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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 21, 2026 has been entered.
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 1-11 and 15-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product without significantly more. The claims recite a composition comprising saponins, phenolic components and p-cimenol, which are all naturally occurring. The claimed ingredients are not different from their naturally occurring counterparts because they contribute the same nutritional or therapeutic properties as in the forms found in nature. This judicial exception is not integrated into a practical application because merely combining individual components in specific amounts or placing the combination of individual components in a non-specified material does not change their individual or therapeutic properties. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no indication that the structure or function of the individual components change when they are combined in the claimed amounts of in a non-specified material.
The amendment “for animal feed” and “formulated to reduce environmental ammonia concentration” do not add any specific components to the composition that would change the structure or function of the individual components.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 10-11 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (CN 108651737 A; Oct. 16, 2018) in view of Borrell (US 2017/0064979 A1; March 9, 2017).
Regarding claim 1, Chen discloses an additive for animal feed comprising effective amounts of saponins and phenolic components ([0012]).
While Chen teaches an additive as described above, Chen fails to teach the additive further comprising p-cimenol.
Borrell teaches an additive for use in animal feed, wherein the additive comprises an effective amount of p-cimenol ([0027]-[0028], See claims). Borrell teaches that p-cimenol provides the functions of bactericidal, fungicidal and preservative ([0011]). Borrell teaches that the additive improves the physiological state of the intestine ([0002]).
As it is well known in the art for a feed additive for animals to include p-cimenol, it would have been obvious to one of ordinary skill in the art to further have the additive of Chen comprise p-cimenol. Doing so would provide the additive of Chen with bactericidal, fungicidal and preservative properties as taught by Borrell in order to improve the physiological state of the intestine.
With respect to the additive being “formulated to reduce environmental ammonia concentration”, the examiner notes that the claims do not recite anything more than the additive comprising saponins, p-cimenol and phenolic components. Claim 1 does not recite any additional limitations on how the additive is formulated to reduce environment ammonia concentration, such as specific amounts of each component. Therefore, an additive comprising the three claimed components, saponins, p-cimenol and phenolic components, is considered to meet the claimed limitation “formulated to reduce environmental ammonia concentration”.
As the combination of the prior art as described above renders obvious the claimed additive comprising saponins, p-cimenol and phenolic components, the composition of the prior art is considered to be formulated to reduce environmental ammonia concentration.
With respect to the composition “consisting essentially of” the claimed components, the examiner notes that Chen teaches additional components in the feed additive. However, these additional components are not considered to materially affect the basic and novel characteristics of the composition as all the components are directed towards a feed additive and would continue to function predictably as such. Therefore, absent a showing that the additional components in Chen would materially change the characteristics of the claimed invention, the prior art is considered to render obvious a composition consisting essentially of the claimed components.
Regarding claim 2, Chen teaches that the phenolic compounds can be resveratrol ([0012]).
Regarding claim 3, Chen teaches that the saponins are present in an amount of 6-11 parts by weight ([0012]), or 6-11% by weight, while the claim requires an amount of 2.25% by weight.
However, it would have been obvious to one of ordinary skill in the art to vary the amount of saponins in the additive depending on the desired properties of the additive.
As stated in MPEP 2144.05: 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. "Where 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)
Therefore, absent a showing of criticality, the claimed amount is merely an obvious variant over the prior art.
Regarding claim 4, Chen teaches that the phenolic components are present in an amount of at least 4.3 parts by weight (0.3 parts resveratrol + 4 parts tea polyphenols, [0012]), or 4.3% by weight, while the claim requires an amount of 3.5% by weight.
However, it would have been obvious to one of ordinary skill in the art to vary the amount of phenolic components in the additive depending on the desired properties of the additive.
As stated in MPEP 2144.05: 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. "Where 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)
Therefore, absent a showing of criticality, the claimed amount is merely an obvious variant over the prior art.
Regarding claim 5, Borrell further teaches that an additive comprises p-cimenol in an amount of at least 3.5% by weight (Claim 19), t while the claim requires an amount of 1.6% by weight.
However, it would have been obvious to one of ordinary skill in the art to vary the amount of p-cimenol in the additive depending on the desired properties of the additive.
As stated in MPEP 2144.05: 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. "Where 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)
Therefore, absent a showing of criticality, the claimed amount is merely an obvious variant over the prior art.
Regarding claims 10-11, as stated above, Borrell teaches the use of p-cimenol in a feed additive. Borrell further teaches that the p-cimenol is extracted from Thymus vulgaris ([0027]-[0028]), wherein the extract has a p-cimenol content of 14-16% by weight ([0029]), thus overlapping the claimed range of 15-17% by weight.
Regarding claim 16, as stated above, Chen teaches that the saponins are present in an amount of 6-11 parts by weight ([0012]), or 6-11% by weight, while the claim requires an amount of about 2.25% by weight.
However, it would have been obvious to one of ordinary skill in the art to vary the amount of saponins in the additive depending on the desired properties of the additive.
As stated in MPEP 2144.05: 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. "Where 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)
Therefore, absent a showing of criticality, the claimed amount is merely an obvious variant over the prior art.
Regarding claim 17, as stated above, Chen teaches that the phenolic components are present in an amount of at least 4.3 parts by weight (0.3 parts resveratrol + 4 parts tea polyphenols, [0012]), or 4.3% by weight, while the instant claim requires an amount of about 3.5% by weight.
However, it would have been obvious to one of ordinary skill in the art to vary the amount of phenolic components in the additive depending on the desired properties of the additive.
As stated in MPEP 2144.05: 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. "Where 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)
Therefore, absent a showing of criticality, the claimed amount is merely an obvious variant over the prior art.
Regarding claim 18, as stated above, Borrell further teaches that an additive comprises p-cimenol in an amount of at least 3.5% by weight (Claim 19), while the instant claim requires an amount of about 1.6% by weight.
However, it would have been obvious to one of ordinary skill in the art to vary the amount of p-cimenol in the additive depending on the desired properties of the additive.
As stated in MPEP 2144.05: 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. "Where 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)
Therefore, absent a showing of criticality, the claimed amount is merely an obvious variant over the prior art.
Claims 6-9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (CN 108651737 A; Oct. 16, 2018) and Borrell (US 2017/0064979 A1; March 9, 2017) as applied to claim 1 above, and further in view of Calabotta et al. (US 2015/0250842 A1; Sep. 10, 2015).
Regarding claims 6-9, Chen discloses that the saponins are from yucca ([0012]), but fails to specifically teach that the saponins are contained in a concentrated stem extract of Yucca schidigera.
Calabotta discloses a feed additive comprising saponins and phenols that can be an extract of Yucca schidigera ([0005], [0016], [0097])
It would have been obvious to one of ordinary skill in the art for the saponins and phenolic compounds of Chen to be contained in a concentrated stem extract of Yucca schidigera as taught by Calabotta as Calabotta teaches that such plant extract is beneficial as a feed additive for animals and therefore would provide the same benefits to the additive of Chen.
Calabotta further teaches that the extract comprises a minimum of 15% total dissolved solids of saponins, resvertrols and other compounds ([0097]). Therefore, it would have been obvious to one of ordinary skill in the art for the extract of Yucca schidigera to comprise at least 15% by weight combined saponins and phenolic compounds. Further, it would have been obvious to one of ordinary skill in the art to process the plant in a way that provides an extract having a desired concentration of saponins and phenolic compounds. This is merely routine experimentation that is well within the ordinary skill in the art.
Regarding claim 18, as stated above, Calabotta teaches that the extract comprises a minimum of 15% total dissolved solids of saponins, resvertrols and other compounds ([0097]). Therefore, it would have been obvious to one of ordinary skill in the art for the extract of Yucca schidigera to comprise at least 15% by weight combined saponins and phenolic compounds.
With respect to the phenolic content being about 9.4% by weight, Calabotta teaches that 15% is a combined total. It would have been obvious for the concentration of phenolic compounds to be less than 15% due to the additional presence of saponins.
Further, it would have been obvious to one of ordinary skill in the art to process the plant in a way that provides an extract having a desired concentration of saponins and phenolic compounds. This is merely routine experimentation that is well within the ordinary skill in the art.
With respect to the additive being “formulated to reduce environmental ammonia concentration”, the examiner notes that the claims do not recite anything more than the additive comprising saponins, p-cimenol and phenolic components. Claim 1 does not recite any additional limitations on how the additive is formulated to reduce environment ammonia concentration, such as specific amounts of each component. Therefore, an additive comprising the three claimed components, saponins, p-cimenol and phenolic components, is considered to meet the claimed limitation “formulated to reduce environmental ammonia concentration”.
As the combination of the prior art as described above renders obvious the claimed additive comprising saponins, p-cimenol and phenolic components, the composition of the prior art is considered to be formulated to reduce environmental ammonia concentration.
Response to Arguments
Applicant’s amendments have overcome the claim objections from the previous Office Action and therefore they have been withdrawn.
Applicant’s arguments with respect to the 101 rejection have been fully considered but were not found persuasive.
Applicant argues on pages 8-10 that the claims do not merely recite the components in their natural state as the claims define a specific combination of compounds in particular concentrations, specifically formulated as an additive for animal feed and therefore the composition is not a naturally occurring composition and reflect a human-engineered formulation. Applicant states that the formulation exhibits properties not attributable to the individual components alone, such as synergistic antimicrobial and intestinal health benefits, which result in reduced environmental ammonia concentrations as demonstrated in the examples of the specification.
This is not found persuasive as applicant has not shown how the compounds are “human-engineered’ besides merely combining them in different concentrations. There is no indication that the structure or function of the individual components change when they are combined in the claimed amounts. Therefore, the claimed ingredients do not appear to be different from their naturally occurring counterparts because they contribute the same nutritional or therapeutic properties as in the forms found in nature.
Regarding the formulation exhibiting properties not attributable to the individual components alone, such as synergistic antimicrobial and intestinal health benefits, which result in reduced environmental ammonia concentrations as demonstrated in the examples of the specification, the examiner notes that the examples in the specification do not report actual amounts for each compound that would provide these alleged synergistic results. Paragraph [0075] discloses a “guaranteed minimum” concentration, however, there appears to be no actual amounts of the components. Further, to show such synergistic results, the examples do not provide what amount of each compound is needed. Does any concentration of the three claimed components provide the synergistic benefits? The controls in the examples in the specification appear to have no supplements at all. Therefore, it is not clear how the claimed components are combined in a way that would allow them to function differently than their naturally occurring counterparts.
The amendment “for animal feed” and “formulated to reduce environmental ammonia concentration” do not add any specific components to the composition that would change the structure or function of the individual components. Therefore, applicant’s arguments are not found persuasive as the claim amendments do not add anything or provide concentrations that are way outside what would have been found in nature, absent a showing otherwise.
The amendment “for animal feed” is merely an intended use of the additive as it is not actually combined with a feed composition. Again, the amendments do not add anything to the composition that would make the composition outside of what would have been found in nature.
Claim 1 recites nature-based product limitaitons. e.g., effective amounts of saponins, phenolic components and p-cimenol. Although the specifi mixture of ingredients recited does not occur in nature, each ingredient is individually a naturally occurring ingredient, such that the subject matter of claim 1 is similar to that of the subject matter at issue in Funk Brothers. See Funk Bros., 333 U.S. at 129-132 (considering a mixture of bacteria). Applicant has not provided any findings showing that the individual components are different than their naturally occurring counterparts and that they contribute different nutritional and therapeutic properties. Nor has applicant provided any basis that the structure of function of the individual components changes when they are combined in the claimed amounts.
Therefore, applicant’s arguments with respect to the 101 rejection are not found persuasive.
Applicant’s arguments with respect to the 103 rejection have been fully considered but were not found persuasive.
Applicant argues there is not motivation to combine the compositions of Chen and Borrell. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, both Chen and Borrell are directed towards additives for animal feed that provide benefits to the animals. Therefore, combining Chen with Borrel, or adding p-cimenol disclosed in Borrell to the additive of Chen would have been obvious as it is well known in the art to be useful as an additive in animal feed and further provides benefits. Borrell teaches that p-cimenol provides the functions of bactericidal, fungicidal and preservative ([0011]). Borrell teaches that the additive improves the physiological state of the intestine ([0002]). Therefore, combining known teachings to provide an additive as claimed would have been obvious based upon the suggestion of the prior art.
Further, 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)
As stated in MPEP 2144.06 ““It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.)”
With respect to applicant’s argument that the prior art fails to teach or suggest that the claimed combination would yield the synergistic antimicrobial and gut health benefits, or the reduction of environmental ammonia concentration, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding applicant’s argument that the prior art fails to teach the claimed amounts. The examiner notes that applicant has not show criticality for the claimed amounts and therefore they are merely obvious variants over the prior art.
As stated in MPEP 2144.05: 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. "Where 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)
Therefore, absent a showing of criticality, the claimed amount is merely an obvious variant over the prior art.
Regarding applicant’s argument that the formulation exhibits properties not attributable to the individual components alone, such as synergistic antimicrobial and intestinal health benefits, which result in reduced environmental ammonia concentrations as demonstrated in the examples of the specification, the examiner notes that the examples in the specification do not report actual amounts for each compound that would provide these alleged synergistic results. Paragraph [0075] discloses a “guaranteed minimum” concentration, however, there appears to be no disclosure of actual amounts of the components. Further, to show such synergistic results, the examples do not provide what amount of each compound is needed. Does any concentration of the three claimed components provide the synergistic benefits? The controls in the examples in the specification appear to have no supplements at all. Therefore, it is not clear how the claimed components in the claimed amounts produce unexpected results. The examples in the specification merely recite a “guaranteed minimum” required for each component and further recite how much of the composition is added to feed, but does not specifically recite the amounts of each component that make up the composition added to the feed. Therefore, applicant’s arguments are not commensurate in scope with the claims.
Further, with respect to the composition “consisting essentially of” the claimed components, the examiner notes that Chen teaches additional components in the feed additive. However, these additional components are not considered to materially affect the basic and novel characteristics of the composition as all the components are directed towards a feed additive and would continue to function predictably as such. Therefore, absent a showing that the additional components in Chen would materially change the characteristics of the claimed invention, the prior art is considered to render obvious a composition consisting essentially of the claimed components.
For the reasons stated above, the 101 and 103 rejections are maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE A KOHLER whose telephone number is (571)270-1075. The examiner can normally be reached Monday-Friday 8am-5pm.
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/STEPHANIE A KOHLER/Primary Examiner, Art Unit 1791