as recited in claim 16 and wherein the fish derived protein powder product is non-hydroscopic as recited in claim 17, it is noted that these recitations relate to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04.
Absent any clear and convincing evidence to the contrary, the product would intrinsically contain these claimed features since modified Lu teaches a product that is substantially similar to the presently claimed product as addressed above in claim 1 and Lu teaches the powdered product is easily soluble in water, has good flavor, and comprises a fish derived protein content of at least 80% of the protein powder (paragraph [0006]). Additionally, the functional language is not considered to confer patentability to the claims.
With respect to claim 18, modified Lu teaches the fish derived protein powder product of claim 1 which has been addressed above.
Regarding the limitation of further comprising a magnesium content of at least 1,600ppm (or 0.16%), a phosphorous content of at least 6,400ppm (or 0.64%); an iron content of at least 130 ppm (or 0.013%) as recited in claim 18, Lu does not expressly disclose this limitation.
Manning teaches nutritional supplements comprising fish protein. The nutritional supplement may be in the form of a powder. The nutritional supplement preferably contains 0-600 mg magnesium, 0-2 g phosphorous, and 0-100 mg iron per 60 g of the nutritional supplement (0-1% magnesium, 0-3.3% phosphorus, and 0-0.17% iron in the nutritional supplement) (Abstract; paragraphs [0332], [0483], [0484], and [0556]; and P24, Table).
It would have been obvious to one of ordinary skill in the art at the time of the invention, given the teachings of Manning, to select magnesium, phosphorous, and iron and their respective quantities in the product of Lu based in their suitability for their intended purpose with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Manning and Lu similarly teach nutritional compositions comprising fish protein, Manning teaches the supplement provides one or more nutritional, medical, or other health benefits (paragraph [0153]), Lu teaches the nutritional product comprises various minerals and trace elements, has high nutritional value, and has a variety of uses (paragraphs [0004] and [0006]), and said combination would amount to the use of known elements for their intended use in a known environment to accomplish entirely expected results. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
One of ordinary skill in the art would have been motivated to do so because Lu teaches the fish protein powder contains less than or equal to 2.0% fat, has high nutritional value, and has a variety of uses (paragraphs [0002], [0006], and [0007]) and Manning teaches the nutritional supplement is low in trans fatty acids and preferably contains no trans fatty acids which is interpreted as a fish protein powder with a trans fatty acid content of zero to slightly above zero, the amount of transfatty acid will vary depending upon the type of oil and/or fat that is in the nutritional supplement, and the supplement provides one or more nutritional, medical, or other health benefits (paragraphs [0153], [0429], [0431], [0433], and [0458]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
With respect to claim 19, modified Lu teaches the fish derived protein powder product of claim 18 which has been addressed above.
Regarding the limitation of further comprising a sodium content of at least 2,000ppm (or 0.20%), a potassium content of at least 5,500ppm (or 0.55%); a calcium content of at least 22,000 ppm (or 2.2%) as recited in claim 19, Lu does not expressly disclose this limitation.
Manning teaches nutritional supplements comprising fish protein. The nutritional supplement may be in the form of a powder. The nutritional supplement preferably contains 0-2,400 mg sodium, 0-4,000 mg potassium, and 0-3 g calcium per 60 g of the nutritional supplement (0-4% sodium, 0-6.7% potassium, and 0-5% calcium in the nutritional supplement) (Abstract; paragraphs [0292], [0293], [0332], [0483], [0484], and [0556]; and P24, Table).
It would have been obvious to one of ordinary skill in the art at the time of the invention, given the teachings of Manning, to select sodium, potassium, and calcium and their respective quantities in the product of Lu based in their suitability for their intended purpose with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Manning and Lu similarly teach nutritional compositions comprising fish protein, Manning teaches the supplement provides one or more nutritional, medical, or other health benefits (paragraph [0153]), Lu teaches the nutritional product comprises various minerals and trace elements, has high nutritional value, and has a variety of uses (paragraphs [0004] and [0006]), and said combination would amount to the use of known elements for their intended use in a known environment to accomplish entirely expected results. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
Claims 3 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lu et al. CN 1157694 (hereinafter “Lu”) (refer to the corresponding machine translation) in view of in view of Kosbab US 20010031744 (hereinafter “Kosbab”) and Manning et al. US 20060088574 (hereinafter “Manning”) as applied to claims 1, 18, and 19 above, and in further view of Delahanty, Jr. US 20050129835 (hereinafter “Delahanty”).
With respect to claim 3, modified Lu teaches the fish derived protein powder product of claim 1 which has been addressed above.
Regarding the limitation of further comprising 0.371 grams of tryptophan as recited in claim 3 (or 1.06% calculated from [0.371 g of crude fat / 35 g serving of protein powder product] X 100), Lu does not expressly disclose the claimed quantity of tryptophan.
Delahanty teaches a fish derived protein powder product. The protein powder includes an amino acid profile with between about 0.5% and about 3.0% by weight of tryptophan (paragraphs [0013], [0018], [0025], [0026], [0049]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to select any portions of the disclosed range, including the instantly claimed range of 0.371 grams of tryptophan (1.06% tryptophan), from the range disclosed in the prior art reference with the expectation of successfully preparing a functional protein powder product. One of ordinary skill in the art would have been motivated to do so because Delahanty and Lu similarly teach fish protein powder products, Lu teaches the fish protein powder comprises amino acids and has a variety of uses (paragraphs [0002] and [0006]), and Delahanty teaches the protein compositions can be optimally tailored to the user with acceptable and satisfactory quantities of constituents (paragraphs [0013], [0017], [0026], [0048], [0049], and [0051]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
With respect to claim 20, modified Lu teaches the fish derived protein powder product of claims 18 and 19 which have been addressed above.
Regarding the limitation of further comprising a sodium content of at least 2,000ppm (or 0.20%), a potassium content of at least 5,500ppm (or 0.55%) as recited in claim 20, Lu as modified by Manning teaches this limitation since Manning is relied upon for the teaching of the sodium content and the potassium content as addressed above in claim 19, and Manning teaches the nutritional supplement preferably contains 0-2,400 mg sodium and 0-4,000 mg potassium per 60 g of the nutritional supplement (0-4% sodium and 0-6.7% potassium in the nutritional supplement) (Abstract; paragraphs [0292], [0293], [0332], [0483], [0484], and [0556]; and P24, Table).
Regarding the limitation of further comprising a tryptophan content of at least 1.06% of the fish derived protein powder product as recited in claim 20, Lu does not expressly disclose the claimed quantity of tryptophan.
Delahanty teaches a fish derived protein powder product. The protein powder includes an amino acid profile with between about 0.5% and about 3.0% by weight of tryptophan (paragraphs [0013], [0018], [0025], [0026], [0049]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to select any portions of the disclosed range, including the instantly claimed range of tryptophan, from the range disclosed in the prior art reference with the expectation of successfully preparing a functional protein powder product. One of ordinary skill in the art would have been motivated to do so because Delahanty and Lu similarly teach fish protein powder products, Lu teaches the fish protein powder comprises amino acids and has a variety of uses (paragraphs [0002] and [0006]), and Delahanty teaches the protein compositions can be optimally tailored to the user with acceptable and satisfactory quantities of constituents (paragraphs [0013], [0017], [0026], [0048], [0049], and [0051]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Response to Arguments
Applicant’s remarks filed July 23, 2025 are acknowledged.
Due to the amendments to the claims, the claim objections, the 35 USC 112 rejection, the 35 USC 103 rejection of claims 1, 2, and 4-15 over Lu in view of Manning and claim 3 over Lu in view of Manning and Delahanty, Jr. in the previous Office Action have been withdrawn (P5).. However, the 35 USC 112 rejection above is necessitated by the amendments to the claims. Additionally, upon further searching and consideration, a new ground of rejection has been made in view of Lu, Kosbab, and Manning which teaches a fish protein powder product substantially similar to that as presently claimed.
Applicant’s arguments have been fully considered, but they are unpersuasive.
Applicant argues Manning does not disclose any range of transfatty acid relative to the sample mass. Manning discloses a percentage of “daily energy requirements” though Applicant asserts that Manning does not disclose how one would determine what “daily energy requirements” means. Manning does not disclose any objective measure to help one of ordinary skill in the art to determine how to assess “daily energy requirements” and whether such assessment is based on data from a specific individual or some unarticulated population of individuals. Stated another way, Manning provides no metric as to what, quantitively, “daily energy requirements” means or could possibly mean. Applicant asserts that 10% of an undefined amount is undefined. Thus, Applicant asserts that Manning’s recitation of “10%” of an unknown, and indeed unknowable, quantity does not meaningfully inform one of skill in the art relative to the transfat content of Manning’s formulations. In this manner, Applicant asserts that Manning does not disclose a “range taught in the prior art” since Manning merely teaches 10% of an undefined amount, which is unknowable. Accordingly, Manning fails to disclose or contemplate any range with which to be compared to the claimed invention (P5-P7).
Examiner disagrees. Lu as modified by Manning teaches the claimed trans fatty acid content. As addressed above, Manning teaches nutritional supplements comprising fish protein. The nutritional supplement may be in the form of a powder. The nutritional supplement contains an amount of trans fat that provides about 10% or less of daily energy requirements. The supplement is low in trans fatty acids or preferably contains no trans fatty acids (Abstract; paragraphs [0429]-[0431], [0458], [0483], [0484], and [0556]). Manning also teaches the amount of trans fatty acids vary depending upon the type of oil and/or fat that is in the nutritional supplement, and the supplement provides one or more nutritional, medical, or other health benefits (paragraphs [0153], [0429], and [0433]). From the teachings of Manning, which is interpreted as a fish protein powder with a trans fatty acid content of zero to slightly above zero, and the disclosure of Lu which teaches the fish protein powder contains less than or equal to 2.0% fat (paragraph [0007]), one of ordinary skill in the art would have been motivated to select any portion of the range taught in the prior art, including the instantly claimed range of a transfatty acid content of 0.02%, with the expectation of successfully preparing a functional protein powder product. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Applicant argues it is at least ambiguous as to whether Lu discloses “digestible protein” or merely amino acids (P7).
Examiner disagrees. It is noted that the recitation of “at least 98.1% digestible” in claim 16 relates to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04.
Absent any clear and convincing evidence to the contrary, the product would intrinsically contain this claimed feature since modified Lu teaches a product that is substantially similar to the presently claimed product as addressed above in claim 1 and Lu teaches the powdered product has good flavor and comprises a fish derived protein content of at least 80% of the protein powder (paragraph [0006]). Additionally, the functional language is not considered to confer patentability to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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