DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Request for Continued Examination (RCE under 37 CFR 1.114), the Response, and Amendment filed 12/18/2025 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment: the objection to claim 1 has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1, 5-17
Withdrawn claims: None
Previously cancelled claims: 2-4, 18-22
Newly cancelled claims: None
Amended claims: 1, 17
New claims: None
Claims currently under consideration: 1, 5-17
Currently rejected claims: 1, 5-17
Allowed claims: None
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 has been entered.
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.
Claims 1 and 5-17 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 17 recite that the liver extract retains “fat-soluble repair enzymes”; and that the dietary supplement comprises an alpha-ketoglutarate (AKG) hydroxylation agent “in an amount of at least 10 mg”. Neither the previous versions of the claims nor the present specification disclose “fat-soluble repair enzymes” or enzymes of any kind at all. Therefore, the required inclusion of “fat-soluble repair enzymes” constitutes new matter. Furthermore, the previous versions of the claims and the present specification also do not disclose a content of AKG of greater than 200 mg (specification [0013]). The now-recited amount of “at least 10 mg” includes amounts greater than 200 mg. As such, the amount of “at least 10 mg” is not supported by the previous versions of the claims or the present specification so that the required inclusion of “at least 10 mg” of AKG constitutes new matter.
Claims 5-16 are rejected by reason of dependency from claim 1.
The present claims now have an effective filing date of 12/18/2025 (i.e., the date of the entry of the new matter) instead of the effective filing date of 10/19/2021 (i.e.. the date of filing of the present application).
Claims 1 and 5-17 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In claims 1 and 17, the broadest interpretation of the product is a dietary supplement comprising: un-defatted desiccated liver extract, amino acids, and an AKG hydroxylation agent, wherein the liver extract retains fat-soluble repair enzymes and vitamin A. In the field of the art, it is within the ambit of a skilled practitioner to produce a supplement comprising un-defatted desiccated liver extract, amino acids, and an AKG hydroxylation agent, wherein the liver extract retains enzymes and vitamin A by merely mixing un-defatted desiccated liver extract, amino acids, and AKG together. The state of the art at the time of filing shows that such ingredients were widely available and that a skilled practitioner is capable of modifying the proportions of each ingredient. However, such a composition comprising “fat-soluble” enzymes is not predictable as enzymes are proteins and proteins are water-soluble. The specification does not provide direction or disclose enough information for one of ordinary skill in the art to produce the product wherein the liver extract ingredient contains fat-soluble enzymes. Taking these factors into account, undue experimentation would be required by one of ordinary skill in the art to produce a product within the full scope of claims 1 and 17.
Claims 5-16 are rejected by reason of dependency from claim 1.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 5-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 17 recite “repair enzymes”. However, it is unclear as to what is meant by “repair enzymes” as enzymes are catalysts in chemical reactions; and the claims do not define what is meant by the term “repair” or disclose what component the enzyme is meant to repair. Therefore, the claims are indefinite. For the purpose of this examination, the “repair enzymes” will be interpreted as being just enzymes.
Claims 1 and 17 also recite “supplemental amino acids”. However, it is unclear as to what is meant by “supplemental amino acids” as these claims do not specify the inclusion of any other amino acids other than the “supplemental amino acids”; and do not specify the other component to which the amino acids are meant to supplement. Therefore, the claims are indefinite. For the purpose of this examination, the “supplemental amino acids” will be interpreted as being amino acids provided outside of the amino acids naturally occurring in the liver extract.
Claims 5, 6, and 7 refer to amino acids, but do not specify whether these amino acids refer to amino acids that are potentially present in the liver extract, amino acids provided outside of the amino acids potentially present in the liver extract (i.e., supplemental amino acids), or the total content of amino acids in the dietary supplement. Therefore, the claims are indefinite. For the purpose of this examination, the amino acids in these claims will be interpreted as referring to the total content of amino acids in the dietary supplement per [0013] of the present specification which states “each amino acid of the supplement is between about 1-200 mg”.
Claims 8-16 are rejected by reason of dependency from claim 1.
Claim Rejections - 35 USC § 103
Claims 1 and 5-17 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 2023/0117618) in view of Douglas (Douglas, B., “Beef Liver: The Bodybuilder’s Superfood”, 2020, NSP Nutrition, https://nspnutrition.com/blogs/articles/beef-liver-the-bodybuilders-superfood).
Regarding claim 1, 8, and 9, Johnson teaches a dietary supplement which triggers repair of a liver organ in humans comprising: un-defatted desiccated liver extract, amino acids, and AKG, wherein the amino acids and AKG are provided separately from and in addition to the liver extract [0029]-[0031]. Johnson teaches that the supplement contains AKG in an amount of 50-100 mg [0015], which falls within the claimed concentration recited in present claims 1, 8, and 9. Johnson teaches that the AKG hydroxylates amino acids to accelerate a repair process of the organ being treated [0012]. Johnson teaches that the liver extract contains vitamin A [0033]. Johnson does not teach that the liver extract contains enzymes.
However, Douglas teaches a desiccated liver extract which retains naturally-occurring enzymes, amino acids, vitamins, and minerals of the liver (page 5, 2nd paragraph under “Vince Gironda”).
It would have been obvious for a person of ordinary skill in the art to have modified the liver extract of Johnson to be the liver extract taught by Douglas. Since Johnson discloses that the supplement comprises un-defatted desiccated liver extract [0029]-[0031] which comprises vitamins, minerals, and amino acids [0033], but does not specify a particular desiccated liver extract, a skilled practitioner would have been motivated to consult an additional reference such as Douglas in order to determine a suitable desiccated liver extract comprising vitamins, minerals, and amino acids, thereby rendering the claimed liver extract obvious.
It is noted that claim 1 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon 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, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113.I. While Johnson discloses a dietary supplement comprising amino acids and AKG provided separately from the un-defatted desiccated liver extract, the determination of patentability is based upon the composition itself, not whether the amino acids and AKG were added to the supplement separately from the liver extract.
Regarding claims 5, 6, and 7, Johnson teaches the invention as described above in claim 1, including the amino acids include three or more of any combination of: glutamine, methionine, phenylalanine, tyrosine, tryptophan, proline, glycine, and arginine [0007] as recited in present claim 5. Johnson also teaches that the supplement comprises a dose of each amino acid in an amount of 5-200 mg [0015], which falls within the ranges recited in present claims 6 and 7.
Regarding claim 10, Johnson teaches the invention as described above in claim 1, including the supplement further comprising a buffering agent to protect active components of the supplement against stomach acidity [0024].
Regarding claims 11, 12, 13, 14, 15, and 16, Johnson teaches the invention as described above in claim 1, including the supplement further comprising extract components for treatment of the liver, lungs, brain, kidneys, thyroid, and/or skin, wherein the extract components include at least threonine, tryptophan, valine, histidine, proline, glycine, arginine, methionine, phenylalanine, tyrosine, glutamine, isoleucine, leucine, and/or lysine [0018]-[0023] as recited in present claims 11, 12, 13, 14, 15, and 16.
Regarding claim 17, Johnson teaches a dietary supplement which triggers repair of a liver organ in humans comprising: un-defatted desiccated liver extract, amino acids, and AKG, wherein the amino acids and AKG are provided separately from and in addition to the liver extract [0029]-[0031]. Johnson teaches that the amino acids include three or more of any combination of: glutamine, methionine, phenylalanine, tyrosine, tryptophan, proline, glycine, and arginine [0007]. Johnson teaches that the supplement contains AKG in an amount of 50-100 mg [0015], which falls within the claimed concentration recited in present claim 17. Johnson teaches that the AKG hydroxylates amino acids to accelerate a repair process of the organ being treated [0012]. Johnson teaches that the liver extract contains vitamin A [0033]; and that the liver extract treats a liver organ for fatty liver disease, liver cirrhosis, and liver spots [0008]. Johnson does not teach that the liver extract contains enzymes.
However, Douglas teaches a desiccated liver extract which retains naturally-occurring enzymes, vitamins, and minerals of the liver (page 5, 2nd paragraph under “Vince Gironda”).
It would have been obvious for a person of ordinary skill in the art to have modified the liver extract of Johnson to be the liver extract taught by Douglas. Since Johnson discloses that the supplement comprises un-defatted desiccated liver extract [0029]-[0031] which comprises vitamins, minerals, and amino acids [0033], but does not specify a particular desiccated liver extract, a skilled practitioner would have been motivated to consult an additional reference such as Douglas in order to determine a suitable desiccated liver extract comprising vitamins, minerals, and amino acids, thereby rendering the claimed liver extract obvious.
It is noted that claim 17 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon 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, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113.I. While Johnson discloses a dietary supplement comprising amino acids and AKG provided separately from the un-defatted desiccated liver extract, the determination of patentability is based upon the composition itself, not whether the amino acids and AKG were added to the supplement separately from the liver extract.
Claims 1, 5-9, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Amazon (“MuscleMeds Carnivor Beef Aminos, Beef Protein Isolate, Beef Liver, Beef Albumin, Creatine, BCAAs for Recovery and Muscle Growth, 300 Tablets”, 2012, https://www.amazon.com/Musclemeds-Carnivor-Aminos-Tablets-Count/dp/B008M9SDN2/ref=sr_1_5_mod_primary_new?crid=38BSJJ7Y3K8KI&dib=eyJ2IjoiMSJ9.aS1mfDYMBnBa0IU9qv9zuGjf9SizLZTm4q7XlhQRJ5OyOoNeWP9pYZN9cQTev8DVVlG8XQt0xuJPSvv7Mld_5qBfFpkQJgcYI2HZRfBE_i8PADU43pT9_jIT4j6Ip8jYfbHevXy91gM4_EQMHjO3-iLRMnN3o8xw37h-98ostvJbAE08LyLT2e4lkALkGxfPOem0QXSxl3GavBgSVglnEKg2oI-0zMkD4MCS1eXEHd9oSWTfyE3a-Pj8QsqcCbwlDGwkwpV2zazOCdOjcd59rB7YKZfWlyDLIolQFlyz8.eNVPXirITLN-UxX3lrEAF2Ns9MQPfdlTLkYr0YZtA8&dib_tag=se&keywords=muscle+meds+carnivor+beef+aminos&qid=1750781368&sbo=RZvfv%2F%2FHxDF%2BO5021pAnSA%3D%3D&sprefix=muscle+meds+carnivor+beef+aminos%2Caps%2C111&sr=8-5; previously cited) in view of Douglas (Douglas, B., “Beef Liver: The Bodybuilder’s Superfood”, 2020, NSP Nutrition, https://nspnutrition.com/blogs/articles/beef-liver-the-bodybuilders-superfood) as evidenced by Regulations (“Nutrition labeling of food”, 2026, 21 CFR 101.9, https://www.ecfr.gov/current/title-21/part-101/section-101.9) and Eriksson (Eriksson, A., "Desiccated Liver Pills: The Ultimate Superfood for Building Muscle", April 2021, Anabolic Health https://web.archive.org/web/20210420102516/https://www.anabolichealth.com/desiccated-liver-pills/; previously cited).
Regarding claims 1, 8, and 9, Amazon teaches a dietary supplement (corresponding to MuscleMeds Carnivor Beef Aminos) for building muscle comprising: desiccated liver, amino acids, and AKG, wherein the amino acids and AKG are provided separately from and in addition to the liver (1st page, 2nd – 3rd bullets under “About this item”; 1st page, Ingredients list in the box labeled “Just the Facts!”; 2nd page, paragraph under “Product Description”). Even if compounds are not extracted from liver to provide desiccated liver extract, the desiccated liver would still contain extracted components from the liver, thereby rendering the claimed liver extract obvious. Furthermore, desiccated liver contains natural vitamin A as evidenced by Eriksson (2nd page, 2nd bullet point after “Liver is”). Therefore, the desiccated liver of Amazon retains vitamin A as recited in present claim 1.
The prior art discloses that the supplement is fat-free and contains 0 g total fat (1st page, Ingredients list in the box labeled “Just the Facts!”). However, nutrition facts labels may state that a consumable product is fat-free and contains 0 g total fat if the product contains less than 0.5 g of fat per serving as evidenced by Regulations (page 8, section beginning with “(2)”). Therefore, the supplement of Amazon may contain fat. This feature is noted because Amazon does not specify that the desiccated liver in the supplement is un-defatted or defatted. However, the only two options for the desiccated liver is un-defatted or defatted and since the supplement of Amazon may comprise up to less than 0.5 g fat, both options are potentially included in the supplement as the desiccated liver. Un-defatted or defatted liver provides a genus of only two options, which represents a genus small enough so that un-defatted liver is able to be at once envisaged a skilled practitioner. MPEP §2131.02.III. For these reasons, the desiccated liver disclosed by Amazon is considered to render the claimed un-defatted desiccated liver extract obvious.
The prior art does not specifically state that the supplement triggers repair of a organs in humans. However, regarding product claims, when the ingredient recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be inherent. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s function, does not render the old composition patentably new to the discoverer.” Please see MPEP §2112 (I), Atlas Powder Co. v. IRECO Inc., 190 F .3d 1342, 1347, 51 USPQ2d 1943. 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function, or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. Please see MPEP §2112 (I), In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). As such, since the prior art teaches a dietary supplement comprising the claimed ingredients, the supplement of the prior art presumably has the same properties as the claimed supplement.
Amazon also teaches that a bottle of the dietary supplement contains 8 ounces of the supplement; and 300 tablets of the supplement wherein a dose of the supplement comprises 3 tablets (1st page, Ingredients list in the box labeled “Just the Facts!”; 1st page, “Item Weight”). Therefore, each tablet weighs 760 mg and each dose weighs 2,270 mg. Amazon does not specify the amount of AKG in the supplement. However, the minimum amount would be greater than 0 mg based on Amazon disclosing that AKG is in the supplement while the maximum amount would be less than the total weight of the dose. Therefore, the concentration of AKG is from greater than 0 mg to less than 2,270 mg, which encompasses the AKG contents recited in present claims 1, 8, and 9. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "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.I.
Amazon teaches that the supplement comprises desiccated liver (1st page, Ingredients list in the box labeled “Just the Facts!”); and that the supplement is for building muscle (2nd page, paragraph under “Product Description”). Amazon does not teach that the desiccated liver contains enzymes.
However, Douglas teaches a desiccated liver for building muscle which retains naturally-occurring enzymes of the liver (page 1, paragraphs under picture; page 5, 2nd paragraph under “Vince Gironda”).
It would have been obvious for a person of ordinary skill in the art to have modified the desiccated liver of Amazon to contain its naturally-occurring enzymes as taught by Douglas. Since Amazon discloses that the supplement comprises desiccated liver (1st page, Ingredients list in the box labeled “Just the Facts!”); and that the supplement is for building muscle (2nd page, paragraph under “Product Description”), but does not specify a particular desiccated liver component, a skilled practitioner would have been motivated to consult an additional reference such as Douglas in order to determine a suitable desiccated liver component for muscle building, thereby rendering the claimed liver extract comprising enzymes obvious.
It is noted that claim 1 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon 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, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113.I. While Amazon discloses a supplement comprising amino acids and AKG provided separately from the un-defatted desiccated liver extract, the determination of patentability is based upon the composition itself, not whether the amino acids and AKG were added to the supplement separately from the liver extract.
Regarding claims 5, 6, and 7, Amazon teaches the invention as described above in claim 1, including the amino acids include a combination of methionine, phenylalanine, and tryptophan (1st page, Ingredients list in the box labeled “Just the Facts!”). Amazon teaches that the bottle contains 8 ounces of the supplement; and 300 tablets of the supplement wherein a dose of the supplement comprises 3 tablets (1st page, Ingredients list in the box labeled “Just the Facts!”; 1st page, “Item Weight”). Therefore, each tablet weighs 760 mg and each dose weighs 2,270 mg. Amazon discloses that 100 g of the supplement contains 1,236 mg methionine, 2,504 mg phenylalanine, and 384 mg tryptophan (1st page, Ingredients list in the box labeled “Just the Facts!”) as recited by present claim 5. Therefore, each dose of the supplement contains 28 mg methionine, 57 mg phenylalanine, and 9 mg tryptophan, which falls within the claimed ranges recited in claims 6 and 7.
Regarding claim 17, Amazon teaches a dietary supplement (corresponding to MuscleMeds Carnivor Beef Aminos) for building muscle comprising: desiccated liver; a combination of the amino acids methionine, phenylalanine, tyrosine, tryptophan, proline, glycine, and arginine; and AKG, wherein the amino acids and AKG are provided separately from and in addition to the liver (1st page, 2nd – 3rd bullets under “About this item”; 1st page, Ingredients list in the box labeled “Just the Facts!”; 2nd page, paragraph under “Product Description”). Even if compounds are not extracted from liver to provide desiccated liver extract, the desiccated liver would still contain extracted components from the liver, thereby rendering the claimed liver extract obvious. Furthermore, desiccated liver contains natural vitamin A as evidenced by Eriksson (2nd page, 2nd bullet point after “Liver is”). Therefore, the desiccated liver of Amazon retains vitamin A as recited in present claim 17.
The prior art discloses that the supplement is fat-free and contains 0 g total fat (1st page, Ingredients list in the box labeled “Just the Facts!”). However, nutrition facts labels may state that a consumable product is fat-free and contains 0 g total fat if the product contains less than 0.5 g of fat per serving as evidenced by Regulations (page 8, section beginning with “(2)”). Therefore, the supplement of Amazon may contain fat. This feature is noted because Amazon does not specify that the desiccated liver in the supplement is un-defatted or defatted. However, the only two options for the desiccated liver is un-defatted or defatted and since the supplement of Amazon may comprise up to less than 0.5 g fat, both options are potentially included in the supplement as the desiccated liver. Un-defatted or defatted liver provides a genus of only two options, which represents a genus small enough so that un-defatted liver is able to be at once envisaged a skilled practitioner. MPEP §2131.02.III. For these reasons, the desiccated liver disclosed by Amazon is considered to render the claimed un-defatted desiccated liver extract obvious.
The prior art does not specifically state that the supplement triggers repair of a organs in humans. However, regarding product claims, when the ingredient recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be inherent. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s function, does not render the old composition patentably new to the discoverer.” Please see MPEP §2112 (I), Atlas Powder Co. v. IRECO Inc., 190 F .3d 1342, 1347, 51 USPQ2d 1943. 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function, or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. Please see MPEP §2112 (I), In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). As such, since the prior art teaches a dietary supplement comprising the claimed ingredients, the supplement of the prior art presumably has the same properties as the claimed supplement.
Amazon also teaches that a bottle of the dietary supplement contains 8 ounces of the supplement; and 300 tablets of the supplement wherein a dose of the supplement comprises 3 tablets (1st page, Ingredients list in the box labeled “Just the Facts!”; 1st page, “Item Weight”). Therefore, each tablet weighs 760 mg and each dose weighs 2,270 mg. Amazon does not specify the amount of AKG in the supplement. However, the minimum amount would be greater than 0 mg based on Amazon disclosing that AKG is in the supplement while the maximum amount would be less than the total weight of the dose. Therefore, the concentration of AKG is from greater than 0 mg to less than 2,270 mg, which encompasses the AKG contents recited in present claim 17. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "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.I.
Amazon teaches that the supplement comprises desiccated liver (1st page, Ingredients list in the box labeled “Just the Facts!”); and that the supplement is for building muscle (2nd page, paragraph under “Product Description”). Amazon does not teach that the desiccated liver contains enzymes.
However, Douglas teaches a desiccated liver for building muscle which retains naturally-occurring enzymes of the liver (page 1, paragraphs under picture; page 5, 2nd paragraph under “Vince Gironda”).
It would have been obvious for a person of ordinary skill in the art to have modified the desiccated liver of Amazon to contain its naturally-occurring enzymes as taught by Douglas. Since Amazon discloses that the supplement comprises desiccated liver (1st page, Ingredients list in the box labeled “Just the Facts!”); and that the supplement is for building muscle (2nd page, paragraph under “Product Description”), but does not specify a particular desiccated liver component, a skilled practitioner would have been motivated to consult an additional reference such as Douglas in order to determine a suitable desiccated liver component for muscle building, thereby rendering the claimed liver extract comprising enzymes obvious.
It is noted that claim 17 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon 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, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113.I. While Amazon discloses a supplement comprising amino acids and AKG provided separately from the un-defatted desiccated liver extract, the determination of patentability is based upon the composition itself, not whether the amino acids and AKG were added to the supplement separately from the liver extract.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Amazon (“MuscleMeds Carnivor Beef Aminos, Beef Protein Isolate, Beef Liver, Beef Albumin, Creatine, BCAAs for Recovery and Muscle Growth, 300 Tablets”, 2012, https://www.amazon.com/Musclemeds-Carnivor-Aminos-Tablets-Count/dp/B008M9SDN2/ref=sr_1_5_mod_primary_new?crid=38BSJJ7Y3K8KI&dib=eyJ2IjoiMSJ9.aS1mfDYMBnBa0IU9qv9zuGjf9SizLZTm4q7XlhQRJ5OyOoNeWP9pYZN9cQTev8DVVlG8XQt0xuJPSvv7Mld_5qBfFpkQJgcYI2HZRfBE_i8PADU43pT9_jIT4j6Ip8jYfbHevXy91gM4_EQMHjO3-iLRMnN3o8xw37h-98ostvJbAE08LyLT2e4lkALkGxfPOem0QXSxl3GavBgSVglnEKg2oI-0zMkD4MCS1eXEHd9oSWTfyE3a-Pj8QsqcCbwlDGwkwpV2zazOCdOjcd59rB7YKZfWlyDLIolQFlyz8.eNVPXirITLN-UxX3lrEAF2Ns9MQPfdlTLkYr0YZtA8&dib_tag=se&keywords=muscle+meds+carnivor+beef+aminos&qid=1750781368&sbo=RZvfv%2F%2FHxDF%2BO5021pAnSA%3D%3D&sprefix=muscle+meds+carnivor+beef+aminos%2Caps%2C111&sr=8-5; previously cited) in view of Douglas (Douglas, B., “Beef Liver: The Bodybuilder’s Superfood”, 2020, NSP Nutrition, https://nspnutrition.com/blogs/articles/beef-liver-the-bodybuilders-superfood) as evidenced by Regulations (“Nutrition labeling of food”, 2026, 21 CFR 101.9, https://www.ecfr.gov/current/title-21/part-101/section-101.9) and Eriksson (Eriksson, A., "Desiccated Liver Pills: The Ultimate Superfood for Building Muscle", April 2021, Anabolic Health https://web.archive.org/web/20210420102516/https://www.anabolichealth.com/desiccated-liver-pills/; previously cited) as applied to claim 1 above, and further evidenced by Bell (“Dicalcium Phosphate in the Food Industry”, 2025, Bell Chem, https://web.archive.org/web/20250429004308/https://www.bellchem.com/news/dicalcium-phosphate-in-the-food-industry).
Regarding claim 10, Amazon teaches the invention as describe above in claim 1, including the supplement further comprising dicalcium phosphate (1st page, Ingredients list in the box labeled “Just the Facts!”). Dicalcium phosphate is a buffering agent as evidenced by Bell (1st paragraph). Therefore, Amazon discloses a supplement containing a buffering agent to protect against stomach acidity as presently claimed.
Claims 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Amazon (“MuscleMeds Carnivor Beef Aminos, Beef Protein Isolate, Beef Liver, Beef Albumin, Creatine, BCAAs for Recovery and Muscle Growth, 300 Tablets”, 2012, https://www.amazon.com/Musclemeds-Carnivor-Aminos-Tablets-Count/dp/B008M9SDN2/ref=sr_1_5_mod_primary_new?crid=38BSJJ7Y3K8KI&dib=eyJ2IjoiMSJ9.aS1mfDYMBnBa0IU9qv9zuGjf9SizLZTm4q7XlhQRJ5OyOoNeWP9pYZN9cQTev8DVVlG8XQt0xuJPSvv7Mld_5qBfFpkQJgcYI2HZRfBE_i8PADU43pT9_jIT4j6Ip8jYfbHevXy91gM4_EQMHjO3-iLRMnN3o8xw37h-98ostvJbAE08LyLT2e4lkALkGxfPOem0QXSxl3GavBgSVglnEKg2oI-0zMkD4MCS1eXEHd9oSWTfyE3a-Pj8QsqcCbwlDGwkwpV2zazOCdOjcd59rB7YKZfWlyDLIolQFlyz8.eNVPXirITLN-UxX3lrEAF2Ns9MQPfdlTLkYr0YZtA8&dib_tag=se&keywords=muscle+meds+carnivor+beef+aminos&qid=1750781368&sbo=RZvfv%2F%2FHxDF%2BO5021pAnSA%3D%3D&sprefix=muscle+meds+carnivor+beef+aminos%2Caps%2C111&sr=8-5) in view of Douglas (Douglas, B., “Beef Liver: The Bodybuilder’s Superfood”, 2020, NSP Nutrition, https://nspnutrition.com/blogs/articles/beef-liver-the-bodybuilders-superfood) as evidenced Regulations (“Nutrition labeling of food”, 2026, 21 CFR 101.9, https://www.ecfr.gov/current/title-21/part-101/section-101.9) and Eriksson (Eriksson, A., "Desiccated Liver Pills: The Ultimate Superfood for Building Muscle", April 2021, Anabolic Health https://web.archive.org/web/20210420102516/https://www.anabolichealth.com/desiccated-liver-pills/; previously cited) as applied to claim 1 above, and further evidenced by Eat (“Beef Liver”, 2025, Eat This Much, https://www.eatthismuch.com/calories/beef-liver-2766).
Regarding claims 11, 12, 13, 14, 15, and 16, Amazon teaches the invention as described above in claim 1, including the supplement comprises beef liver (1st page, Ingredients list in the box labeled “Just the Facts!”). Beef liver contains threonine, tryptophan, valine, histidine, proline, glycine, arginine, methionine, phenylalanine, tyrosine, glutamine, isoleucine, leucine, and/or lysine as evidenced by Eat (page 2, section under “Amino Acids”). Therefore, the beef liver in the supplement of Amazon contains threonine, tryptophan, valine, histidine, proline, glycine, arginine, methionine, phenylalanine, tyrosine, glutamine, isoleucine, leucine, and/or lysine so that the supplement further comprises the liver extract components threonine, tryptophan, valine, histidine, proline, glycine, arginine, methionine, phenylalanine, tyrosine, glutamine, isoleucine, leucine, and/or lysine as recited in present claims 11, 12, 13, 14, 15, and 16.
The prior art does not specifically state that the components are for treating the liver, lungs, brain, kidneys, thyroid, or skin. However, regarding product claims, when the ingredient recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be inherent. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s function, does not render the old composition patentably new to the discoverer.” Please see MPEP §2112 (I), Atlas Powder Co. v. IRECO Inc., 190 F .3d 1342, 1347, 51 USPQ2d 1943. 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function, or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. Please see MPEP §2112 (I), In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). As such, since the prior art teaches a dietary supplement comprising the claimed ingredients, the supplement of the prior art presumably has the same properties as the claimed supplement.
Response to Arguments
Claim Objection: Applicant amended claim 1 to fully address the objection; therefore, the objection is withdrawn.
Claim Rejections – 35 U.S.C. §103 of claims 1, 5-9, and 11-17 over Amazon as evidenced by Zupke: Applicant’s arguments and amendments have been fully considered and are not considered to overcome the presently cited prior art.
Applicant amended claims 1 and 17 to recite that: (A) the liver extract retains enzymes and vitamin A; (B) amino acids are provided in addition to the liver extract; and (C) the dietary supplement comprises at least 10 mg of AKG. Applicant argued that the dietary supplement of Amazon does not contain any fat as denoted by the product of Amazon being labeled as containing 0 grams of fat in the Supplement Facts table and, thus, the supplement of Amazon cannot contain non-defatted liver extract as non-defatted liver extract comprises fat. Applicant argued that the analysis in the previous Office Action that the “Fat free” product of Amazon may contain up to 0.5 g of fat as evidenced by Zupke conflates regulatory labeling allowances with compositional reality. Applicant argued that the defatted liver extract used in the Amazon product to achieve its “0 g Fat/Cholesterol Free” label is processed to remove its lipid fraction and that this processing also removes lipophilic vitamins such as vitamin A. For this reason, Applicant argued that Amazon’s explicit disclosure of a “Fat Free” genus teaches away from the claimed “un-defatted” liver extract that retains its fat-soluble components (Applicant’s Remarks, page 7, 1st paragraph under “First Claim Rejection” – page 8, 1st paragraph).
However, Amazon does not explicitly disclose whether its desiccated liver is non-defatted or defatted, but does disclose that its product is “fat-free” and contains 0 grams of total fat (1st page, Ingredients list in the box labeled “Just the Facts!”). However, nutrition facts labels may state that a consumable product, such as the dietary supplement of Amazon, is fat-free and contains 0 g total fat if the product contains less than 0.5 g of fat per serving as evidenced by Regulations (page 8, section beginning with “(2)”). This cited Regulations reference demonstrates that the analysis supporting the inclusion of less than 0.5 g total fat in the supplement of Amazon does not conflate regulatory labeling allowances with compositional reality as this Regulations reference sets the standard for regulatory labeling. This reference also demonstrates that Amazon’s disclosure of a “Fat Free” genus does not teach away from the claimed “un-defatted” liver extract as asserted by the Applicant.
Applicant then argued that the Amazon product relies on beef protein isolate, beef albumin, and dried beef liver for the amino acid profile in the product. Applicant stated that the present claims require “supplemental amino acids provided separately from and in addition to” the liver extract. Applicant argued that the present claims require the addition of free-form amino acids to target organ repair, which is different than the “muscle growth” objective of the Amazon product (Applicant’s Remarks, page 8, 2nd paragraph; page 8, 3rd paragraph – page 9, 2nd paragraph).
However, the Examiner points out that the phrase “ “supplemental amino acids provided separately from and in addition to” the liver extract” does not equate to free amino acids wherein the free amino acids are not bound by peptide bonds. The phrase merely means that amino acids beyond those found in the liver extract are included in the claimed product. The phrase does not imply any actual structure to the amino acids themselves (i.e., peptide bound or not peptide bond). Therefore, Applicant’s arguments regarding such a feature are moot and the beef protein isolate and beef albumin in the Amazon product qualify as the claimed “amino acids provided separately from and in addition to” the liver extract”. Furthermore, Applicant has not demonstrated criticality of the asserted free amino acids over peptide-bound amino acids.
Applicant then stated that the present claims require the dietary supplement contain “at least 10 mg” of AKG. Applicant argued that this amount of AKG is no longer anticipated by the hypothetical presence of “greater than 0 mg” in the prior art. Applicant argued that in the supplement arts, unquantified ingredients listed alongside excipients or in “complexes” are often present in non-therapeutic, trace amounts (Applicant’s Remarks, page 8, 3rd – 4th paragraphs; page 9, 5th paragraph – page 10, 2nd paragraph).
It is noted that claims 1, 5-9, and 11-17 in the previous claim set were rejected as being obvious by the prior art, not as being anticipated by the prior art; therefore, Applicant’s statements of anticipation of the claims by the prior art are moot. However, in response to Applicant’s assertion that the prior art does not disclose the supplement comprising at least 10 mg of AKG, Amazon teaches that a bottle of its supplement contains 8 ounces of the supplement; and that the bottle contains 300 tablets of the supplement wherein a dose of the supplement comprises 3 tablets (1st page, Ingredients list in the box labeled “Just the Facts!”; 1st page, “Item Weight”). Therefore, each tablet weighs 760 mg and each dose weighs 2,270 mg. Although does not specify the amount of AKG in the supplement, the minimum amount of AKG would necessarily be greater than 0 mg based on Amazon disclosing that AKG is in the supplement while the maximum amount would necessarily be less than the total weight of the dose. Therefore, the concentration of AKG in the supplement of Amazon is from greater than 0 mg to less than 2,270 mg, which encompasses the claimed AKG concentration. The selection of a value within the overlapping range renders the claimed AKG concentration obvious, especially wherein the Applicant has not demonstrated criticality of the claimed AKG content. MPEP 2144.05.I. “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).” MPEP §716.02(d)II.
In response to Applicant’s assertion that in the supplement arts, unquantified ingredients listed alongside excipients or in “complexes” are often present in non-therapeutic, trace amounts, Applicant’s argument is conclusory in nature, lacks evidence or persuasive technical reasoning for support, and does not otherwise sufficiently establish that the product of Amazon comprises less than 10 mg of AKG and/or comprises only a non-therapeutic, trace amount of AKG. For this reason, Applicant’s argument is given little weight.
Applicant then argued that the amounts of amino acids recited in claims 6 and 7 refer to the weight of the free amino acids in the dietary supplement, not the content of the bulk protein. Applicant argued that the prior art does not teach the claimed contents of individual free-form amino acids as the prior art teaches the ingestion of grams of bulk protein (Applicant’s Remarks, page 9, 3rd paragraph).
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., free-form amino acids) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As stated in Examiner’s response above, the phrase “ “supplemental amino acids provided separately from and in addition to” the liver extract” does not equate to free amino acids wherein the free amino acids are not bound by peptide bonds. The phrase merely means that amino acids beyond those found in the liver extract are included in the claimed product. The phrase does not imply any actual structure to the amino acids themselves (i.e., peptide bound or not peptide bond). Therefore, Applicant’s arguments regarding such a feature are moot and the beef protein isolate and beef albumin in the Amazon product qualify as the claimed “amino acids provided separately from and in addition to” the liver extract”.
Since the prior art has been shown to render the present claims obvious and Applicant’s arguments have been shown to be unpersuasive or moot, the rejections of the claims stand as written herein.
Claim Rejections – 35 U.S.C. §103 of claim 10 over Amazon as evidenced by Zupke and Bell: Applicant’s arguments have been fully considered and are not considered to overcome the presently cited prior art.
Applicant argued that claim 10 is patentable by reason of dependency from claim 1. Applicant also argued that the dicalcium phosphate of the supplement of Amazon functions as a binder/filler and not as a buffering agent against stomach acidity is presently claimed. Applicant argued that a skilled practitioner would not have considered the dicalcium phosphate of the supplement of Amazon to be a buffering agent due to buffering agents generally being specific alkaline agents that are present in substantial quantities in a product (Applicant’s Remarks, page 10, section labeled “Second Claim Rejection”).
It is noted that claim 10 in the previous claim set was rejected as being obvious by the prior art, not as being anticipated by the prior art (i.e., the statement “Claim 10 is rejected under 35 U.S.C. 102(a)(1) as anticipated by” was a typo as demonstrated at least by claim 10 being dependent from a claim that was rejected for obviousness); therefore, Applicant’s statement of anticipation of the claim by the prior art is moot.
However, the Examiner points out that dicalcium phosphate, such as that in the supplement of Amazon, is an alkaline agent. The Examiner also points out that there is no specific amount of buffering agent required by the present claims or required in the field of the art to buffer a solution, especially wherein the claims do not require any degree of stomach acid neutralization/buffering or degree of protection against stomach acidity. Therefore, Applicant’s arguments regarding the dicalcium phosphate of the supplement of Amazon not being a buffering agent are not supported. As such, the rejection of claim 10 stands as written herein.
Claim Rejections – 35 U.S.C. §103 of claims 14-15 over Amazon as evidenced by Zupke and Wu: Applicant’s arguments have been fully considered and are not considered to overcome the presently cited prior art.
Applicant argued that claims 14 and 15 are patentable by reason of dependency from claim 1. Applicant argued that the amino acids recited in claims 14 and 15 are the “supplemental amino acids” recited in present claim 1. For this reason, Applicant argued that the glutamine present in the liver extract as part of the inherent protein of the liver cannot satisfy the requirement that the glutamine be added to the liver extract (Applicant’s Remarks, page 11, section labeled “Third Claim Rejection”).
It is noted that claim 14 and 15 in the previous claim set was rejected as being obvious by the prior art, not as being anticipated by the prior art (i.e., the statement “Claims 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by” was a typo as demonstrated at least by claims 14 and 15 being dependent from a claim that was rejected for obviousness); therefore, Applicant’s statement of anticipation of the claim by the prior art is moot.
However, claims 14 and 15 recite that the amino acids are “extract components” wherein the term “extract” in this phrase is interpreted as being “the un-defatted desiccated liver extract” recited in present claim 1. Therefore, amino acids in present claims 14 and 15 are components of the liver extract and are not the “supplemental amino acids” that are provided outside of the amino acids in the liver extract as is asserted by the Applicant.
Since the prior art is shown to render the present claims obvious and Applicant’s arguments are shown to be unpersuasive, the rejections of the claims stand as written herein.
Conclusion
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/KELLY P KERSHAW/Examiner, Art Unit 1791