DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Request for Continued Examination (RCE under 37 CFR 1.114), the Response, and Amendment filed 01/22/2026 is acknowledged.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 76-78
Withdrawn claims: None
Previously cancelled claims: 1-75, 79-80
Newly cancelled claims: None
Amended claims: 76
New claims: None
Claims currently under consideration: 76-78
Currently rejected claims: 76-78
Allowed claims: None
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/22/2026 has been entered.
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 76-78 are rejected under 35 U.S.C. 103 as being unpatentable over Giffard (US 2008/0260893; previously cited) in view of Berry (US 2016/0271188).
Regarding claim 76, Giffard teaches a method comprising administering a pet food product comprising a probiotic and sugar beet pulp as a prebiotic to the companion animal [0007], [0013], [0034] daily for 10 days in order to significantly increase fecal score of the animal [0087]-[0089]. This disclosed time period of 10 days does not fall within the claimed time period of at least 14 days. However, Giffard discloses that its method not only improves digestion, but that its method also maintains intestinal/digestive health [0055], [0060]-[0061]. Therefore, in order to maintain the improved digestion seen in animals administered the pet food product, a skilled practitioner would have understood that administration of the product may go beyond an initial 10 day treatment period, thereby providing a time range which overlaps the claimed time range.
Giffard teaches that the probiotic may be Bacteroides sp. and/or Holdemanella sp. (corresponding to Eubacterium) [0029] and that the pet food comprises the probiotic is in an amount of 1x108-1x1011 CFU per day [0032], which falls within the claimed range. Giffard also teaches that the probiotic in the pet food product improves intestinal microbial balance; the probiotic in the pet food product selectively promotes the growth and/or activity of the health-promoting bacteria in the gut [0008]; and that the pet food product reduces the incidence and duration/severity of diarrhea and reduces the vulnerability of the companion animal to further episodes of diarrhea [0006], [0058], [0087]-[0089]. These disclosures show that the method of Giffard comprising providing the pet food product to a companion animal is a method for treating intestinal dysbiosis in a companion animal in need thereof as presently claimed. These disclosures also show that the companion animal has diarrhea prior to providing the pet food product and that the companion animal has reduced diarrhea incidence after receiving the pet food product as presently claimed.
Giffard teaches that the sugar beet pulp is a dietary fiber component [0034]; that the pet food product comprises the dietary fiber component at a concentration of 0.15-8 wt.% on a dry matter basis [0038]; and that the pet food product has a moisture content of 5-90 wt.% [0016]. From these disclosures, Giffard discloses concentrations of sugar beet pulp in the pet food product which encompass the claimed concentration range (i.e., a pet food product comprising the maximum 95 wt.% dry matter and the maximum 8 wt.% sugar beet pulp as the dietary fiber based on dry weight contains 7.6 wt.% dietary fiber sugar beet pulp while a pet food product comprising the minimum 10 wt.% dry matter and the minimum 0.15 wt.% sugar beet pulp as the dietary fiber based on dry weight contains 0.015 wt.% sugar beet pulp). Giffard discloses that the pet food product is provided in an amount of 500 mg/kg bodyweight per day (corresponding to 0.5 g/kg bodyweight per day) [0087], which falls within the claimed dosage per kg bodyweight. Giffard also discloses that the bodyweight of the companion animals ranges from less than 5 kg to greater than 50 kg [0109], thereby providing a range of total daily amounts of pet food product which at least overlaps the claimed daily amount of “up to about 300 g/day” (e.g., providing a pet food product in an amount of 500 mg/kg bodyweight per day to an animal weighing 5 kg means that the animal receives 2.5 g pet food product per day).
Regarding ranges disclosed by Giffard which overlap or encompass the claimed ranges, it would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.I.
Giffard teaches that the probiotic in its composition may be Bacteroides sp. and/or Holdemanella sp. [0029]. Giffard does not disclose that the probiotic is selected from the group consisting of Faecalibacterium prausnitzii, Bacteroides plebeius, and Holdemanella biformis. Giffard also does not teach that the companion animal has an increased abundance of one or more bacterium comprising the 16S rRNA described in present claim 76.
However, Berry teaches a method of treating intestinal dysbiosis in a companion animal (corresponding to household pets) wherein the method comprises administering a composition containing bacteria for the reconstitution, modulation, or creation of a beneficial bacterial flora in the gastrointestinal tract of the companion animal [0639], [0819]. Berry teaches that the bacteria may be Faecalibacterium pausnitzii, Bacteroides plebeius, and/or Holdemanella biformis (corresponding to Eubacterium biforme) ([0663]-[0664], Table 1 on pages 121-122 and 132).
It would have been obvious for a person of ordinary skill in the art to have modified the Bacteroides species and/or Holdemanella species of Giffard to be Bacteroides plebeius Holdemanella biformis as taught by Berry. Since Giffard teaches that the probiotic in its pet food product improves intestinal microbial balance; the probiotic in the pet food product selectively promotes the growth and/or activity of the health-promoting bacteria in the gut [0008]; and that the probiotic in its composition may be Bacteroides sp. and/or Holdemanella sp. [0029], but does not disclose a suitable species of Bacteroides or Holdemanella, a skilled practitioner would have been motivated to consult an additional reference such as Berry in order to determine a suitable Bacteroides species and a suitable Holdemanella species for improving microbial balance and selectively promoting the growth and/or activity of the health-promoting bacteria in the gut, thereby rendering the claimed Bacteroides plebeius and Holdemanella biformis obvious. Furthermore a skilled practitioner would readily recognize that the probiotic bacteria of Giffard may also comprise Faecalibacterium pausnitzii as taught by Berry since Berry discloses that Faecalibacterium pausnitzii is also a probiotic bacteria to treat dysbiosis. Therefore, the claimed Faecalibacterium pausnitzii is also rendered obvious.
In regard to the companion animal having an increased abundance of a specific bacterium having a 16S rRNA as described in the present claim, since the combination of Giffard and Berry teaches embodiments which are the same method as claimed and instantly disclosed, the method disclosed by the combination of Giffard and Berry would necessarily have the claimed ability to increase abundance of the specific bacterium described in present claim 76. It is noted that claim 76 is a recitation of an inherent characteristic wherein the method of the combination of Giffard and Berry is capable of comprising the claimed ability to increase abundance of the specific bacterium described in present claim 76 as a function of the ingredients in the pet food product and the administration of that product to a companion animal as claimed and as disclosed. Regarding product claims, when the ingredient recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be present in the ingredient of the reference. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s function, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F .3d 1342, 1347, 51 USPQ2d 1943. 1947 (Fed. Cir. 1999). Furthermore, the Office does not have laboratory facilities to test claim limitations drawn toward results of practicing the method as claimed. Accordingly, such an ability to increase abundance of the specific bacterium described in present claim 76 does not serve to distinguish the product as claimed from the prior art and is thus considered obvious to one having ordinary skill in the art.
Regarding claim 77, Giffard teaches the invention as described above in claim 76, including the pet food product is a dietary supplement (corresponding to the pet food product being in the form of a pet food snack) [0017] or a functional food (corresponding to the product providing benefits to the animal) [0055]-[0061].
Regarding claim 78, Giffard teaches the invention as described above in claim 76. Giffard does not specifically disclose that the pet food product is a topper. However, the term “topper” does not imply any structural, functional, or manipulative difference between the claimed invention and that of the prior art; therefore, the term “topper” does not limit the claim and does not distinguish the claimed invention over the prior art process so that the pet food of Giffard may be effectively categorized as a “topper”.
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 76-78 over Giffard: Applicant’s arguments have been fully considered and are considered unpersuasive or moot.
Applicant argued that a skilled practitioner would not have understood that the sugar beet pulp of Giffard contains a mixture of soluble and insoluble fiber, protein, fat, and residual sugars as Giffard discloses that its composition comprises dietary fiber components from sugar beet pulp. For this reason, Applicant argued that Giffard fails to disclose a pet food product explicitly containing sugar beet pulp in any form that is administered to a dog to improve gut health and consequently fails to provide an enabling disclosure regarding a method comprising administering a pet food product comprising sugar beet pulp as presently claimed (Applicant’s Remarks, page 3, 1st paragraph under section II – page 4, 3rd paragraph).
However, in response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., sugar beet pulp containing a mixture of soluble and insoluble fiber, protein, fat, and residual sugars) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, Giffard states “The prebiotic component of the foodstuff is not limiting. It includes oligosaccharides […] as well as one or more dietary fiber components such as […] beet pulp (such as sugarbeet pulp)” in [0034]. Giffard does not state that the pet food product contains dietary fibers derived from sugar beet pulp; Giffard states that the pet food product contains sugar beet pulp as the dietary fiber component. Therefore, a skilled practitioner would readily recognize that the pet food composition may comprise whole sugar beet pulp as the dietary fiber component, thereby rendering the claimed sugar beet pulp obvious, especially wherein the present claims do not require any specific compositional make-up of the claimed sugar beet pulp; wherein the use of sugar beet pulp in digestive health and the compositional make-up of sugar beet pulp are well-known in the art; and wherein the Applicant has not demonstrated any specific effects due to a specific compositional make-up of the sugar beet pulp. As such, Applicant’s arguments regarding Giffard not disclosing the claimed sugar beet pulp are unpersuasive.
Applicant amended claim 76 to recite that the probiotic in the pet food composition is at least one of Faecalibacterium prausnitzii, Bacteroides plebeius, and Holdemanella biformis. Applicant argued that Giffard does not disclose these bacterial probiotic species; and that a skilled practitioner would not include these bacterial species as a probiotic within hindsight (Applicant’s Remarks, page 4, 4th paragraph – page 5, 2nd paragraph).
However, in the new grounds of rejection necessitated by the amendment of claim 76, the features of claim 76 are rendered obvious by the combination of Giffard and Berry. Therefore, Applicant’s arguments based on Giffard alone are moot.
As described above in the rejection of amended claim 76, it would have been obvious for a person of ordinary skill in the art to have modified the Bacteroides species and/or Holdemanella species of Giffard to be Bacteroides plebeius Holdemanella biformis as taught by Berry. Giffard teaches that the probiotic in its pet food product improves intestinal microbial balance; the probiotic in the pet food product selectively promotes the growth and/or activity of the health-promoting bacteria in the gut [0008]; and that the probiotic in its composition may be Bacteroides sp. and/or Holdemanella sp. [0029], but does not disclose a suitable species of Bacteroides or Holdemanella. Therefore, a skilled practitioner would have been motivated to consult an additional reference such as Berry in order to determine a suitable Bacteroides species and a suitable Holdemanella species for improving microbial balance and selectively promoting the growth and/or activity of the health-promoting bacteria in the gut. Berry teaches a method of treating intestinal dysbiosis in a companion animal wherein the method comprises administering a composition containing bacteria for the reconstitution, modulation, or creation of a beneficial bacterial flora in the gastrointestinal tract of the companion animal [0639], [0819]. Berry teaches that the bacteria may be Faecalibacterium pausnitzii, Bacteroides plebeius, and/or Holdemanella biformis ([0663]-[0664], Table 1 on pages 121-122 and 132), thereby rendering the claimed bacterial species obvious.
Since the prior art has been shown to render the present claims obvious and Applicant’s arguments have been shown to be unpersuasive or moot, the rejections of the claims stand as written herein.
Conclusion
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/KELLY P KERSHAW/Examiner, Art Unit 1791