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 .
Claim Objections
Claim 15 is objected to because of the following informalities: there appears to be a typographical error as “fermentate” is misspelled in line 3. Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 8-9, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. (WO 2015/004055 A1; Jan. 15, 2015) as evidenced by Zhen et al. (Structure and anti-inflammatory capacity of peptidoglycan from Lactobacillus acidophilus in EAW-264.7 cells; Carbohydrate Polymers 96, 2013, pp. 466-473; Retrieved from Internet URL: https://doi.org/10.1016/j.carbpol.2013.04.028).
Regarding claim 1, Berger discloses a pet food composition comprising:
a fermentate including non-viable, non-pathogenic gram-positive bacteria (e.g. Lactobacillus strains) (page 2 lines 1-10; page 4 line 13-14), wherein the fermentate is present in an effective amount to induce a probiotic effect (page 2 line 11; page 5 lines 5-25).
Berger clearly shows that the amount of fermentate present in the food composition can vary and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of fermentate in the pet food composition that produces a desired probiotic effect. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
With respect to the fermentate including peptidoglycan in an amount of at least 80% by dry weight of the fermentate, the examiner notes that the Lactobacillus strains inherently comprise peptidoglycan as evidenced by Zhen, which teaches that gram-positive Lactobacillus bacteria contain peptidoglycan in an amount of 40-90% of its dry weight (page 467, para 2), which overlaps the claimed amount of at least 80% dry weight. In the 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) Further, it would have been obvious to one of ordinary skill in the art to process the bacteria so as to retain a desired amount of peptidoglycan as it contributes to an anti-inflammatory effect (page 467, para 2), and
a prebiotic including an oligosaccharide component, wherein the oligosaccharide component can be alginate, mannan-oligosaccharides (MOS), or fructo-oligosaccharides (FOS) (page 39, lines 15-30).
While Berger teaches a prebiotic combined with the fermentate, Berger fails to specifically teach that the oligosaccharide component is present in an amount of about 0.5% to 2% by weight of the pet food composition. However, Berger teaches that the components are present in effective amounts (page 35 line 30) and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of prebiotic in the pet food composition depending on the desired prebiotic effect. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
Regarding claim 2, Berger teaches that the non-pathogenic gram-positive bacteria includes a probiotic bacteria (page 2 lines 1-10).
Regarding claim 3, Berger teaches that the probiotic bacteria that can also include Lactobacillus acidophilus (page 4, lines 13-14: wherein the bacteria are provided as a fermentate; page 11 line 25 – page 12 line 5).
Regarding claim 4, with respect to the amount of fermentate in the pet food composition, as stated above with respect to claim 1, Berger teaches that the fermentate is present in an effective amount to induce a probiotic effect (page 2 line 11; page 5 lines 5-25). Berger clearly shows that the amount of fermentate present in the food composition can vary and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of fermentate in the pet food composition that produces a desired probiotic effect. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
Regarding claim 5, as stated above with respect to claim 1, the examiner notes that the Lactobacillus strains inherently comprise peptidoglycan as evidenced by Zhen, which teaches that gram-positive Lactobacillus bacteria contain peptidoglycan in an amount of 40-90% of its dry weight (page 467, para 2), which overlaps the claimed amount of 85-95% dry weight. In the 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) Further, it would have been obvious to one of ordinary skill in the art to process the bacteria so as to retain a desired amount of peptidoglycan as it contributes to an anti-inflammatory effect (page 467, para 2).
Regarding claims 8-9, as stated above, Berger teaches that the oligosaccharide component can be mannan-oligosaccharides (MOS) or fructo-oligosaccharides (FOS) (page 39, lines 15-30).
With respect to the amount of MOS or FOS in the pet food composition, Berger teaches that the components are present in effective amounts (page 35 line 30) and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of prebiotic in the pet food composition depending on the desired prebiotic effect. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
Regarding claim 11, Berger further teaches that the prebiotic can be inulin (page 39 lines 15-25).
With respect to the amount of inulin in the pet food composition, Berger teaches that the components are present in effective amounts (page 35 line 30) and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of inulin in the pet food composition depending on the desired prebiotic effect and nutritional profile, wherein inulin contributes fiber. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
Regarding claim 12, Berger further teaches that the prebiotic can contribute soluble fiber to the pet food composition (page 39 lines 20-30).
With respect to the amount of soluble fiber in the pet food composition, Berger teaches that the components are present in effective amounts (page 35 line 30) and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of fiber in the pet food composition depending on the desired prebiotic effect and nutritional profile. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
Regarding claim 13, Berger teaches that the pet food composition can be a dry kibble having a moisture content of 7-10%, thus falling within the claimed range of less than 12% by weight (page 29, lines 20-30; page 52 lines 5-10).
Regarding claim 14, Berger teaches that the pet food composition if formulated for a dog or a coat (page 29 lines 25-30).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. (WO 2015/004055 A1; Jan. 15, 2015) as evidenced by Zhen et al. (Structure and anti-inflammatory capacity of peptidoglycan from Lactobacillus acidophilus in EAW-264.7 cells; Carbohydrate Polymers 96, 2013, pp. 466-473; Retrieved from Internet URL: https://doi.org/10.1016/j.carbpol.2013.04.028) as applied to claim 1 above, and further in view of Farmer et al. (US 2021/0307361 A1; Oct. 7, 2021).
Regarding claim 6, as stated above with respect to claim 1, Berger teaches that the pet food composition comprises oligosaccharides that can be alginate, but fails to specifically teach alginate oligosaccharide (AOS), wherein at least a portion of the AOS is contributed by kelp.
Farmer disclose a pet food composition comprising a prebiotic that can be kelp ([0018]).
As kelp is a known prebiotic source, it would have been obvious to one of ordinary skill in the art to include kelp as the prebiotic in Berger depending on the nutritional source. This is merely substitution of one known prebiotic for another to yield the predictable result of providing a prebiotic effect to the pet food composition.
Therefore, the combination of Berger with Farmer, wherein the pet food composition comprises kelp, would necessarily result in the composition comprising AOS due to the presence of kelp, wherein at least a portion of the AOS is contributed by kelp. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Regarding claim 7, with respect to the amount of kelp present, as stated above, Berger teaches that the prebiotics can be present in effective amounts to produce a desired effect (page 35 line 30) and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of kelp in the pet food composition depending on the desired prebiotic effect and nutritional profile. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. (WO 2015/004055 A1; Jan. 15, 2015) as evidenced by Zhen et al. (Structure and anti-inflammatory capacity of peptidoglycan from Lactobacillus acidophilus in EAW-264.7 cells; Carbohydrate Polymers 96, 2013, pp. 466-473; Retrieved from Internet URL: https://doi.org/10.1016/j.carbpol.2013.04.028) as applied to claim 1 above, and further in view of Saxe et al. (US 2011/0052752 A1; Mar. 3, 2011).
Regarding claim 10, as stated above with respect to claim 1, Berger teaches that the pet food composition comprises a prebiotic, but fails to specifically teach that the prebiotic includes beet pulp.
Saxe disclose a pet food composition comprising a beet pulp as a source of fiber ([0156]).
As beet pulp is a known prebiotic fiber source, it would have been obvious to one of ordinary skill in the art to include beet pulp as the prebiotic in Berger depending on the nutritional source. This is merely substitution of one known prebiotic for another to yield the predictable result of providing a prebiotic effect to the pet food composition.
With respect to the amount of kelp present, as stated above, Berger teaches that the prebiotics can be present in effective amounts to produce a desired effect (page 35 line 30) and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of beet pulp in the pet food composition depending on the desired prebiotic effect and nutritional profile. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
Claims 15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. (WO 2015/004055 A1; Jan. 15, 2015) in view of Farmer et al. (US 2021/0307361 A1; Oct. 7, 2021) as evidenced by Zhen et al. (Structure and anti-inflammatory capacity of peptidoglycan from Lactobacillus acidophilus in EAW-264.7 cells; Carbohydrate Polymers 96, 2013, pp. 466-473; Retrieved from Internet URL: https://doi.org/10.1016/j.carbpol.2013.04.028).
Regarding claim 15, Berger discloses a pet food composition comprising:
a fermentate including non-viable, non-pathogenic gram-positive bacteria (e.g. Lactobacillus strains) (page 2 lines 1-10; page 4 line 13-14). Berger teaches that the probiotic bacteria that can include Lactobacillus acidophilus (page 4, lines 13-14: wherein the bacteria are provided as a fermentate; page 11 line 25 – page 12 line 5), wherein the fermentate is present in an effective amount to induce a probiotic effect (page 2 line 11; page 5 lines 5-25).
Berger clearly shows that the amount of fermentate present in the food composition can vary and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of fermentate in the pet food composition that produces a desired probiotic effect. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
With respect to the fermentate including peptidoglycan in an amount of 85-95% by dry weight of the fermentate, the examiner notes that the Lactobacillus strains inherently comprise peptidoglycan as evidenced by Zhen, which teaches that gram-positive Lactobacillus bacteria contain peptidoglycan in an amount of 40-90% of its dry weight (page 467, para 2), which overlaps the claimed amount. In the 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) Further, it would have been obvious to one of ordinary skill in the art to process the bacteria so as to retain a desired amount of peptidoglycan as it contributes to an anti-inflammatory effect (page 467, para 2), and
a prebiotic (page 39 line 14), but fails to specifically disclose kelp as the prebiotic. Farmer disclose a pet food composition comprising a prebiotic that can be kelp ([0018]). As kelp is a known prebiotic source, it would have been obvious to one of ordinary skill in the art to include kelp as the prebiotic in Berger depending on the nutritional source. This is merely substitution of one known prebiotic for another to yield the predictable result of providing a prebiotic effect to the pet food composition.
While Berger teaches a prebiotic combined with the fermentate, and Farmer teaches that the prebiotic can be kelp, both fail to specifically teach that the prebiotic including kelp is present in an amount of about 0.2% to 1% by weight of the pet food composition. However, Berger teaches that the components are present in effective amounts (page 35 line 30) and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of prebiotic/kelp in the pet food composition depending on the desired prebiotic effect and nutritional profile. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
Regarding claim 17, as stated above, Berger teaches a prebiotic, wherein the prebiotic includes an oligosaccharide component, wherein the oligosaccharide component can be alginate, mannan-oligosaccharides (MOS), or fructo-oligosaccharides (FOS) (page 39, lines 15-30).
While Berger teaches a prebiotic combined with the fermentate, Berger fails to specifically teach that the oligosaccharide component is present in an amount of about 0.5% to 2% by weight of the pet food composition. However, Berger teaches that the components are present in effective amounts (page 35 line 30) and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of prebiotic in the pet food composition depending on the desired prebiotic effect. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
Regarding claim 18, Berger teaches that the prebiotic can be mannan-oligosaccharides (MOS), fructo-oligosaccharides (FOS), or inulin (page 39, lines 15-30).
It would have been obvious to have the prebiotic include all three depending on the desired effect. 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.)”
Therefore, combining the three prebiotics would merely form a prebiotic composition that is used for the same purpose.
With respect to the amount of each component, Berger teaches that the components are present in effective amounts (page 35 line 30) and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of each in the pet food composition depending on the desired prebiotic effect. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
Regarding claim 19, Berger further teaches that the prebiotic can contribute soluble fiber to the pet food composition (page 39 lines 20-30).
With respect to the amount of soluble fiber in the pet food composition, Berger teaches that the components are present in effective amounts (page 35 line 30) and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of fiber in the pet food composition depending on the desired prebiotic effect and nutritional profile. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. (WO 2015/004055 A1; Jan. 15, 2015) and Farmer et al. (US 2021/0307361 A1; Oct. 7, 2021) as evidenced by Zhen et al. (Structure and anti-inflammatory capacity of peptidoglycan from Lactobacillus acidophilus in EAW-264.7 cells; Carbohydrate Polymers 96, 2013, pp. 466-473; Retrieved from Internet URL: https://doi.org/10.1016/j.carbpol.2013.04.028) as applied to claim 15 above, and further in view of Saxe et al. (US 2011/0052752 A1; Mar. 3, 2011).
Regarding claim 16, as stated above with respect to claim 15, Berger teaches that the pet food composition comprises a prebiotic, but fails to specifically teach that the prebiotic includes beet pulp.
Saxe disclose a pet food composition comprising a beet pulp as a source of fiber ([0156]).
As beet pulp is a known prebiotic fiber source, it would have been obvious to one of ordinary skill in the art to include beet pulp as the prebiotic in Berger depending on the nutritional source. This is merely substitution of one known prebiotic for another to yield the predictable result of providing a prebiotic effect to the pet food composition.
With respect to the amount of kelp present, as stated above, Berger teaches that the prebiotics can be present in effective amounts to produce a desired effect (page 35 line 30) and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of beet pulp in the pet food composition depending on the desired prebiotic effect and nutritional profile. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "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).
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