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 .
The amendment filed June 10, 2026 is acknowledged. Claims 1, 3, 6, 7, 9-12, 14-17, 19, and 21-36 are pending in the application. Claims 2, 4, 5, 8, 13, 18, and 20 have been cancelled. Claims 19 and 21-34 are withdrawn from consideration.
Claim Objections
Claim 14 is objected to because of the following informalities:
In claim 14 at the end of line 1, it is suggested to insert “further” before “comprising”.
In claim 14 at line 2, it is suggested to replace “HMB” with “beta-hydroxy beta-methylbutyric acid (HMB)” after “calcium” and before “and”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 6, 7, 9-12, 14-17, and 35-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claims 1, 3, 6, 7, 9-12, 14-17, and 35-36 relate to a nutritional composition comprising proteinaceous matter derived from milk, wherein the serine content and the glycine content of the nutritional composition is at least 7 wt.% and between 5 and 30 wt.%, respectively, based on the weight of the proteinaceous matter (independent claim 1). It appears the claimed product is directed toward a product of nature. This judicial exception is not integrated into a practical application. With respect to the claimed serine content of at least 7%, page 16 (L24-25) of the specification indicates that serine in milk is typically about 5-6%. Regarding the glycine content, the specification discloses that glycine is typically present in milk in an amount of about 1-1.8% (P18, L26-27) which is slightly different than the claimed 5-30%. However, Landi et al., “Amino Acid Composition of Milk from Cow, Sheep, and Goat Raised in Ailano and Valle Agricola, Two Localities of Alto Casertano (Campania Region)” (hereinafter “Landi”) indicates that that glycine can vary from one milk product to another (Abstract; P2 and P15, Conclusion). Given this, it appears the closest product to nature would be milk protein/milk without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed quantity of glycine does not have markedly different characteristics from the naturally occurring counterpart- milk or milk protein.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 6, 7, 9, 11, 12, 17, and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Van Norren et al. US 20120252723 (hereinafter “Van Norren”).
With respect to claim 1, Van Norren relates to a nutritional composition [0038]).
Regarding the recitation of comprising, about 5 to 25.0 g per 100 kcal of proteinaceous matter, of which about 5 to 24.9 g per 100 kcal of proteinaceous matter is derived from milk; wherein the nutritional composition includes free glycine or a salt thereof and free serine or a salt thereof, the nutritional composition has a serine content of at least 7 wt.%, based on the weight of the proteinaceous matter; and the nutritional composition has a glycine content between 5 and 30 wt.%, based on the weight of the proteinaceous matter in claim 1, Van Norren teaches the nutritional composition comprises 5, 7.5, 10, and 10.1 g per at least 80 kcal of protein, and at least 50% or more of the protein is derived from whey proteins (at least 2.5, 3.75, 5, and 5.05 g per at least 80 kcal). The content of free serine or salt thereof in the nutritional composition is at least 5 weight% based on the weight of the proteinaceous matter, and the content of free glycine or salt thereof in the nutritional composition is in the range of 0.5-10 weight% based on the total proteinaceous matter (paragraphs [0038], [0078], [0081], [0088], [0106], [0131], and [0137]). The ranges of Van Norren overlap with the presently claimed ranges. 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 3, Van Norren is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of comprising: (a) about 150 to about 300 mg per 100 kcal of free serine or a salt thereof; (b) about 300 to about 600 mg per 100 kcal of free serine or a salt thereof; and/or (c) about 300 mg per 100 kcal to about 2000 mg per 100 kcal of free glycine or a salt thereof in claim 3, Van Norren teaches the nutritional composition comprises 5, 7.5, 10, and 10.1 g per at least 80 kcal of protein. The content of free serine or salt thereof in the nutritional composition is at least 5 weight% based on the weight of the proteinaceous matter (at least 0.25, 0.375, 0.5, and 0.505 g = at least 250, 375, 500, and 505 mg per at least 80 kcal of protein), and the content of free glycine or salt thereof in the nutritional composition is in the range of 0.5-10 weight% based on the total proteinaceous matter (0.025-0.5, 0.0375-0.75, 0.05-1, and 0.0505-1.01 g = 25-500, 37.5-750, 50-1000, and 50.5-1010 mg per at least 80 kcal of protein) (paragraphs [0038], [0064], [0066], [0067], [0078], [0081], [0088], [0106], [0131], and [0137]). The ranges of Van Norren overlap with the presently claimed ranges. 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 6, Van Norren is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of wherein the total content of glycine and serine is at least 1.5 g per 100 kcal in claim 6, Van Norren teaches the nutritional composition comprises 5, 7.5, 10, and 10.1 g per at least 80 kcal of protein. The serine content of the nutritional composition is at least 5 weight% based on the weight of the proteinaceous matter (at least 0.25, 0.375, 0.5, and 0.505 g per at least 80 kcal of protein), and the glycine content of the nutritional composition is in the range of 0.5-10 weight% based on the total proteinaceous matter (0.025-0.5, 0.0375-0.75, 0.05-1, and 0.0505-1.01 g per at least 80 kcal of protein) (paragraphs [0038], [0078], [0081], [0088], [0106], [0131], and [0137]). 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 7, Van Norren is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of further comprising: (a) about 400 mg per 100 kcal to about 2500 mg per 100 kcal of beta-hydroxy beta-methylbutyric acid (HMB) and/or (b) about 50 to about 150 mg of an omega-3-fatty acid selected from eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and a combination thereof in claim 7, Van Norren teaches the nutritional composition further comprises one or more of EPA or DHA (paragraphs [0061] and [0063]).
Van Norren does not expressly disclose about 50 to about 150 mg of EPA and/or DHA. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the quantity of EPA and/or DHA in the nutritional composition of Van Norren through routine experimentation with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Van Norren teaches EPA and/or DHA are beneficial anti-inflammatory components (paragraphs [0061], [0063], and [0110]), the level of anti-inflammatory effect is a matter of choice and can be adjusted as desired, and it is understood that, 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. There would have been a reasonable expectation of success. “[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) (MPEP 2144.05 II).
With respect to claim 9, Van Norren is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of comprising about 5.5 to about 20 g per 100 kcal proteinaceous matter derived from milk in claim 9, Van Norren teaches the nutritional composition comprises 5, 7.5, 10, and 10.1 g per at least 80 kcal of protein, and at least 50% or more of the protein is derived from whey proteins (at least 2.5, 3.75, 5, and 5.05 g per at least 80 kcal) (paragraphs [0038], [0078], [0081], [0131], and [0137]). The ranges of Van Norren overlap with the presently claimed range. 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 11, Van Norren is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of wherein the composition comprises 60 to 90 wt. % milk protein selected from the group consisting of casein and whey protein, 2.6-15 wt.% free serine or a salt thereof, 5-15 wt. % free glycine or a salt thereof, all based on weight of the proteinaceous matter in claim 11, Van Norren teaches the nutritional composition comprises protein and at least 50% or more of the protein is derived from whey proteins. The composition may also comprise casein. The content of free serine or salt thereof in the nutritional composition is at least 5 weight% based on the weight of the proteinaceous matter, and the content of free glycine or salt thereof in the nutritional composition is in the range of 0.5-10 weight% based on the total proteinaceous matter (paragraphs [0038], [0064], [0066], [0067], [0078], [0081], [0088], and [0106]). The ranges of Van Norren overlap with the presently claimed ranges. 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 12, Van Norren is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of comprising 3.0-10 wt. % free serine or a salt thereof in claim 12, Van Norren teaches the content of free serine or salt thereof in the nutritional composition is at least 5 weight% based on the weight of the proteinaceous matter (paragraphs [0038], [0064], [0066], [0067], [0078], [0081], and [0088]). The range of Van Norren overlaps with the presently claimed range. 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 17, Van Norren is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of wherein the nutritional composition is a powder, a tablet, a capsule, a pill or a food product selected from the group consisting of a bar, a cookie, a drink, a shake, a gel, and a yoghurt in claim 17, Van Norren teaches the nutritional composition is a food, such as a bar, drink, gel, or yoghurt (paragraphs [0122] and [0123]).
With respect to claim 35, Van Norren is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of comprising 8.0-12 wt.% free glycine or a salt thereof in claim 35, Van Norren teaches the content of free glycine or salt thereof in the nutritional composition is in the range of 0.5-10 weight% (paragraphs [0038], [0064], [0066], [0067], [0078], [0081], and [0106]). The range of Van Norren overlaps with the presently claimed range. 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 36, Van Norren is relied upon for the teaching of the composition of claim 12 as addressed above.
Regarding the recitation of comprising 8.0-12 wt.% free glycine or a salt thereof in claim 36, Van Norren teaches the content of free glycine or salt thereof in the nutritional composition is in the range of 0.5-10 weight% (paragraphs [0038], [0064], [0066], [0067], [0078], [0081], and [0106]). The range of Van Norren overlaps with the presently claimed range. 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).
Claims 10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Van Norren et al. US 20120252723 (hereinafter “Van Norren”) as applied to claims 1, 7, and 11 above, and in further view of Nissen et al. US 6031000 (hereinafter “Nissen”) and Anthony et al. US 20070166411 (hereinafter “Anthony”).
With respect to claim 10, Van Norren is relied upon for the teaching of the composition of claims 1 and 7 as addressed above.
Regarding the recitation of comprising about 7 to about 15 g per 100 kcal of proteinaceous matter, of which about 5 to about 10 g per 100 kcal of proteinaceous matter derived from milk; about 750 to about 1250 mg per 100 kcal of free glycine or a salt thereof; and about 200 to about 300 mg per 100 kcal of free serine or a salt thereof; about 600 to about 900 mg per 100 kcal of free beta-hydroxy beta-methylbutyric acid (HMB); about 75 to about 125 mg per 100 kcal of an omega-3-fatty acid selected from eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and a combination thereof; and further comprising: about 75 to about 125 mg per 100 kcal of choline; and carbohydrates and/or fat in claim 10, Van Norren teaches the nutritional composition comprises carbohydrates, fat, and 5, 7.5, 10, and 10.1 g per at least 80 kcal of protein, and at least 50% or more of the protein is derived from whey proteins (at least 2.5, 3.75, 5, and 5.05 g per at least 80 kcal). The content of free serine or salt thereof in the nutritional composition is at least 5 weight% based on the weight of the proteinaceous matter (at least 0.25, 0.375, 0.5, and 0.505 g = at least 250, 375, 500, and 505 mg per at least 80 kcal of protein), and the content of free glycine or salt thereof in the nutritional composition is in the range of 0.5-10 weight% based on the total proteinaceous matter (0.025-0.5, 0.0375-0.75, 0.05-1, and 0.0505-1.01 g = 25-500, 37.5-750, 50-1000, and 50.5-1010 mg per at least 80 kcal of protein) (paragraphs [0038], [0064], [0066], [0067], [0078], [0081], [0088], [0106], [0131], and [0137]). The ranges of Van Norren overlap with the presently claimed ranges. 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).
However, Van Norren does not expressly disclose the composition comprises HMB.
Nissen relates to a composition comprising HMB and at least one amino acid, such as glycine. HMB may be in its free form in the amount of about 0.5 g to about 30 g (about 500-about 30,000 mg) (C2, L10-11 and 49-57; and C3, L48-52 and 64-66).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Nissen, to select HMB based in its suitability for its intended purpose in the composition of Van Norren with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Van Norren and Nissen similarly teach compositions comprising amino acids, Nissen teaches HMB is useful in a variety of applications, is effective in enhancing the immune response of mammals, and decreases the serum-level of triglycerides and serum viral load of animals (C1, L16-17 and 25-26; and C2, L35-37), Van Norren teaches including additional ingredients for nutritional compositions (paragraph [0118]), and said combination would amount to the use of a known element for its 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).
Van Norren also teaches the nutritional composition further comprises one or more of EPA or DHA (paragraphs [0061] and [0063]).
However, Van Norren does not expressly disclose about 75 to about 125 mg per 100 kcal of EPA and/or DHA and the composition comprises about 75 to about 125 mg per 100 kcal of choline.
Anthony relates to a nutritional composition. The composition comprises a protein component, such as milk protein and free amino acids (glycine and serine), carbohydrate, fat, at least one source of omega-3-fatty acid (DHA) in the range of about 1 mg to about 200 mg per 100 kcal, and choline in a range of about 0.1 mg to about 500 mg per 100 kcal (paragraphs [0021], [0042], [0045], [0049], [0060], [0074], and [0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Anthony, to select choline based in its suitability for its intended purpose in the composition of Van Norren as well as to select any portions of the disclosed ranges, including the instantly claimed ranges of EPA and/or DHA and choline, from the ranges disclosed in the prior art with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Van Norren and Anthony similarly teach nutritional compositions comprising amino acids, milk protein, carbohydrate, fat, and omega-3-fatty acids, Anthony teaches the nutritional supplement provides health benefits and/or prevents adverse health consequences (paragraph [0003]), Van Norren teaches including additional ingredients for nutritional compositions and EPA and/or DHA are beneficial anti-inflammatory components (paragraphs [0061], [0063], [0110], and [0118]), and said combination would amount to the use of a known element for its 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). "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 14, modified Van Norren is relied upon for the teaching of the composition of claim 11 as addressed above.
Regarding the recitation of comprising 500 to 1500 mg/100 kcal calcium HMB and about 30 mg to about 150 mg/100 kcal choline in claim 14, Van Norren does not expressly disclose the composition comprises calcium HMB.
Nissen relates to a composition comprising HMB and at least one amino acid, such as glycine. HMB may be in the form of calcium HMB and present in the amount of about 0.5 g to about 30 g (about 500-about 30,000 mg) (C2, L10-11 and 49-57; and C3, L1-2, 48-52, and 64-66).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Nissen, to select calcium HMB based in its suitability for its intended purpose in the composition of Van Norren with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Van Norren and Nissen similarly teach compositions comprising amino acids, Nissen teaches HMB is useful in a variety of applications, is effective in enhancing the immune response of mammals, and decreases the serum-level of triglycerides and serum viral load of animals (C1, L16-17 and 25-26; and C2, L35-37), Van Norren teaches including additional ingredients for nutritional compositions (paragraph [0118]), and said combination would amount to the use of a known element for its 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).
Van Norren also does not expressly disclose the composition comprises about 30 to about 150 mg per 100 kcal of choline.
Anthony relates to a nutritional composition. The composition comprises a protein component, such as milk protein and free amino acids (glycine and serine), and choline in a range of about 0.1 mg to about 500 mg per 100 kcal (paragraphs [0021], [0042], [0045], [0060], and [0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Anthony, to select choline based in its suitability for its intended purpose in the composition of Van Norren as well as to select any portions of the disclosed range, including the instantly claimed range of choline, from the range disclosed in the prior art with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Van Norren and Anthony similarly teach nutritional compositions comprising amino acids and milk proteins, Anthony teaches the nutritional supplement provides health benefits and/or prevents adverse health consequences (paragraph [0003]), Van Norren teaches including additional ingredients for nutritional compositions (paragraph [0118]), and said combination would amount to the use of a known element for its 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). "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.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Van Norren et al. US 20120252723 (hereinafter “Van Norren”) as applied to claim 1 above, and in further view of Anthony et al. US 20070166411 (hereinafter “Anthony”).
With respect to claim 15, Van Norren is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of wherein the nutritional composition comprises milk fat in claim 15, Van Norren teaches the composition comprises fat (paragraph [0125]).
However, Van Norren does not expressly disclose the fat is milk fat.
Anthony relates to a nutritional composition. The composition comprises a protein component, such as milk protein and free amino acids (glycine and serine), and fat such as milk fat (paragraphs [0021], [0042], [0045], and [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Anthony, to select milk fat based in its suitability for its intended purpose in the composition of Van Norren with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Van Norren and Anthony similarly teach nutritional compositions comprising amino acids, milk protein, and fat, Anthony teaches the nutritional supplement provides health benefits and/or prevents adverse health consequences (paragraph [0003]), Van Norren teaches including additional ingredients for nutritional compositions and any food-grade fat composition may be used (paragraphs [0115] and [0118]), and said combination would amount to the use of a known element for its 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).
With respect to claim 16, Van Norren is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of packaged as a serving of about 80 to about 400 kcal in claim 16, Van Norren teaches servings of the nutritional composition of least 80 kcal (paragraphs [0118], [0131], and [0137]). 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).
However, Van Norren does not expressly disclose the nutritional composition is packaged.
Anthony relates to a nutritional composition. The composition comprises a protein component, such as milk protein and free amino acids (glycine and serine), and the composition may be packaged (paragraphs [0021], [0042], [0045], and [0123]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Anthony, to select a package for the nutritional composition of Van Norren based in its suitability for its 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 Van Norren and Anthony similarly teach nutritional compositions comprising amino acids and milk protein, manufacturing of a nutritional composition commonly involves packaging of the composition, packaged nutritional compositions were well known in the art before the effective filing date of the claimed invention as shown in Anthony, and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. 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).
Response to Arguments
Applicant’s remarks filed June 10, 2026 are acknowledged.
Due to the amendments to the claims, the claim objections and the 35 USC 112 rejection in the previous Office Action have been withdrawn (P7-P8).
Applicant’s arguments have been considered, but they are unpersuasive.
Applicant argues the claimed nutritional composition has a serine content of at least 7 wt.% based on the weight of the proteinaceous matter and renders the potential overlap argument moot. The argument regarding the minimal glycine content of 5% is without any merit. The minimal content in a composition according to claim 1 is more than twice the maximum amount typically present in milk. To consider such a difference “slightly” different is without merit. The Examiner’s reference to Landi et al does not change the fact that the glycine content in the claimed composition is substantially higher than typically in milk. Landi does not give any reasonable clue that it would be even possible that milk exists with a glycine content close to at least 5 wt.% of total proteinaceous matter. It is apparent that the glycine contents in Landi are not within the range mentioned in the present application. Thus, the information provided by the Examiner confirms the position that the amount of glycine in the instantly claimed composition is substantially higher than a natural product. Also on the basis of Landi it is not plausible at all that milk might contain more than twice the amount of glycine than what is currently known. Therefore, claim 1, as amended, is distinguished over a natural product (milk) by its higher serine content and its higher glycine content. The application provides a practical application for a composition according to claim 1 (P8-P10).
Examiner disagrees and maintains that the claimed invention is directed to a product of nature without significantly more. The present invention relates to a composition comprising proteinaceous matter derived from milk, serine, and glycine. It appears the claimed composition is directed toward a product of nature without significantly more since it is well understood that milk and milk protein comprises milk derived proteinaceous matter, serine, and glycine. Page 16 (L24-25) of the specification indicates that serine in milk is typically about 5-6% which is very close to the claimed content of serine of at least 7 wt. %. While the specification discloses that glycine is typically present in milk in an amount of about 1-1.8% (P18, L26-27) which is slightly different than the claimed 5-30%, the specification also discloses nutritional composition usually has a glycine content of 2 wt.% or more (P17, L27-28) which is very close to the glycine content in milk. Additionally, Landi indicates that glycine can vary from one milk product to another (Abstract; P2 and P15, Conclusion). Although Applicant argues that the serine contents in Landi are not within the presently claimed range, it is noted that the serine contents in Landi are based on the total amino acid content as opposed to the weight of the proteinaceous matter as claimed. Further, the instant specification discloses serine and glycine may be provided by milk protein (P16, L20-23; and P18, L22-25). Thus, it appears the closest product to nature would be milk protein or milk without significantly more, and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Applicant argues while glycine is listed as a potential component in the combination of amino acids, there is no teaching or motivation to add glycine to the combination of (i) serine, (ii) cysteine, (iii) arginine, and (iv) at least one branched amino acid for use in the treatment of inflammation or infection. There is no clear showing in Van Norren to arrive at all of the requirements of claim 1. There are no specific teachings in Van Norren to combine both glycine and serine in the instantly claimed ranges and to achieve the ranges bv partially including free amino acid and not, e.g., a protein with high glycine content, such as collagen. Further, Example 1, which is directed to a nutritional composition for use fails to refer to including free amino acids or salts thereof and the amounts for both glycine (1.7-2.1%) and serine (5.1-6.3%) are significantly lower than the instantly claimed ranges. There are no further compositions exemplified with higher ranges of glycine or serine or compositions comprising free amino acids or salts thereof. Thus, Van Norren fails to provide a person skilled in the art with a reasonable expectation of success in arriving at the instantly claimed compositions. Van Norren fails to disclose or suggest each and every element of the instantly claimed nutritional composition, and further fails to provide one of skill in the art with an expectation of success in arriving at a nutritional composition comprising serine and glycine, wherein the serine and glycine can be free serine or a salt thereof or free glycine or a salt thereof. The number of choices possible from the options provided in the prior art is unlimited, and the prior art failed to provide a finite number of choices even for the hypothetical unclaimed invention (i.e., by providing any working examples demonstrating nutritional compositions comprising serine and glycine, including free serine and glycine, in the instantly claimed ranges) to guide one of ordinary skill in the art to arrive at the instantly claimed nutritional compositions with a reasonable expectation of success without undue experimentation. Accordingly, the instantly claimed nutritional compositions are not prima facie obvious based on Van Norren, at least because the cited references in combination do not provide specific guidance for one to pick and choose each of the elements of the instantly claimed nutritional compositions and combine them together in the manner recited in the instant claims (P10-P13).
Examiner disagrees. The claimed invention is obvious in view of Van Norren, and a prima facie case of obviousness has adequately been established. Van Norren is not limited to its examples since the reference also teaches the content of free serine or salt thereof in the nutritional composition is at least 5 weight% based on the weight of the proteinaceous matter, and the content of free glycine or salt thereof in the nutritional composition is in the range of 0.5-10 weight% based on the total proteinaceous matter (paragraphs [0038], [0088], and [0106]). 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). Applicant is reminded that "[t]he use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). “Applicant must look to the whole reference for what it teaches. Applicant cannot merely rely on the examples and argue that the reference did not teach others.” In re Courtright, 377 F.2d 647, 153 USPQ 735,739 (CCPA 1967).
Applicant argues Nissen and Anthony fail to make up for the deficiencies of Van Norren with respect to claims 1 and 7. Given this, Nissen and Anthony, alone and in combination, also fail to provide a person skilled in the art with a reasonable expectation of success (P13-P14).
Examiner disagrees. As addressed above, Van Norren teaches the invention in independent claim 1 and claim 7. Secondary references Nissen and Anthony are relied upon for the teaching of dependent claims 10 and 14-16. Applicant is reminded that it is not necessary for the secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981).
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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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
/T.L.M/Examiner, Art Unit 1793
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