DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claim
Claims 1, 3, 5, 7-16 and 26-38 are pending in this application and are under examination. Claims 2, 4, 6, and 17-25 are canceled. Any objections or rejections not repeated below have been withdrawn.
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, 5, 7-16 and 26-38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter recited in 35 U.S.C. 101 (process, machine, manufacture, or composition of matter).
The claimed invention is directed to mental processes without significantly more. The claims recite determining steps. These determining steps, as drafted, are processes that under their broadest reasonable interpretation, covers mentally performing the limitation. That is, nothing in the claim element precludes the determining, predicting and comparing steps from practically being performed in the human mind. Or in other words, the determining, predicting and comparing steps as recited in lines 3-20 in claim 1 read on mentally calculating amounts of urea, a protein source, peptides, rumen-protected peptides, amino acids, or any combination thereof and not any physical steps to be performed. Nothing is preventing an individual, when performing the method steps, to do so by mentally calculating the amounts that need to be added to the unaltered diet of the ruminant to supplement their nutrition where it is deficient. No language recitation within the claims takes the claim limitations out of the mental processes grouping.
Further, the specification does not appear to contain any definitions that when applied to the claim language result in any processes that cannot be performed mentally. A method of preparing and feeding an adjusted diet to a ruminant is nothing more than normal, routine and conventional and does not amount to more than the abstract idea. It is normal to adjust a diet and for a diet to be fed to an animal. Even taking into consideration the comparing steps to identify an amino acid deficiency, nothing more than feeding an adjusted diet is performed. Additionally, it is noted that an unaltered diet could still meet the amino acids needs of the ruminant, leading to the ruminant not needing any remedy to an amino acid deficiency, since an amino acid deficiency may or may not even be present in the ruminant. Thus, the claims recite mental processes. This judicial exception is not integrated into a practical application because the claimed method steps can be performed through mental processes. The claims, including the dependent claims, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because rejected claims only contain mental process steps to determine the amount of supplement that should be added to the ruminant diet, which are mere instructions that are nothing more than normal, routine and conventional.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5, 7-16 and 26-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sato et al. (US Patent No. 5906842). Hereinafter, Sato.
Regarding claims 1 and 33 recitation of the determining, predicting, and comparing method steps, these are all mental process steps and are not physical steps that require an action to be performed. These mental process steps of determining, predicting, and comparing do not provide further specificity to the performed method. For instance, “determining an amino acid requirement of a ruminant based at least in part upon the effective energy requirement of the ruminant” reads on thinking about any amount of desired amino acid and on any amount of desired energy for the ruminant. The same applies to the other determining, predicting and comparing steps recited in claims 1 and 33 - they are broad and read on any amount of energy and amino acid requirement. Also, the four recitations of, “at least in part” in lines 4, 6, 11 and 18 in these mental process limitations of claims 1 and 33, can be construed as being based on any part, however large or small. Additionally, any data of unaltered diets and ingredients, (e.g. measurements of the unaltered diet, measured feed intake, measurements of the unaltered diet consumed by the ruminant) are considered to be part of the calculations and are data used to complete the calculations, and not physical steps like preparing, mixing, and administering. Accordingly, as long as any amount of amino acids are being determined to add to the diet it will be considered to meet the claim limitations.
It is also noted that the only physical step performed in the claims are preparing and administering the composition to the ruminant. Accordingly, anything that teaches preparing a diet and feeding a ruminant will be considered to meet the claim limitations.
Regarding independent claims 1 and 33, Sato teaches a method of treating an amino acid deficiency in a ruminant (a method to correct in dairy cows an insufficient absorption of protein by supplementing amino acids (RPAA) to achieve effective absorption of the protein/amino acids; C3 L5-15, C4 L36-59), comprising determining an index showing amino acid sufficiency, or amino acid requirement for dairy cows. This is found by looking at the difference of (A) and (B) to set a dose of rumen-protected amino acids (hereinafter, RPAA). Where (A) is the requirement “of amino acids constituting the protein” and (B) is the amount “of the amino acids fed for the protein synthesis,” which is used to determine the protein requirement for keeping the body weight of the dairy cow and protein requirement for producing 40 kg/day of milk having protein content of 3% (C4, L:18-58). Thus, Sato teaches a determining step for rumen-protected amino acids that meets amino acid requirements for a ruminant.
Sato teaches a method of preparing an adjusted diet by mixing feed ingredients, where RPAA is incorporated into corn-based mixed diet (C4, L:59-65) and administering the adjusted diet and dietary supplement to the ruminants (dairy cows) (C3 L:5-10; C4 L:59-65; C5 L:14-24). Sato discloses the amino acids may be a mixture of predetermined amounts (C3 L:20-25), where the amounts are calculated by using a protein requirement calculation (C4 L:18-25). Thus, remedying or treating any amino acid deficiency that may or may not be present in the ruminant, since the adjusted diet is prepared by mixing predetermined amounts of amino acids that meet a protein requirement.
In the instant case, Sato teaches the positively recited and tangible method steps as recited in claim 1 and 33, which is preparing and administering a composition to a ruminant. Therefore, the claims are anticipated by Sato.
Regarding claim 3, it is noted the method steps of “determining the quantity” in lines 1-2 or “determining a quantity” in line 4 are mental steps and not tangible step that are being performed by the claim and read on any quantity. Therefore, anything that teaches an unaltered diet consumed by a ruminant, where the unaltered diet has any amount of protein, starch, and fiber content, will be considered to meet the claim.
Sato teaches determining an unaltered diet in a cow, which comprises determining protein, starch, and fiber content of the unaltered diet. In column 8 Table 3 Sato shows determining a diet composition for a cow. The amount of diet, in kg/day, the cow is consuming is determined by the dry matter intake/body wt. of the cow (%). As noted at C7 L: 50-67, Sato teaches a method of giving a cow a diet, as found in column 8 Table 3, that does not have rumen-protected lysine (RPLys) and rumen-protected methionine (RPMet) added to the feed. The specific composition of the diet, i.e., the materials in the diet, are given in column 9 Table 4. It is evident that each material listed has a defined amount of protein, starch, and fiber content. Further, since the weight percent composition is given, the amounts of protein, starch, and fiber are readily ascertainable. Accordingly, Sato discloses an unaltered ruminant diet that has materials of the diet listed, where these materials each have their own amount of protein, starch, and fiber content. In the instant case, Sato teaches every limitation recited in claim 3.
Regarding claims 5 and 34, it is noted the method steps of “determination” is a mental step and not a tangible step that is being performed by the claim. Therefore, anything that teaches a composition to be fed to a ruminant basing the composition off of the amount needed by the ruminant, will be considered to meet the claim.
Sato teaches determining a diet for a cow. In column 8 Table 3 Sato shows determining a diet composition for a cow. The amount of diet, in kg/day, the cow is consuming is determined by the dry matter intake/body wt. of the cow (%). At C7 L: 50-67, Sato teaches a method of giving a cow a feed mixture diet, as found in column 8 Table 3. The specific composition of the diet, materials in the diet, are given in column 9 Table 4. Accordingly, Sato teaches determining a composition to be fed to a cow based on the amount needed by the cow, which is a ruminant.
Regarding claim 7, it is noted the method step of “determining” is a mental step and not a tangible step that is being performed by the claim. The entirety of claim 7 is directed toward the mental step of determining and this mental step is not linked to any tangible quantity or steps required by the claim. Therefore, anything that teaches determining a diet for a ruminant, will be considered to meet the claim.
Sato teaches a method as discussed above in claim 1 and therefore is considered to teach determining a diet for a ruminant.
Regarding claim 8, it is noted that this claim is also a mental step that has the method step of determining a “prediction,” which is not a tangible step that is being performed by the claim. The entirety of claim 8 is directed toward the mental step of determining a “prediction” and this mental step is not linked to any tangible quantity or steps required by the claim. Therefore, anything that teaches determining a diet for a ruminant, will be considered to meet the claim.
Sato teaches a method as discussed above in claims 1 and 7 and therefore is considered to teach determining a diet for a ruminant.
Regarding claim 9, it is noted the method step of “determining” is a mental step and not a tangible step that is being performed by the claim. The entirety of claim 9 is directed toward the mental steps of determining and these mental steps are not linked to any tangible quantity or steps required by the claim. Therefore, anything that teaches determining a diet for a ruminant, will be considered to meet the claim.
Sato teaches determining a diet for a cow. As noted, at C7 L: 50-67, Sato teaches a method of determining a feed mixture diet for a cow, as found in column 8 Table 3, where rumen-protected amino acids, specifically rumen-protected lysine (RPLys) and rumen-protected methionine (RPMet), were also added to the diet. The specific composition of the diet or materials in the diet, are given in column 9 Table 4, and include soybean meal, corn gluten meal, and rapeseed meal or canola meal, all sources of protein as discussed in the previous paragraph.
Regarding claim 9 recitation of “a rumen microbial peptide nitrogen or amino acid-nitrogen” and a “rumen microbial ammonia-nitrogen,” the specification further clarifies these requirements are fulfilled or supplied by an amount of urea, protein, peptides, RPP (rumen-protected peptides), RPAA (rumen-protected amino acids), or any combination thereof. The specification gives examples of protein sources including fishmeal, bloodmeal, soybean meal, canola meal, cottonseed meal, corn gluten feed, dried distillers’ grains, and combinations thereof (pg. 13, L:18-31; pg. 14, L:1-4). Therefore, determining an amount of urea, protein, peptides, RPP, RPAA, or any combination thereof to add to a diet will be considered to meet the claim limitations. Accordingly, Sato discloses determining an amount of protein and rumen-protected amino acids to add to a diet for a cow.
Regarding claim 10, It is noted, ”comparing” is a mental step and not a tangible step that is being performed by the claim. Therefore, anything that teaches comparing urea, protein, peptides, RPP, RPAA, or any combination thereof from the unaltered diet to the requirement will be considered to meet the claim limitations.
Sato teaches a method as discussed above in claim 9. Sato teaches comparing amino acids in the unaltered diet to the amino acids and rumen-protected amino acids, RPLys and RPMet, of the requirement or supplemented diet (C7, L:50-67; Tables 5-8). Thus, Sato discloses a protein comparison from the unaltered diet to the requirement
Regarding claim 11, it is noted, “determining” is a mental step and not a tangible step that is being performed by the claim. Also, the recitation of “at least in part” in line 3, is being construed as being based on any part, however large or small. Therefore, anything that teaches determining any amount of urea, protein source, peptides, amino acids, or any combination thereof will be considered to meet the claim limitations. Therefore, Sato discloses determining an amount of protein and rumen-protected amino acids.
Sato teaches a method as discussed above in claim 10. Sato teaches at C7 L: 50-67, a method of determining a feed mixture diet for a cow, as found in column 8 Table 3, where amino acids, specifically rumen-protected lysine (RPLys) and rumen-protected methionine (RPMet), were added to a diet. The specific composition of the diet or materials in the diet, are given in column 9 Table 4, and include soybean meal, corn gluten meal, and rapeseed meal or canola meal, all sources of protein.
Regarding claim 12, Sato teaches a method of determining a feed mixture diet for a cow, as found in column 8 Table 3, where amino acids (rumen-protected amino acids) are a supplement, or dietary supplement, added to the feed (C3, L:20-40; C7, L:50-67).
Regarding claim 13, Sato teaches a method where the ruminant is a cow, or bovine, and the amino acids are methionine and lysine (C2, L:37-40; C2, L:55-65).
Regarding claim 14, Sato teaches a method of determining a feed mixture diet, or dietary supplement, for a cow (C7 L: 50-67; C8 Table 3). The specific composition of the materials in the dietary supplement, are given in column 9 Table 4, and include soybean meal, corn gluten meal, and rapeseed meal or canola meal, all sources of protein. Therefore, Sato discloses a dietary supplement comprising a protein source.
Regarding claim 15, Sato teaches an additional protein source from an appetizer consumed as part of the adjusted diet. The appetizer can be chosen from among roasted soybean flour, brewers’ grains, and rice bran, all of which are additional protein sources (C3 L:5-20 and 45-55).
Regarding claims 16 and 35, It is noted, determining the effective energy requirement in claim 1 and determining the metabolizable energy requirement in claim 33, which are then used to calculate the essential amino acids per megajoule of effective energy in claim 16 or to calculate the essential amino acids per megajoule of metabolizable energy in claim 35, are all mental steps and not tangible steps that are being performed by the claims. Also, the claim reads on any amount of effective energy. Therefore, anything that teaches an adjusted diet, dietary supplement, or the combination thereof that contains any Lys, Met, His, Phe, Thr, Leu, Val, Arg, Ile, Trp, or any combination thereof, will be considered to meet the claim limitations.
Sato teaches a method of giving a cow a diet with added RPLys and RPMet or an adjusted diet (C7 L: 50-67). Tables 5-8 outline the amino acids found in the adjusted diet which include Val, Met, Ile, Leu, Phe, Lys, His, Arg, and Thr.
Regarding claim 16 recitation, “for growing animals,” and claim 35 recitation, “for lactating animals,” after a careful review of the claim and specification, it is found the recitation “for growing animals” and “for lactating animals” does not further limit the claim. Said recitation is merely directed at the intended use of the claimed method. See MPEP 2111.02. Therefore, considering all of the above, Sato, which teaches the amino acids Val, Met, Ile, Leu, Phe, Lys, His, Arg, and Thr are found in the adjusted diet, is considered to meet claims 16 and 35.
Regarding claim 26, it is noted the method step of “determining” is a mental step and not a tangible step that is being performed by the claim. The entirety of claim 26 is directed toward the mental step of determining and this mental step is not linked to any tangible quantity or steps required by the claim. Therefore, anything that teaches determining a diet for a ruminant, will be considered to meet the claim.
Sato teaches a method as discussed above in claims 1 and 7 and therefore is considered to teach determining a diet for a ruminant.
Regarding claim 27, Sato teaches the amino acids are methionine and lysine (C2, L:55-65), which are both essential amino acids.
Regarding claim 28, Sato teaches a method of determining a feed mixture diet, or dietary supplement, for a cow (C7 L: 50-67; C8 Table 3). The specific composition of the materials in the dietary supplement, are given in column 9 Table 4, and include soybean meal, corn gluten meal, and rapeseed meal or canola meal, all sources of protein which contain peptides. Therefore, Sato discloses a dietary supplement comprising peptides.
Regarding claims 29, 30 and 37, It is noted claims 29, 30 and 37 contain mental steps for determining a specific type of energy or energy requirement for the ruminant. These mental steps are done with specific formulas either the ruminant’s effective energy (EE) in claim 29, the effective energy requirement of the ruminant in claim 30, or the metabolizable energy requirement of the ruminant in claim 37. These equations are all mental steps and are not linked to any tangible quantity or steps required by the claims. Therefore, anything that teaches a dietary supplement for a ruminant will be considered to meet the claim.
Sato teaches a method of determining a feed mixture diet, or dietary supplement, for a cow (C7 L: 50-67; C8 Table 3).
Regarding claim 31, Sato teaches preparing the adjusted diet comprising adding a protein source to the unaltered diet (adding amino acids to meet the amino acid requirement; C4 L:37-58, pg. 7 Tables 5-8), changing a protein source in the unaltered diet (changing the protein to contain rumen-protected amino acids (RPAA); C1 L:35-48, C3 L:20-30, pg. 7 Tables 5-8), adjusting an amount of a protein source present in the unaltered diet (adjusting the amount of rumen protected methionine (RPMet) and rumen protected lysine (PRLys); C4 L:37-58, pg. 7 Tables 5-8), or any combination thereof.
Sato also teaches preparing the dietary supplement comprising preparing a powder supplement, a granular supplement, a liquid supplement, or any combination thereof (the amino acids (RPAA) can be in the form of a powder or aqueous solution; C4 L:59-67 to C5 L:1-5).
Regarding claim 32, Sato teaches the amino acids comprise rumen protected amino acids (C1 L:35-48, C3 L:20-30, pg. 7 Tables 5-8, Claims 1 and 8).
Regarding claim 36, it is noted the determining steps recited in the claim are mental steps and not tangible steps that are being performed by the claim. Therefore, anything that teaches determining a ruminant diet and the quantity or amount of diet consumed by the ruminant, will be considered to meet the claim limitations.
Sato teaches determining a diet for a cow. In column 8 Table 3 Sato shows determining a diet composition for a cow. The quantity or amount of diet, in kg/day, the cow is consuming is determined by the dry matter intake/body wt. of the cow (%). As noted, at C7 L: 50-67, Sato teaches a method of giving a cow a feed mixture diet, as found in column 8 Table 3. The specific composition of the diet, materials in the diet, are given in column 9 Table 4. Accordingly, Sato discloses determining a ruminant diet and the quantity of the diet being consumed by the ruminant.
Regarding claim 38, it is noted, “determining” is a mental step and not a tangible step that is being performed by the claim. The entirety of claim 38 is directed toward the mental step of determining and this mental step is not linked to any tangible quantity or steps required by the claim. Therefore, anything that teaches determining a diet for a ruminant, will be considered to meet the claim.
Sato teaches a method as discussed above in claim 1. Sato teaches at C7 L: 50-67, a method of determining a feed mixture diet for a cow, as found in column 8 Table 3. The specific composition of the diet or materials in the diet before the diet is altered (C7 L:50-67), are given in column 9 Table 4, and include soybean meal, corn gluten meal, and rapeseed meal or canola meal, all sources of protein.
Response to Arguments
Applicant's arguments filed 9/22/2025 have been fully considered but they are not persuasive.
Claim Rejections – 35 USC § 101
Applicant argues, on pgs. 8-9 of their remarks, that the claims do not recite a mental process but recite additional elements that integrate any alleged mental process into a practical application. Applicant argues that with the claim amendments, the 101 rejection has been overcome because claim 1 now recites, among other features, “a method of treatment for treating amino acid deficiency in ruminants.” Applicant states that the measuring steps, preparing by mixing step, and physical administration step, all achieve the therapeutic effect of reducing amino acid deficiency. Applicant argues the claims, as amended, tie any mental processes to physical inputs and output and apply it to a practical application, i.e. method steps. However, the Office disagrees for the following reasons.
Regarding applicant’s argument that the claims recite additional elements that integrate any alleged mental process into practical application, i.e. method steps, the claimed invention is directed to mental processes without significantly more. The so called “method” steps are mental process steps that include determining, predicting and comparing steps and not any physical steps to be performed. Nothing is preventing an individual, when performing the method steps, to do so by mentally calculating the amounts that need to be added to the unaltered diet of the ruminant to supplement their nutrition where it is deficient. Any data of unaltered diets and ingredients, (e.g. measurements of the unaltered diet, measured feed intake, measurements of the unaltered diet consumed by the ruminant) are considered to be part of the calculations and are data used to complete the calculations, and not physical steps. No language recitation within the claims takes the claim limitations out of the mental processes grouping.
As stated above in the 101 rejection, the claims, including the amendments and dependent claims, do not include additional elements that are sufficient to amount to significantly more than the judicial exception. A method of feeding an adjusted diet to a ruminant that contains enough amino acids to ensure that if an amino acid deficiency was being experienced by the animal that the amino acid deficiency would be remedied by eating the adjusted diet, is nothing more than normal, routine and conventional. It is normal to adjust a diet to meet dietary requirements and these are mere instructions. Additionally, it is noted that an unaltered diet could still meet the amino acids needs of the ruminant, leading to the ruminant not needing any remedy to an amino acid deficiency, since an amino acid deficiency may or may not even be present in the ruminant. Therefore, the 101 rejection is maintained as the claim limitations that are physical method steps, preparing by mixing and feeding an adjusted diet, are considered routine and conventional and are not additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim Rejections – 35 USC § 102
Applicant argues, on pgs. 9-10 of their remarks, that the amended claims reflect a method that relies on the integration of specific, measurable parameters, effective energy and energy requirement, that are not addressed in the prior art. Applicant argues that to support an anticipation rejection under 102, the reference must teach every element of the claimed invention. Applicant continues stating that Sato, fails to disclose the effective energy and effective energy requirement driven prediction-and-comparison framework or the responsive preparation step recited in the claims. Applicant argues that Sato neither discloses nor suggests a method in which the ruminant’s amino acid requirement is determined and applied through a comparison that integrates measured diet energy and an animal energy requirement. Applicant states that Sato does not anticipate the amended claims which achieve improved nutritional outcomes and feeding efficiency by utilizing measured energy parameters to drive prediction, comparison and a responsive preparation/administration regimen. The Office disagrees for the following reasons.
As stated in the above rejection, the only physical steps that are being performed in claims 1 and 33 are preparing and administering the adjusted diet, the dietary supplement, or the combination thereof to a ruminant. The method steps of predicting, comparing, and determining are all mental steps and not tangible steps that are being performed by the claim. Any utilized measured energy parameters are considered to be part of the calculations and are data used to complete the calculations, which can be done as a mental process, and not physical steps like preparing, mixing, and administering. Thus, as long as Sato teaches the positively recited and tangible method steps as recited in claim 1, which are preparing and administering a composition to a ruminant, then the claim limitations are considered to be met, and Sato is considered to teach every aspect of the claimed invention either explicitly or impliedly.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
Prosecution Insights