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 Application
Receipt of the Response and Amendment after Non-Final Office Action filed 13 April 2026 and the Supplemental Response and Amendment filed on 27 April 2026 is acknowledged.
Applicant has overcome the following by virtue of amendment of the claims: (1) the objection to the claim 20 has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-3, 7-12, and 16-23
Withdrawn claims: None
Previously canceled claims: 4-6 and 13-14
Newly canceled claims: 15
Amended claims: 1 and 20
New claims: 21-23
Claims currently under consideration: 1-3, 7-12, and 16-23
Currently rejected claims: 1-3, 7-12, and 16-23
Allowed claims: None
Claim Objections
Applicant is advised that should claim 1 be found allowable, claims 2 and 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
MPEP § 1824 states, “Claims must be clear and concise”. Claims 1 and 20 are objected to because of the following informalities:
Claim 1 lacks conciseness due to unnecessary repetition of elements. Claim 1 may be made more concise by instead reciting, “…delivering a polyphenol source to the lower gastrointestinal tract of the companion animal by administering an effective amount of a controlled release pet food composition, wherein the controlled release pet food composition comprises: a controlled release matrix comprising: a fiber component comprising a high solubility fiber source and a low solubility fiber source, wherein the fiber component comprises a combination of from about 2.5 to about 8 wt.% of pecan shells, from about 2 to about 4 wt.% of flax seed, from about 2 to about 3 wt.% of citrus pulp, from about 2 to about 3 wt.% of beet pulp, and from about 0.5 to about 1.5 wt.% of cranberry pomace; and a polyphenol source comprising one or more of the cranberry pomace, pomegranate extract, or green tea extract…”
Claim 20 lacks conciseness due to unnecessary repetition of elements. Claim 20 may be made more concise by instead reciting, “…delivering a polyphenol source to the lower gastrointestinal tract of the companion animal suffering from the inflammatory bowel disease by administering an effective amount of a controlled release pet food composition, the controlled release pet food composition comprising: fish oil and a controlled release matrix comprising: a fiber component comprising a high solubility fiber source, a low solubility fiber source, and an inert, non-fermentable fiber source, wherein the fiber component comprises a combination of about 7 wt.% of pecan shells, about 3 wt.% of flax seed, about 2.5 wt.% of citrus pulp, about 2.5 wt.% of beet pulp, and about 1 wt.% of cranberry pomace; and a polyphenol source comprising the cranberry pomace and optionally one or more of pomegranate extract, or green tea extract…”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-3, 7-12, 16-19, and 21-22 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 regards as the invention.
Claim 1 recites the limitation “the pomegranate extract, or the green tea extract” in lines 14-15. There is insufficient antecedent basis for this limitation in the claim. Applicant may overcome this rejection by instead reciting “pomegranate extract, or green tea extract” or omitting these elements.
Claims 2-3, 7-12, 16-19, and 21-22 are rejected due to their dependency from claim 1.
Claim Rejections - 35 USC § 103
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 1-3, 12, 16-18, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Altom et al. (US 2007/0202154 A1, cited on the IDS filed on 27 October 2022) in view of Perth Cat Hospital (Perth Cat Hospital. (2015, December 23). Chronic Intestinal Disease in Cats. Retrieved December 15, 2025, from https://web.archive.org/web/20191023200544/ http://www.perthcathospital.com.au/chronic-intestinal-disease-cats/), Capodieci (US 2010/0040745 A1), Yamka et al. (US 8057828 B2, cited on the IDS filed on 27 October 2022), and Xu et al. (US 8691792 B2, cited on the IDS filed on 27 October 2022), and as evidenced by Kureck et al. (Kureck, I., de Brito Policarpi, P., Toaldo, I. M., et al. (2018). Chemical Characterization and Release of Polyphenols from Pecan Nut Shell [Carya illinoinensis (Wangenh) C. Koch] in Zein Microparticles for Bioactive Applications. Plant Food Hum Nutr, 73, 137-145. https://doi.org/10.1007/s11130-018-0667-0), Perlman et al. (US 2008/0044539 A1, cited on IDS filed on 27 October 2022), and Quirós-Sauceda et al. (Quirós-Sauceda, A. E., Palafox-Carlos, H., Sáyago-Ayerdi, S. G., et al. (2014). Dietary fiber and phenolic compounds as functional ingredients: interaction and possible effect after ingestion. Food Funct, 5, 1063-1072. http://doi.org/ 10.1039/c4fo00073k).
Regarding claims 1-2 and 16, Altom teaches a method comprising: delivering a polyphenol source to the lower gastrointestinal tract of a companion animal by administering an effective amount of a controlled release pet food composition – Altom teaches a process of feeding to at least a dog or cat (i.e., companion animal) ([0018]) a food ([0019]) containing soluble ([0041], “fermentable”) and insoluble fiber ([0032], “nut shell”), to promote gastrointestinal health and the overall health of the pet ([0010]-[0011], [0014]). Altom further teaches that the process of feeding an animal an animal food comprising a nut shell aids in gastric and intestinal passage of ingested hair by trapping or binding ingested hair, increasing gastric emptying and allowing the ingested hair to pass out through the feces more frequently, thereby reducing the chronic formation of hairballs ([0031]).
Regarding delivering a polyphenol to the lower gastrointestinal tract of the companion animal, Kureck evidences that “pecan nut shells are characterized by higher amounts of polyphenols than the nuts” (p. 138, col. 1, ¶ 1). Therefore, where Altom discloses that the animal food comprising a nut shell, which may be pecan nut shell ([0036]), aids in gastric and intestinal passage of ingested hair by trapping or binding ingested hair, increasing gastric emptying and allowing the ingested hair to pass out through the feces more frequently ([0031]), Altom discloses that the polyphenol source (i.e., pecan nut shell) is delivered to the lower gastrointestinal tract of the animal.
Regarding the claimed “effective amount”, Altom discloses that “administration may be continuous or intermittent, depending, for example, upon the recipient’s physiological condition, whether the purpose of the administration is therapeutic or prophylactic, and other factors known to skilled practitioners ([0030]). Therefore, Altom discloses administering an effective amount of the pet food composition to have a therapeutic or prophylactic effect.
Altom does not explicitly discuss that the method is a method for ameliorating a symptom of an inflammatory bowel disease in a companion animal.
However, Perth Cat Hospital teaches, “A significant number of cats that vomit hairballs have underlying stomach and intestinal disease. IBD and lymphoma often lead to a motility disorder of the gastrointestinal tract. The thickened stomach wall and intestinal loops are unable to move hair through the digestive tract at its normal speed. This slower movement results in abnormal hair collection in the stomach or intestines, resulting in hairball formation.” (p. 3, ¶ 9). Therefore, Perth Cat Hospital teaches that frequent hairballs are a symptom of IBD.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to administer the animal food of Altom to a companion animal to ameliorate a symptom of an inflammatory disease (i.e., IBD) in the companion animal in need thereof. Where Altom teaches administering the animal food to an animal to decrease chronic formation of hairballs ([0031]), and where Perth Cat Hospital teaches that frequent (i.e., chronic) hairballs are a symptom of IBD, one of ordinary skill in the art would have been motivated to administer the food of Altom to an animal with IBD experiencing chronic hairballs. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Altom teaches that the nut shells and supplemental fibers of the animal food aid in gastric and intestinal passage of ingested hair and their subsequent excretion, thereby decreasing chronic formation of hairballs ([0031]), thus ameliorating a symptom of IBD.
wherein the controlled release pet food composition comprises: a controlled release matrix comprising:
a fiber component comprising a high solubility fiber source and a low solubility fiber source – Altom teaches that the pet food comprises soluble ([0041], “fermentable”) and insoluble fiber ([0032], “nut shell”). It is noted that the instant specification at paragraph [0019] states, “In some embodiments, the terms "high solubility fiber" and "soluble fiber" may be used interchangeably. In some embodiments, the terms "low solubility fiber" and "insoluble fiber" may be used interchangeably.” Accordingly, this limitation is met by Altom. Additionally, regarding insoluble and soluble fibers, Altom teaches that feeding cats large amounts of supplemental indigestible/non-fermentable/insoluble fiber can reduce the formation and occurrence of hairballs, but can result in side effects such as constipation, excessive stool output, decreased nutrient digestibility, and inferior coat appearance ([0007]), and that feeding high amounts of fermentable/gelling/soluble fibers to induce satiety, improve glucose homeostasis, and delay gastric emptying can cause side effects including loose and/or watery stools, nausea, and vomiting ([0009]). Therefore, Altom teaches that insoluble and soluble fiber are result-effective variables in an animal food composition.
wherein the fiber component comprises a combination of from about 2.5 to about 8 wt.% of pecan shells, from about 2 to about 4 wt.% of flax seed, from about 2 to about 3 wt.% of citrus pulp, from about 2 to about 3 wt.% of beet pulp, and from about 0.5 to about 1.5 wt.% of cranberry pomace – Altom also teaches the animal food comprising from about 0.5% to about 10% by weight of pecan nut shell ([0038]), which encompasses and thereby renders obvious the claimed about 2.5 to about 8 wt.% of pecan nut shell, see MPEP 2144.05(I). Altom further teaches citrus pulp and beet pulp as supplemental fiber sources ([0046]), and teaches that the total supplemental fiber source is present from about 5%-20% by weight of the animal food ([0043]). Specific dry food examples in Altom teach animal food comprising 1.0 and 3.0 % by weight beet pulp and 5.0 % by weight pecan shell (p. 6, Examples 2, 4 and 6). The disclosure of 1.0 and 3.0 % by weight beet pulp teaches a range of 1.0 to 3.0 weight % beet pulp, which encompasses and thereby renders obvious the claimed about 2 to about 3 wt.%, see MPEP 2144.05(I).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the citrus pulp and beet pulp in amounts as claimed, as the total of the amounts for additional fiber claimed is consistent with the amounts taught by Altom, and the claimed amounts would have been achievable by no more than routine experimentation, see MPEP § 2144.05(II)(A). Furthermore, Altom provides motivation to adjust the amount of supplemental fiber to promote intestinal health and modulate intestinal bacteria ([0041]).
Altom does not discuss that the animal food comprises flax seed.
However, Altom teaches various other types supplemental fibers ([0046] – [0047]), and Yamka teaches flax seed as a source of fiber known to be included in pet foods, along with citrus pulp, beet pulp, and cranberry (col. 7, lines 1-15).
Therefore, since Altom teaches several types of supplemental fibers ([0046] – [0047]) in addition to citrus pulp and beet pulp, and that the total supplemental fiber source is present from about 5%-20% by weight of the animal food ([0043]), it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Altom with the teachings of Yamka to substitute flax seed for one of the additional supplemental fiber sources to provide the total supplemental fiber in an amount falling within the claimed range and where the total of beet pulp, citrus pulp, and flax seed is within the range taught by Altom, including the claimed amount of about 2 to about 4 wt.% of flax seed. See MPEP § 2143(I)(B). Furthermore, MPEP § 2144.07 states, “The selection of a known material based on its suitability for its intended use support[s] a prima facie obviousness determination”. Since Yamka discloses that the claimed flax seed is a suitable fiber source for use in combination with citrus pulp, beet pulp, and cranberry, each of which is disclosed by Altom, it would have been prima facie obvious to select flax seed as an additional supplemental fiber component for the animal feed of Altom.
Regarding the cranberry pomace, the examples of Capodieci teach cranberry pomace as a source of fiber in pet food at amounts of 0, 1.82, and 2.00 % by weight of the pet food (p. 5, SWP Formula 1, p. 10, SWP Formula 7, and p. 6, SWP Formula 2, respectively). As an optional component in the prior art Capodieci teaches cranberry pomace in a range of 0-2.00 % by weight. The range of 0-2.00% by weight of cranberry pomace encompasses and renders obvious the claimed amount of about 0.5 to about 1.5 wt.% of cranberry pomace, see MPEP § 2144.05(I). Since Capodieci teaches the cranberry pomace provides fiber, and since Altom teaches that the animal food may comprise cranberries ([0063]), which include the cranberry pomace, as well as that insoluble and soluble fibers are result-effective variables (as established from paragraphs [0007] and [0009] as discussed hereinabove), the adjustment of the amounts of fiber in the pet food ([0038], [0043]) and speaks to the effects imparted by both the insoluble and soluble fibers ([0032], [0041]), it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to adjust the amount of the fiber sources to have arrived at amounts as claimed through no more than routine experimentation, see MPEP § 2144.05(II)(A). Furthermore, given that the claimed components are taught in the prior art as sources of fiber known to be included in pet foods, the claimed amounts are not considered to represent an unobvious contribution over the prior art.
a polyphenol source comprising one or more of the cranberry pomace, pomegranate extract, or green tea extract – Altom teaches that the animal food may comprise antioxidants ([0058]) and may comprise cranberries ([0063]). Altom does not specifically discuss cranberry pomace as a polyphenol source or the source of the antioxidants. As evidenced by Perlman, cranberry pomace is a source of polyphenolic antioxidants ([0096]).
Where Altom as modified by Perth Cat Hospital, Yamka, and Capodieci renders obvious cranberry pomace as a fiber source, and where Perlman provides evidence that cranberry pomace is also a source of polyphenolic antioxidants, the claimed polyphenol source limitation has been met.
wherein the fiber component comprises a weight ratio of the high solubility fiber source to the low solubility fiber source of about 1:15 to about 1:2 – Altom teaches the nut shell (i.e., insoluble fiber) is present at up to 20 or 30 or 50% by weight of the pet food composition ([0038]), while the supplemental fiber, which includes the soluble fiber, is present from about 5-20% by weight of the pet food ([0043]). Altom further teaches that insoluble and soluble fibers are result-effective variables (as established from paragraphs [0007] and [0009] as discussed hereinabove). These amounts for ranges constitute amounts that render the claimed ratio obvious. For example, 5% by weight of soluble fiber : 50% by weight of insoluble fiber is a ratio of 1:10. Furthermore, Altom speaks to the effects imparted by both the insoluble and soluble fibers ([0032], [0041]). MPEP § 2144.05(II)(A) states, “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 of percentage ranges is the optimum combination of percentages.” As such, it would have been obvious for one of ordinary skill in the art to adjust the amount of the fiber sources and arrive at ratios of about 1:15 to about 1:2 as claimed through no more than routine experimentation.
Additionally, Xu teaches compositions suitable for maintaining or improving the gastrointestinal health of an animal, including improving stool quality, wherein the total dietary fiber of the compositions contains from about 10 to about 40% soluble fiber and from about 90 to about 60% insoluble fiber (Abstract). Xu teaches that any soluble fiber (col. 4, lines 17-25) and any insoluble fiber suitable for consumption by an animal can be used (col. 4, lines 26-33).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Altom with the teachings of Xu to include a ratio of the high solubility fiber source to the low solubility fiber source of about 10:90 to about 40:60 (i.e., about 1:9 to about 1:1.3). The claimed range overlaps the disclosed range. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I). One of ordinary skill in the art would have been motivated to do so because Altom speaks to the need to balance the amount of insoluble and soluble fibers in an animal food to reduce hairball occurrence while minimizing side effects, and Xu teaches that a ratio of soluble to insoluble fiber of about 1:9 to about 1:1.3 maintains or improves the gastrointestinal health of an animal. Xu shows, that:
1) it was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select the claimed range when making compositions to improve the gastrointestinal health of an animal, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use (see MPEP § 2144.07); and
2) there are advantages to doing such a thing, including maintaining or improving the gastrointestinal health of an animal, which is an objective of Altom ([0010]), which shows a recognition in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that beneficial result would have been produced by their combination (see MPEP § 2144(II) that states, “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination”).
One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because the claimed ratio of about 1:9 to about 1:1.3 substantially overlaps the claimed range of about 1:15 to 1:2.
wherein the controlled release matrix comprises an inert, non-fermentable fiber source having polyphenols chemically or physically bound thereto, such that the controlled release matrix is adapted to deliver the polyphenol source to the lower gastrointestinal tract of the companion animal after ingestion by the companion animal – As described above, Altom teaches an animal food comprising pecan shells as insoluble (i.e., inert, non-fermentable) fiber ([0032]), and Kureck evidences that “pecan nut shells are characterized by higher amounts of polyphenols than the nuts” (p. 138, col. 1, ¶ 1). Altom as modified by Perth Cat Hospital, Yamka, Capodeici, and Xu teaches cranberry pomace as a source of insoluble fiber (as the fraction of total fiber that is not soluble fiber) (Capodieci, p. 6, SWP Formula 2, Total Fiber 75.30%, Soluble Fiber 4.5%) comprising polyphenol antioxidants (as evidenced by Perlman, [0096]). As evidenced by Quirós-Sauceda, phenolic compounds are ubiquitous in fruits and nuts (p. 1064, col. 2, ¶ 1), and phenolic compounds are chemically associated, or linked, to dietary fiber in the fruit matrix forming “antioxidant dietary fiber” (p. 1064, col. 2, ¶ 3; p. 1065, Fig. 1). Additionally, Altom discloses that the animal food comprising a nut shell aids in gastric and intestinal passage of ingested hair by trapping or binding ingested hair, increasing gastric emptying and allowing the ingested hair to pass out through the feces more frequently ([0031]). Finally, the instant specification provides, “The composition is produced by extrusion, dried, and then coated with a palatant. The process used to manufacture the composition described in Table 8 (below), ensures the creation of the inventive matrix of present invention.” ([0052]). Altom teaches that dry animal food compositions are made by mixing the ingredients, extruding the mixture into kibbles, and drying the kibbles ([0085]).
Where this combination of references discloses the same ingredients as in the claimed matrix, where Quirós-Sauceda provides evidence that polyphenols are chemically linked to dietary fiber, where Altom discloses delivery of the nut shell/insoluble fiber through the digestive tract, where the dry animal food of Altom is produced by extrusion and drying, and the instant specification provides that such a method ensures the creation of the inventive matrix, the limitation of a “controlled release matrix comprising an inert, non-fermentable fiber source having polyphenols chemically or physically bound thereto, such that the controlled release matrix is adapted to deliver the polyphenol source to the lower gastrointestinal tract of the companion animal after ingestion by the companion animal” has been met by the prior art. The limitation of a “controlled release pet food composition” is likewise met.
wherein the controlled release matrix, upon delivery to the lower gastrointestinal tract, produces elevated serum levels of microbial post-biotics through microbial metabolism of the fiber-bound polyphenols –
Altom as modified by Perth Cat Hospital, Yamka, Capodieci, and Xu discloses using the claimed method step of delivering a polyphenol source to the lower gastrointestinal tract of the companion animal by administering an effective amount of a controlled release pet food composition including all claimed limitations. When the method steps recited in the prior art reference are substantially identical to those of the claims, claimed properties of the resulting composition are presumed to be present in the composition of the prior art. The burden of proof shifts to the applicant to provide objective evidence (i.e., test data) to the contrary. See In re Best, 562, F.2d 1252, 1254, 195 USPQ 403, 433 (CCPA 1977). MPEP § 2112.01(I). In the present case, where the cited prior art teaches the same method step using the same composition, the claimed feature of the controlled release matrix, upon delivery to the lower gastrointestinal tract, producing elevated serum levels of microbial post-biotics through microbial metabolism of the fiber-bound polyphenols is expected to occur as a result of carrying out the method step.
For these reasons, claims 1-2 and 16 are rendered obvious.
Regarding claim 3, Altom, Perth Cat Hospital, Capodieci, Yamka, and Xu teach the method of claim 1.
Altom does not discuss that the high solubility fiber source comprises oat bran.
However, Xu teaches compositions suitable for maintaining or improving the gastrointestinal heath of an animal, wherein the total dietary fiber of the compositions contains from about 10 to about 40% soluble fiber and from about 90 to about 60% insoluble fiber. Xu teaches that any soluble fiber suitable for consumption by an animal can be used, and that preferred soluble fibers include oat bran (col. 4, lines 17-25).
MPEP § 2144.07 states, “The selection of a known material based on its suitability for its intended use support[s] a prima facie obviousness determination”. Since Xu discloses that the claimed oat bran is a suitable soluble fiber for use in a food composition suitable for maintaining or improving the gastrointestinal health of an animal, it would have been prima facie obvious to use oat bran as a soluble fiber in the animal food of Altom, which is also suitable to promote the gastrointestinal health of the pet ([0010]).
Claim 3 is therefore rendered obvious.
Regarding claims 12 and 21, Altom also teaches that the pet food composition further comprises docosahexaenoate fish oil in an amount from about 0.5 to about 2.5 wt.% (re: claim 12) and, as such, fish oil (re: claim 21) – “The animal food composition may contain other active agents such as long chain fatty acids…Fish oils are a suitable source of…docosahexaenoic acid (DHA). The DHA level is at least about 0.05%, alternatively at least about…0.15% of the animal food composition, all on a dry matter basis.” ([0064]). The claimed range of about 0.5 to about 2.5 wt. % lies inside the disclosed range of at least about 0.15%. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
Claims 12 and 21 are therefore rendered obvious.
Regarding claims 17-18, Altom also teaches the animal food comprising from about 0.5% to about 10% by weight of pecan nut shell ([0038]), which encompasses and thereby renders obvious the claimed ranges of pecan nut shell, see MPEP 2144.05(I). Altom further teaches citrus pulp and beet pulp as supplemental fiber sources ([0046]), and teaches that the total supplemental fiber source is present from about 5%-20% by weight of the animal food ([0043]). Specific dry food examples in Altom teach animal food comprising 1.0 and 3.0 % by weight beet pulp and 5.0 % by weight pecan shell (p. 6, Examples 2, 4 and 6). The disclosure of 1.0 and 3.0 % by weight beet pulp teaches a range of 1.0 to 3.0 weight % beet pulp, which encompasses and thereby renders obvious the claimed about 1.25 wt.% and about 2.5 wt.%, see MPEP 2144.05(I).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the citrus pulp and beet pulp in amounts as claimed, as the total of the amounts for additional fiber claimed is consistent with the amounts taught by Altom, and the claimed amounts would have been achievable by no more than routine experimentation, see MPEP § 2144.05(II)(A). Furthermore, Altom provides motivation to adjust the amount of supplemental fiber to promote intestinal health and modulate intestinal bacteria ([0041]).
Altom does not discuss that the animal food comprises flax seed.
However, Altom teaches various other types supplemental fibers ([0046] – [0047]), and Yamka teaches flax seed as a source of fiber known to be included in pet foods, along with citrus pulp, beet pulp, and cranberry (col. 7, lines 1-15).
Therefore, since Altom teaches several types of supplemental fibers ([0046] – [0047]) in addition to citrus pulp and beet pulp, and that the total supplemental fiber source is present from about 5%-20% by weight of the animal food ([0043]), it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Altom with the teachings of Yamka to substitute flax seed for one of the additional supplemental fiber sources to provide the total supplemental fiber in an amount falling within the claimed range and where the total of beet pulp, citrus pulp, and flax seed is within the range taught by Altom, including the claimed amount of about 1.5 wt.% and about 3 wt.% of flax seed. See MPEP § 2143(I)(B). Furthermore, MPEP § 2144.07 states, “The selection of a known material based on its suitability for its intended use support[s] a prima facie obviousness determination”. Since Yamka discloses that the claimed flax seed is a suitable fiber source for use in combination with citrus pulp, beet pulp, and cranberry, each of which is disclosed by Altom, it would have been prima facie obvious to select flax seed as an additional supplemental fiber component for the animal feed of Altom.
Regarding the cranberry pomace, the examples of Capodieci teach cranberry pomace as a source of fiber in pet food at amounts of 0, 1.82, and 2.00 % by weight of the pet food (p. 5, SWP Formula 1, p. 10, SWP Formula 7, and p. 6, SWP Formula 2, respectively). As an optional component in the prior art Capodieci teaches cranberry pomace in a range of 0-2.00 % by weight. The range of 0-2.00% by weight of cranberry pomace encompasses and renders obvious the claimed amount of about 0.5 and about 1 wt.% of cranberry pomace, see MPEP § 2144.05(I). Since Capodieci teaches the cranberry pomace provides fiber, and since Altom teaches that the animal food may comprise cranberries ([0063]), which include the cranberry pomace, as well as that insoluble and soluble fibers are result-effective variables (as established from paragraphs [0007] and [0009] as discussed hereinabove), the adjustment of the amounts of fiber in the pet food ([0038], [0043]) and speaks to the effects imparted by both the insoluble and soluble fibers ([0032], [0041]), it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to adjust the amount of the fiber sources to have arrived at amounts as claimed through no more than routine experimentation, see MPEP § 2144.05(II)(A). Furthermore, given that the components in clams 17-18 are taught in the prior art as sources of fiber known to be included in pet foods, the claimed amounts are not considered to represent an unobvious contribution over the prior art.
Regarding claim 20, Altom teaches a method comprising: delivering a polyphenol source to the lower gastrointestinal tract of a companion animal by administering an effective amount of a controlled release pet food composition – Altom teaches a process of feeding to at least a dog or cat (i.e., companion animal) ([0018]) a food ([0019]) containing soluble ([0041], “fermentable”) and insoluble fiber ([0032], “nut shell”), to promote gastrointestinal health and the overall health of the pet ([0010]-[0011], [0014]). Altom further teaches that the process of feeding an animal an animal food comprising a nut shell aids in gastric and intestinal passage of ingested hair by trapping or binding ingested hair, increasing gastric emptying and allowing the ingested hair to pass out through the feces more frequently, thereby reducing the chronic formation of hairballs ([0031]).
Regarding delivering a polyphenol to the lower gastrointestinal tract of the companion animal, Kureck evidences that “pecan nut shells are characterized by higher amounts of polyphenols than the nuts” (p. 138, col. 1, ¶ 1). Therefore, where Altom discloses that the animal food comprising a nut shell, which may be pecan nut shell ([0036]), aids in gastric and intestinal passage of ingested hair by trapping or binding ingested hair, increasing gastric emptying and allowing the ingested hair to pass out through the feces more frequently ([0031]), Altom discloses that the polyphenol source (i.e., pecan nut shell) is delivered to the lower gastrointestinal tract of the animal.
Regarding the claimed “effective amount”, Altom discloses that “administration may be continuous or intermittent, depending, for example, upon the recipient’s physiological condition, whether the purpose of the administration is therapeutic or prophylactic, and other factors known to skilled practitioners ([0030]). Therefore, Altom discloses administering an effective amount of the pet food composition to have a therapeutic or prophylactic effect.
Altom does not explicitly discuss that the method is a method for ameliorating a symptom of an inflammatory bowel disease in a companion animal in a companion animal suffering from inflammatory bowel disease.
However, Perth Cat Hospital teaches, “A significant number of cats that vomit hairballs have underlying stomach and intestinal disease. IBD and lymphoma often lead to a motility disorder of the gastrointestinal tract. The thickened stomach wall and intestinal loops are unable to move hair through the digestive tract at its normal speed. This slower movement results in abnormal hair collection in the stomach or intestines, resulting in hairball formation.” (p. 3, ¶ 9). Therefore, Perth Cat Hospital teaches that frequent hairballs are a symptom of IBD.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to administer the animal food of Altom to a companion animal to ameliorate a symptom of an inflammatory disease (i.e., IBD) in the companion animal in need thereof. Where Altom teaches administering the animal food to an animal to decrease chronic formation of hairballs ([0031]), and where Perth Cat Hospital teaches that frequent (i.e., chronic) hairballs are a symptom of IBD, one of ordinary skill in the art would have been motivated to administer the food of Altom to an animal with IBD experiencing chronic hairballs. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Altom teaches that the nut shells and supplemental fibers of the animal food aid in gastric and intestinal passage of ingested hair and their subsequent excretion, thereby decreasing chronic formation of hairballs ([0031]), thus ameliorating a symptom of IBD.
the controlled release pet food composition comprising:
fish oil- – Altom teaches, “The animal food composition may contain other active agents such as long chain fatty acids…Fish oils are a suitable source of…docosahexaenoic acid (DHA). The DHA level is at least about 0.05%, alternatively at least about…0.15% of the animal food composition, all on a dry matter basis.” ([0064]). Altom therefore teaches that the animal food comprises fish oil.
and a controlled release matrix comprising:
a fiber component comprising a high solubility fiber source, a low solubility fiber source, and an inert, non-fermentable fiber source – Altom teaches that the pet food comprises soluble ([0041], “fermentable”) and insoluble fiber ([0032], “nut shell”). It is noted that the instant specification at paragraph [0019] states, “In some embodiments, the terms "high solubility fiber" and "soluble fiber" may be used interchangeably. In some embodiments, the terms "low solubility fiber" and "insoluble fiber" may be used interchangeably.” Altom teaches an animal food comprising pecan shells as insoluble (i.e., inert, non-fermentable) fiber ([0032]), as well as other nut shells, including those from walnut, filbert nut, hickory nut, hazelnut, chestnut, and combinations thereof ([0036]). Accordingly, this limitation is met by Altom. Additionally, regarding insoluble and soluble fibers, Altom teaches that feeding cats large amounts of supplemental indigestible/non-fermentable/insoluble fiber can reduce the formation and occurrence of hairballs, but can result in side effects such as constipation, excessive stool output, decreased nutrient digestibility, and inferior coat appearance ([0007]), and that feeding high amounts of fermentable/gelling/soluble fibers to induce satiety, improve glucose homeostasis, and delay gastric emptying can cause side effects including loose and/or watery stools, nausea, and vomiting ([0009]). Therefore, Altom teaches that insoluble and soluble fiber are result-effective variables in an animal food composition.
wherein the fiber component comprises a combination of about 7 wt.% of pecan shells, about 3 wt.% of flax seed, about 2.5 wt.% of citrus pulp, about 2.5 wt.% of beet pulp, and about 1 wt.% of cranberry pomace – Altom also teaches the animal food comprising from about 0.5% to about 10% by weight of pecan nut shell ([0038]), which encompasses and thereby renders obvious the claimed about 7 wt.% of pecan nut shell, see MPEP 2144.05(I). Altom further teaches citrus pulp and beet pulp as supplemental fiber sources ([0046]), and teaches that the total supplemental fiber source is present from about 5%-20% by weight of the animal food ([0043]). Specific dry food examples in Altom teach animal food comprising 1.0 and 3.0 % by weight beet pulp and 5.0 % by weight pecan shell (p. 6, Examples 2, 4 and 6). The disclosure of 1.0 and 3.0 % by weight beet pulp teaches a range of 1.0 to 3.0 weight % beet pulp, which encompasses and thereby renders obvious the claimed about 2.5 wt.%, see MPEP 2144.05(I).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the citrus pulp and beet pulp in amounts as claimed, as the total of the amounts for additional fiber claimed is consistent with the amounts taught by Altom, and the claimed amounts would have been achievable by no more than routine experimentation, see MPEP § 2144.05(II)(A). Furthermore, Altom provides motivation to adjust the amount of supplemental fiber to promote intestinal health and modulate intestinal bacteria ([0041]).
Altom does not each that the animal food comprises flax seed.
However, Altom teaches various other types supplemental fibers ([0046] – [0047]), and Yamka teaches flax seed as a source of fiber known to be included in pet foods, along with citrus pulp, beet pulp, and cranberry (col. 7, lines 1-15).
Therefore, since Altom teaches several types of supplemental fibers ([0046] – [0047]), in addition to citrus pulp and beet pulp, and that the total supplemental fiber source is present from about 5%-20% by weight of the animal food ([0043]), it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Altom with the teachings of Yamka to substitute flax seed for one of the additional supplemental fiber sources to provide the total supplemental fiber in an amount falling within the claimed range and where the total of beet pulp, citrus pulp, and flax seed is within the range taught by Altom, including the claimed amount of about 3 wt.% of flax seed. See MPEP § 2143(I)(B). Furthermore, MPEP § 2144.07 states, “The selection of a known material based on its suitability for its intended use support[s] a prima facie obviousness determination”. Since Yamka discloses that the claimed flax seed is a suitable fiber source for use in combination with citrus pulp, beet pulp, and cranberry, each of which is disclosed by Altom, it would have been prima facie obvious to select flax seed as an additional supplemental fiber component for the animal feed of Altom.
Regarding the cranberry pomace, the examples of Capodieci teach cranberry pomace as a source of fiber in pet food at amounts of 0, 1.82, and 2.00 % by weight of the pet food (p. 5, SWP Formula 1, p. 10, SWP Formula 7, and p. 6, SWP Formula 2, respectively). As an optional component in the prior art Capodieci teaches cranberry pomace in a range of 0-2.00 % by weight. The range of 0-2.00% by weight of cranberry pomace encompasses and renders obvious the claimed amount of about 1 wt.% of cranberry pomace, see MPEP § 2144.05(I). Since Capodieci teaches the cranberry pomace provides fiber, and since Altom teaches that the animal food may comprise cranberries ([0063]), which include the cranberry pomace, as well as that insoluble and soluble fibers are result-effective variables (as established from paragraphs [0007] and [0009] as discussed hereinabove), the adjustment of the amounts of fiber in the pet food ([0038], [0043]), and speaks to the effects imparted by both the insoluble and soluble fibers ([0032], [0041]), it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to adjust the amount of the fiber sources to have arrived at amounts as claimed through no more than routine experimentation, see MPEP § 2144.05(II)(A). Furthermore, given that the claimed components are taught in the prior art as sources of fiber known to be included in pet foods, the claimed amounts are not considered to represent an unobvious contribution over the prior art. The limitation of the fiber component is therefore obvious.
and a polyphenol source comprising the cranberry pomace and optionally one or more of pomegranate extract, or green tea extract – Altom teaches that the animal food may comprise antioxidants ([0058]) and may comprise cranberries ([0063]). Altom does not specifically discuss cranberry pomace as a polyphenol source or the source of the antioxidants. As evidenced by Perlman, cranberry pomace is a source of polyphenolic antioxidants ([0096]).
Where Altom as modified by Perth Cat Hospital, Yamka, and Capodieci renders obvious cranberry pomace as a fiber source, and where Perlman provides evidence that cranberry pomace is also a source of polyphenolic antioxidants, the claimed polyphenol source limitation has been met.
wherein the fiber component comprises a weight ratio of the high solubility fiber source to the low solubility fiber source of about 1:15 to about 1:2 – Altom teaches the nut shell (i.e., insoluble fiber) is present at up to 20 or 30 or 50% by weight of the pet food composition ([0038]), while the supplemental fiber, which includes the soluble fiber, is present from about 5-20% by weight of the pet food ([0043]). Altom further teaches that insoluble and soluble fibers are result-effective variables (as established from paragraphs [0007] and [0009] as discussed hereinabove). These amounts for ranges constitute amounts that render the claimed ratio obvious. For example, 5% by weight of soluble fiber : 50% by weight of insoluble fiber is a ratio of 1:10. Furthermore, Altom speaks to the effects imparted by both the insoluble and soluble fibers ([0032], [0041]). MPEP § 2144.05(II)(A) states, “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 of percentage ranges is the optimum combination of percentages.” As such, it would have been obvious for one of ordinary skill in the art to adjust the amount of the fiber sources and arrive at ratios of about 1:15 to about 1:2 as claimed through no more than routine experimentation.
Additionally, Xu teaches compositions suitable for maintaining or improving the gastrointestinal health of an animal, including improving stool quality, wherein the total dietary fiber of the compositions contains from about 10 to about 40% soluble fiber and from about 90 to about 60% insoluble fiber (Abstract). Xu teaches that any soluble fiber (col. 4, lines 17-25) and any insoluble fiber suitable for consumption by an animal can be used (col. 4, lines 26-33).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Altom with the teachings of Xu to include a ratio of the high solubility fiber source to the low solubility fiber source of about 10:90 to about 40:60 (i.e., about 1:9 to about 1:1.3). The claimed range overlaps the disclosed range. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I). One of ordinary skill in the art would have been motivated to do so because Altom speaks to the need to balance the amount of insoluble and soluble fibers in an animal food to reduce hairball occurrence while minimizing side effects, and Xu teaches that a ratio of soluble to insoluble fiber of about 1:9 to about 1:1.3 maintains or improves the gastrointestinal health of an animal. Xu shows, that:
1) it was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select the claimed range when making compositions to improve the gastrointestinal health of an animal, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use (see MPEP § 2144.07); and
2) there are advantages to doing such a thing, including maintaining or improving the gastrointestinal health of an animal, which is an objective of Altom ([0010]), which shows a recognition in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that beneficial result would have been produced by their combination (see MPEP § 2144(II) that states, “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination”).
One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because the claimed ratio of about 1:9 to about 1:1.3 substantially overlaps the claimed range of about 1:15 to 1:2.
wherein the inert, non-fermentable fiber source has polyphenols chemically or physically bound thereto, such that the controlled release matrix is adapted to deliver the polyphenol source to the lower gastrointestinal tract of the companion animal after ingestion by the companion animal – As described above, Altom teaches an animal food comprising pecan shells as insoluble (i.e., inert, non-fermentable) fiber ([0032]), and Kureck evidences that “pecan nut shells are characterized by higher amounts of polyphenols than the nuts” (p. 138, col. 1, ¶ 1). Altom as modified by Perth Cat Hospital, Yamka, Capodeici, and Xu teaches cranberry pomace as a source of insoluble fiber (as the fraction of total fiber that is not soluble fiber) (Capodieci, p. 6, SWP Formula 2, Total Fiber 75.30%, Soluble Fiber 4.5%) comprising polyphenol antioxidants (as evidenced by Perlman, [0096]). As evidenced by Quirós-Sauceda, phenolic compounds are ubiquitous in fruits and nuts (p. 1064, col. 2, ¶ 1), and phenolic compounds are chemically associated, or linked, to dietary fiber in the fruit matrix forming “antioxidant dietary fiber” (p. 1064, col. 2, ¶ 3; p. 1065, Fig. 1). Additionally, Altom discloses that the animal food comprising a nut shell aids in gastric and intestinal passage of ingested hair by trapping or binding ingested hair, increasing gastric emptying and allowing the ingested hair to pass out through the feces more frequently ([0031]). Finally, the instant specification provides, “The composition is produced by extrusion, dried, and then coated with a palatant. The process used to manufacture the composition described in Table 8 (below), ensures the creation of the inventive matrix of present invention.” ([0052]). Altom teaches that dry animal food compositions are made by mixing the ingredients, extruding the mixture into kibbles, and drying the kibbles ([0085]).
Where this combination of references discloses the same ingredients as in the claimed matrix, where Quirós-Sauceda provides evidence that polyphenols are chemically linked to dietary fiber, where Altom discloses delivery of the nut shell/insoluble fiber through the digestive tract, where the dry animal food of Altom is produced by extrusion and drying, and the instant specification provides that such a method ensures the creation of the inventive matrix, the limitation of a “controlled release matrix comprising an inert, non-fermentable fiber source having polyphenols chemically or physically bound thereto, such that the controlled release matrix is adapted to deliver the polyphenol source to the lower gastrointestinal tract of the companion animal after ingestion by the companion animal” has been met by the prior art. The limitation of a “controlled release pet food composition” is likewise met.
wherein the controlled release matrix, upon delivery to the lower gastrointestinal tract, produces elevated serum levels of microbial post-biotics through microbial metabolism of the fiber-bound polyphenols –
Altom as modified by Perth Cat Hospital, Yamka, Capodieci, and Xu discloses using the claimed method step of delivering a polyphenol source to the lower gastrointestinal tract of the companion animal by administering an effective amount of a controlled release pet food composition including all claimed limitations. When the method steps recited in the prior art reference are substantially identical to those of the claims, claimed properties of the resulting composition are presumed to be present in the composition of the prior art. The burden of proof shifts to the applicant to provide objective evidence (i.e., test data) to the contrary. See In re Best, 562, F.2d 1252, 1254, 195 USPQ 403, 433 (CCPA 1977). MPEP § 2112.01(I). In the present case, where the cited prior art teaches the same method step using the same composition, the claimed feature of the controlled release matrix, upon delivery to the lower gastrointestinal tract, producing elevated serum levels of microbial post-biotics through microbial metabolism of the fiber-bound polyphenols is expected to occur as a result of carrying out the method step.
For these reasons, claims 20 is rendered obvious.
Regarding claims 22-23, Altom, Perth Cat Hospital, Capodieci, Yamka, and Xu teach the methods of claims 1 and 20, respectively.
Altom does not explicitly discuss that ameliorating a symptom of an inflammatory bowel disease in the companion animal comprises improving stool quality of the companion animal.
However, Altom as modified by Perth Cat Hospital, Yamka, Capodieci, and Xu discloses using the claimed method step of delivering a polyphenol source to the lower gastrointestinal tract of the companion animal by administering an effective amount of a controlled release pet food composition including all claimed limitations. When the method steps recited in the prior art reference are substantially identical to those of the claims, claimed properties of the resulting composition are presumed to be present in the composition of the prior art. The burden of proof shifts to the applicant to provide objective evidence (i.e., test data) to the contrary. See In re Best, 562, F.2d 1252, 1254, 195 USPQ 403, 433 (CCPA 1977). MPEP § 2112.01(I). In the present case, where the cited prior art teaches the same method step using the same composition, the claimed feature of improving stool quality is expected to occur as a result of carrying out the method step.
Moreover, Altom speaks to the need to balance the amount of insoluble and soluble fibers in an animal food to reduce hairball occurrence while minimizing side effects ([0007], [0009]), and Xu teaches that a ratio of soluble to insoluble fiber of about 1:9 to about 1:1.3 maintains or improves the gastrointestinal health of an animal, and such compositions are administered to improve stool quality (Abstract). Modification of Altom with these teachings of Xu is obvious as discussed in the rejections of claims 1 and 20 hereinabove. Furthermore, Perth Cat Hospital renders obvious administering the animal food of Altom to a companion animal to ameliorate a symptom of inflammatory bowel disease as described above. Therefore, the teachings of Altom, Xu and Perth Cat Hospital provide the one of ordinary skill in the art with the expectation that stool quality would be improved as a result of administering the animal food composition, thus ameliorating a symptom of inflammatory bowel disease.
For these reasons, claims 22-23 are rendered obvious.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Altom et al. in view of Perth Cat Hospital, Capodeici, Yamka, et al., and Xu et al., as applied to claim 1 above, and as further evidenced by White et al. (White, B.L., Howard, L.R., and Prior, R.L. (2010) “Proximate and Polyphenolic Characterization of Cranberry Pomace”. J Agric Food Chem. 58(7), 4030-4036, cited on the IDS filed 27 October 2022).
Regarding claims 7-8, Altom, Perth Cat Hospital, Capodieci, Yamka, and Xu teach the method of claim 1.
The cited prior art, with evidence from White, also teaches that the polyphenol source comprises a flavonoid or a phenolic acid (re: claim 7) and that the polyphenol source provides a polyphenol selected from: quercetin, catechin, cyanidin, and a combination of two or more thereof (re: claim 8) – As the animal food composition of modified Altom as described regarding claim 1 teaches cranberry pomace as a polyphenolic antioxidant source, and White evidences that cranberry pomace comprises flavonols, a class of flavonoids, comprising quercetin (p. 4030, col. 2, ¶ 2), as well as catechin (p. 4033, col. 2, ¶ 2) and cyanidin (p. 4030, cols. 1-2, bridging sentence), claims 7-8 are also rendered obvious.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Altom et al. in view of Perth Cat Hospital, Capodeici, Yamka et al., and Xu et al., as applied to claim 1 above, and further in view of Josephson et al. (US 2008/0299286, cited on IDS filed on 27 October 2022).
Regarding claims 9-11, Altom, Perth Cat Hospital, Capodieci, Yamka, and Xu teach the method of claim 1.
Altom also teaches that the animal food comprises animal protein at 20-50% by weight of the animal food, and that the animal protein may include protein from chicken ([0054]).
The cited prior art does not teach that the pet food further comprises a source of hydrolyzed animal or plant protein comprising an amino acid profile (re: claim 9), that the source of hydrolyzed animal or plant protein comprises chicken liver (re: claim 10), and that the source of hydrolyzed animal or plant protein is present in an active content of from about 25 to about 45 wt.% (re: claim 11).
However, Josephson teaches a pet food composition comprising an animal protein, where the animal protein is a hydrolyzed chicken livers present at 25% by weight of the composition (p. 3, Formula 2). Josephson also teaches hydrolyzed liver as palatability enhancing ([0009]).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the hydrolyzed chicken liver of Josephson as the animal protein component in the animal food of modified Altom. First, Altom teaches the animal food comprising an animal protein derived from chicken at an amount from 20-50% by weight of the animal food ([0054]), but is silent as to a specific animal protein product. Since Josephson teaches that hydrolyzed chicken livers were known to be contained in pet foods in amounts falling within in the range disclosed by Altom, one of ordinary skill would have been motivated to incorporate hydrolyzed chicken liver protein in the animal food at 25% as claimed. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because the amount is consistent with amounts reported in the prior art, and hydrolyzed chicken liver is also taught to be palatability enhancing ([0009]).
Claims 9-11 are therefore rendered obvious.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Altom et al. in view of Perth Cat Hospital, Capodeici, Yamka et al., and Xu et al., as applied to claim 1 above, and further in view of Frank (Frank, J. (2015, October 2). Ancient Grains in Depth: Bulgur, Buckwheat, Millet, Spelt & Teff. UL Prospector. Retrieved December 15, 2025, from https://www.ulprospector.com/knowledge/3130/fbn-ancient-grains-in-depth-bulgur-buckwheat-millet-spelt-teff/) and Knutson (Knutson, J., (2015, July 30). Buckwheat: Old crop finds new life. Agweek. Retrieved December 16, 2025, from https://www.agweek.com/news/buckwheat-old-crop-finds-new-life).
Regarding claim 19, Altom, Perth Cat Hospital, Capodieci, Yamka, and Xu teach the method of claim 1.
Altom also teaches that the pet food may also comprise peas ([0059]), barley ([0065]), and tomato pomace ([0046]). “Peas” as disclosed by Altom are seen as whole peas, which comprise pea bran. Where Altom discloses these ingredients in the pet food composition, and these ingredients inherently comprise soluble fiber, Altom’s disclosure reads on “pea bran, barley, and tomato pomace” as claimed.
The cited prior art does not discuss that the high solubility fiber source comprises buckwheat groats.
However, Frank teaches that “buckwheat features more fiber than oatmeal” (p. 2, ¶ 3), and that in in 2014, a dry adult dog food containing buckwheat was introduced in Germany (p. 2, ¶ 4). Additionally, Knutson teaches that buckwheat groats also make a high-quality dog food (p. 3, ¶ 8).
MPEP § 2144.07 states, “The selection of a known material based on its suitability for its intended use support[s] a prima facie obviousness determination”. Since Frank and Knutson disclose that the claimed buckwheat groats is a suitable source of fiber for use in a dog food, it would have been prima facie obvious to select buckwheat groats as a fiber source in the animal food of Altom, which is also suitable for dogs ([0029]; claim 2).
Claim 19 is therefore rendered obvious.
Response to Arguments
Claim Rejections – 35 U.S.C. § 103: Applicant’s arguments filed on 27 April 2026 have been fully considered, but they are not persuasive.
Applicant first argued that the applied art does not disclose or teach the instantly claimed methods for ameliorating a symptom of an inflammatory bowel disease using the specifically claimed controlled release pet food composition or controlled release matrix to deliver a polyphenol source to the lower gastrointestinal tract (p. 7, ¶ 2 – p. 8, ¶ 3). First, because none of the applied references, individually or in combination, disclose or teach a controlled release matrix having: a fiber component comprising a combination of pecan shells, flax seed, citrus pulp, beet pulp, and cranberry pomace, and a polyphenol source comprising cranberry pomace, where the fiber component comprises a weight ratio of the high solubility fiber source to the low solubility fiber source of about 1:15 to abut 1:2 (p. 8, ¶ 3). Applicant argued that Altom speaks to the effects of adding nut shells (comprising insoluble fiber) and fermentable fiber (not high solubility fiber generally), and not any benefit associated with a certain weight ratio of high solubility fiber sources to low solubility fiber sources, much less the claimed ratio of about 1:15 to about 1:2 (p. 9, ¶ 2). Applicant argued that the applied art completely fails to identify the claimed weight ratio as a result effective variable, which is required to establish obviousness by routine experimentation (p. 9, ¶¶ 3-4).
Applicant’s arguments have been considered, but they are not persuasive. Altom teaches that feeding cats large amounts of supplemental indigestible/non-fermentable/insoluble fiber can reduce the formation and occurrence of hairballs, but can result in side effects such as constipation, excessive stool output, decreased nutrient digestibility, and inferior coat appearance ([0007]), and that feeding high amounts of fermentable/gelling/soluble fibers to induce satiety, improve glucose homeostasis, and delay gastric emptying can cause side effects including loose and/or watery stools, nausea, and vomiting ([0009]). Therefore, Altom teaches that insoluble and soluble fiber are result-effective variables in an animal food composition—insoluble and soluble fibers are desired for beneficial effects, but too much of either causes unwanted side effects, so an optimal amount must be determined.
Regarding the instantly claimed controlled release composition having the particularly recited components and ingredients, and a weight ratio of the soluble fiber source to the insoluble fiber source of about 1:15 to about 1:2, these elements are made obvious as described in the rejections of claims 1 and 20 above. Altom as modified by Yamka and Capodeici discloses the requisite ingredients as claimed. Altom teaches the nut shell (i.e., insoluble fiber) is present at up to 20 or 30 or 50% by weight of the pet food composition ([0038]), while the supplemental fiber, which includes the soluble fiber, is present from about 5-20% by weight of the pet food ([0043]). Altom further teaches that insoluble and soluble fibers are result-effective variables (as established from paragraphs [0007] and [0009] as discussed hereinabove). Where insoluble fiber sources and soluble fiber sources are disclosed by Altom, a ratio of the two necessarily exists. These amounts for ranges constitute amounts that render the claimed ratio obvious. For example, 5% by weight of soluble fiber : 50% by weight of insoluble fiber is a ratio of 1:10. MPEP § 2144.05(II)(A) states, “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 of percentage ranges is the optimum combination of percentages.” As such, it would have been obvious for one of ordinary skill in the art to adjust the amount of the fiber sources and arrive at ratios of about 1:15 to about 1:2 as claimed through no more than routine experimentation.
Additionally, Xu teaches compositions suitable for maintaining or improving the gastrointestinal health of an animal, including improving stool quality, wherein the total dietary fiber of the compositions contains from about 10 to about 40% soluble fiber and from about 90 to about 60% insoluble fiber (Abstract). Xu teaches that any soluble fiber (col. 4, lines 17-25) and any insoluble fiber suitable for consumption by an animal can be used (col. 4, lines 26-33).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Altom with the teachings of Xu to include a ratio of the high solubility fiber source to the low solubility fiber source of about 10:90 to about 40:60 (i.e., about 1:9 to about 1:1.3). The claimed range overlaps the disclosed range. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I). One of ordinary skill in the art would have been motivated to do so because Altom speaks to the need to balance the amount of insoluble and soluble fibers in an animal food to reduce hairball occurrence while minimizing side effects, and Xu teaches that a ratio of soluble to insoluble fiber of about 1:9 to about 1:1.3 maintains or improves the gastrointestinal health of an animal. Xu shows, that:
1) it was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select the claimed range when making compositions to improve the gastrointestinal health of an animal, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use (see MPEP § 2144.07); and
2) there are advantages to doing such a thing, including maintaining or improving the gastrointestinal health of an animal, which is an objective of Altom ([0010]), which shows a recognition in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that beneficial result would have been produced by their combination (see MPEP § 2144(II) that states, “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination”).
One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because the claimed ratio of about 1:9 to about 1:1.3 substantially overlaps the claimed range of about 1:15 to 1:2.
Applicant next argued that the applied art fails to disclose or teach controlled release matrices having a fiber component comprising the specifically recited combination and amounts of pecan shells, flax seed, citrus pulp, beet pulp, and cranberry pomace and a polyphenol source comprising cranberry pomace (p. 10, ¶ 1). Applicant argued that the applied art fails to teach or provide guidance for forming a controlled release matrix comprising (1) pecan shells, (2) flax seed, (3) citrus pulp, (4) beet pulp, and (5) cranberry pomace, and without such guidance, one of ordinary skill in the art would not have been motivated to make the necessary modifications to arrive at the instantly claimed invention without improper hindsight (p. 10, ¶ 2). Additionally, Applicant challenged the Office’s previous response to Applicant’s assertion of improper hindsight reasoning citing In re McLaughlin, and asserted that the art does not suggest combining the elements as claimed (p. 10, ¶ 3 – p. 11, ¶ 2).
Applicant’s argument has been considered, but it is not persuasive. Applicant’s argument regarding In re McLaughlin is acknowledged. However, the rejections do not rely upon the case law of In re McLaughlin.
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.
Office personnel must consider the contents of the claims in order to properly apply the factual inquiries. It has been found that the elements of the claims were known, and their combination would have been obvious. Applicant is referred to the rejections hereinabove regarding how each of the factual inquiries are applied to the instant claims.
Regarding the claimed “controlled release matrix” it is noted that the processing methods of Altom (i.e., extrusion and drying ([0085])) are the same as disclosed in the examples of the instant specification, for example in paragraph [0052], which are described as ensuring the creation of the inventive matrix. Applying the term “controlled release matrix” to the extruded product of the claims does not differentiate it from the extruded product of the prior art; a rose by any other name is still a rose.
Applicant next argued that the applied art alone, or in combination, fails to teach or suggest the specific therapeutic mechanism recited by the claimed inventive method, wherein upon delivery to the lower gastrointestinal tract, the controlled release matrix produces elevated serum levels of microbial post-biotics through microbial metabolism of the fiber-bound polyphenols for treating IBD (p. 11, ¶ 3 – p. 12, ¶ 2).
Applicant’s argument has been considered, but it is not persuasive. The cited prior art discloses using the claimed method step of delivering a polyphenol source to the lower gastrointestinal tract of the companion animal by administering an effective amount of a controlled release pet food composition including all claimed limitations as described in the rejections of claims 1 and 20. When the method steps recited in the prior art reference are substantially identical to those of the claims, claimed properties of the resulting composition are presumed to be present in the composition of the prior art. The burden of proof shifts to the applicant to provide objective evidence (i.e., test data) to the contrary. See In re Best, 562, F.2d 1252, 1254, 195 USPQ 403, 433 (CCPA 1977). MPEP § 2112.01(I). In the present case, where the cited prior art teaches the same method step using the same composition, the claimed feature of the controlled release matrix, upon delivery to the lower gastrointestinal tract, producing elevated serum levels of microbial post-biotics through microbial metabolism of the fiber-bound polyphenols is expected to occur as a result of carrying out the method step.
Applicant further argued that the rejections should be withdrawn because evidence of unexpected results exists (p. 12, ¶ 4). Applicant asserted that Examples 4 and 5 establish that the claimed controlled release pet food compositions provide significant technical benefits as compared to comparative compositions having a similar amount of fiber, but with the fiber coming from other sources, such as whole yellow corn, such significant improvement not being suggested by the applied art, and, thus, being unexpected by one of ordinary skill in the art (p. 12, last ¶).
Applicant’s assertion of unexpected technical results is acknowledged. Applicant’s argument has been considered, but it is not found to be persuasive. MPEP § 2145 states, “If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc)”, and “[r]ebuttal evidence may include evidence of ‘secondary considerations,’ such as ‘commercial success, long felt but unsolved needs, [and] failure of others.’ Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 4459, 467. See also, e.g., In re Piasecki, 745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir. 1984) (commercial success). Rebuttal evidence may also include evidence that the claimed invention yields unexpectedly improved properties or properties not present in the prior art. Rebuttal evidence may consist of a showing that the claimed compound possesses unexpected properties. Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1901. A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997)”. However, as provided by MPEP § 2145(II), “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)”, and “‘[t]he fact that appellant 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.’ Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”. Furthermore, “[e]vidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).” See MPEP § 716.02(c)(I). “‘Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.; In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967)”. See MPEP § 716.02(c)(II).
“Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’ In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”. See MPEP § 716.02(d).
In the present case, Applicant’s Examples 4 and 5 evaluate stool quality of healthy canines and canines suffering from IBD after consuming a comparative control diet or the test diet of the invention. Improvement of stool quality is observed in animals that received the test diets as compared to those that received the control diets. However, Applicant’s evidence is not commensurate in scope with the claimed invention. The examples are not commensurate in scope with the claimed invention at least because experimental data is limited to effects observed in the specific treatment populations of healthy dogs and dogs with IBD. It cannot be ascertained whether the effects are observed in other animal populations covered by the scope of the claims (i.e., any companion animal).
Applicant further argued that the rejections levied against dependent claims 3, 7-8, 9-11, and 19 should be withdrawn because the additional cited prior art does not cure the deficiencies of the applied art as levied against claim 1 (p. 13, ¶ 2 – p. 14, ¶ 1).
In response, Applicant’s arguments against claim 1 are not persuasive. As such, the rejection of these claims is maintained.
For at least these reasons, Applicant’s arguments are not found to be persuasive. Claims 1-3, 7-12, and 16-23 are rejected under 35 U.S.C. § 103 as presented hereinabove.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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