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 1 is objected to because of the following informalities:
Regarding claim 1, claim 1 recites “wherein a mass ratio of cell wall fragments from lysed or partially lysed cells of Saccharomyces cerevisiae to Montmorillonite clay…” in line 17. It appears that the claim should be changed to “wherein a mass ratio of the cell wall fragments from lysed or partially lysed cells of Saccharomyces cerevisiae to the montmorillonite clay”.
Regarding claim 1, claim 1 in line 19 recites “prebiotic material” and appears should be changed to “the prebiotic material”.
Regarding claim 1, claim 1 recites “Montmorillonite clay” throughout the claims, which does not need to be capitalized and appears should be changed to “montmorillonite clay”.
Regarding claim 1, “Mannans”, “Beta-glucans” and “Vitamin-C” should be changed to “mannans”, “beta-glucans” and “vitamin C”.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, claim 3 recites “said Saccharomyces cerevisiae”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Broomhead US 2014/0099373 in view of Staeger WO 2007/143093A2 in view of Dikovskiy US 2012/0196811 in view of Zhu CN103243028A (Espacenet Translation) in view of Dierking US 2006/0067985 in view of Flickinger et al. in view of Stillmann US 2007/0009576.
Regarding claim 1, Broomhead discloses a pet food additive (animal food additive), said pet food additive comprising cell wall fragments from lysed cells of Saccharomyces cerevisiae ([0060], claim 1, 17). It is noted the Broomhead discloses that the yeast component can be a yeast fragment and a component of the yeast cell (such as yeast cell wall) ([0060]), therefore Broomhead suggests the use of cell wall fragments obviously obtained from lysed cells, and Broomhead discloses that the yeast can be Saccharomyces cerevisiae (claim 1, 17). Broomhead discloses that the yeast component includes mannans, beta-glucans ([0220])
Broomhead discloses that the pet food additive includes montmorillonite clay (claim 1, 11).
Broomhead discloses that the pet food additive can include a prebiotic material ([0075], [0220]).
Broomhead discloses that the additive can comprise oligosaccharides ([0075]).
Broomhead discloses that the additive can comprise fiber ([0057], [0075]).
Broomhead discloses that the additive can include xanthan gum ([0089])
Broomhead discloses that the additive can comprise vegetable starch ([0089])
Broomhead discloses that the additive can comprise glucose ([0089])
Broomhead discloses that the additive can comprise di-calcium phosphate ([0089]).
Staeger discloses that yeast cell wall fragments commonly contain B vitamins (Pg. 10 lines 2-12), therefore it is obvious that the cell wall fragments of Broomhead contain B vitamins.
Claim 1 differs from Broomhead in the recitation that the prebiotic material specifically is selected from inulin.
Dikovskiy discloses that known prebiotic material for inclusion in animal food preparations includes inulin (abstract). It would have been obvious to modify the pet food additive of Broomhead to include inulin as taught by Dikovskiy in order to enhance the nutrition provided by the pet food additive. It has been held that “Combining prior art elements according to known methods to yield predictable results” supports a conclusion of obviousness (MPEP 2143.I.A).
Claim 1 differs from Broomhead in the recitation that the mass ratio of fragments from lysed cells of Saccharomyces cerevisiae to montimorillonite clay is in the range of 6:1 to 4:1.
Zhu discloses a composition comprising yeast cell walls (comprising mannans, beta-glucan, B Vitamins) (Abstract) and montmorillonite clay where the ratio of yeast cell wall to montmorillonite is 1:9-9:1, encompassing the claimed range (Espacenet Translation, [0036], [0036]). Zhu discloses that a purpose of the composition includes to adsorb mycotoxins (Espacenet Translation [0062]). It would have been obvious to one of ordinary skill in the art to modify Broomhead such that the mass ratio of fragments from lysed cells of Saccharomyces cerevisiae is within the claimed range as taught by Zhu, in order to suitably control mycotoxins (Espacenet Translation [0062]).
Claim 1 differs from Broomhead in the recitation that the additive includes, vitamin C and insoluble fiber and glucose oligosaccharides derived from corn starch.
Dierking discloses that common nutritional supplements for animal food compositions include vitamin C, and grains (grains are insoluble fiber sources) and oligosaccharides ([0027]).
Flickinger discloses known oligosaccharides to feed to animals includes glucose oligosaccharides derived from corn starch (Pg. 1267)
It would have been obvious to modify the pet food additive of Broomhead to include vitamin C, insoluble fiber and oligosaccharides as taught by Dierking and Flickinger in order to enhance the nutrition provided by the pet food additive. It has been held that “Combining prior art elements according to known methods to yield predictable results” supports a conclusion of obviousness (MPEP 2143.I.A).
Claim 1 differs from Modified Broomhead in the recitation that the pet food additive comprises soluble fiber and psyllium fiber.
Stillmann discloses that known ingredients for nutritional composition for animals includes soluble fiber and psyllium (Abstract, [0439], [0443]).
It would have been obvious to modify the pet food additive of Broomhead to include soluble fiber and psyllium fiber as taught by Stillmann in order to enhance the nutrition provided by the pet food additive. It has been held that “Combining prior art elements according to known methods to yield predictable results” supports a conclusion of obviousness (MPEP 2143.I.A).
Regarding the remaining limitation that a mass ratio of said fragments from lysed or partially lysed cells of Saccharomyces cerevisiae to prebiotic material is in the range of 20:1 to 4:1, since the claimed ingredients obviously provide their own nutritional benefit, it would have been obvious to one of ordinary skill in the art to routinely optimize ratio of said fragments to prebiotic material based on the desired nutritional benefit from each individual ingredient (MPEP 2144.05.II).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Broomhead US 2014/0099373 in view of Staeger WO 2007/143093A2 in view of Dikovskiy US 2012/0196811 in view of Zhu CN103243028A (Espacenet Translation) in view of Dierking US 2006/0067985 in view of Flickinger et al. in view of Stillmann US 2007/0009576 in view of Sedmak US 2006/0263415.
Regarding claim 2, claim 2 differs from Modified Broomhead in the recitation that the cell wall fragments specifically have a protein content of 40% or greater.
It is noted that Stager discloses cell wall fragments commonly have a protein content of about 40% (Pg. 10, lines 3-12).
In any case, Sedmak discloses that products obtained from yeast cell autolysis can have 40-45% protein ([0034], Fig. 1, [0024]). Sedmak discloses that the products can be used in animal feeds ([0015]). It would have been obvious to one of ordinary skill in the art to modify the cell wall fragments of Modified Broomhead to specifically have a protein content of 40% or greater as taught by Sedmak in order to increase the nutrition of the supplement of Modified Broomhead.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Broomhead US 20140099373 in view of Staeger WO 2007/143093A2 in view of Dikovskiy US 2012/0196811 in view of Zhu CN103243028A (Espacenet Translation) in view of Dierking US 2006/0067985 in view of Flickinger et al. in view of Stillmann US 2007/0009576 in view of Ridgway US 3,865,691.
Regarding claim 3, Broomhead does not explicitly disclose how the Saccharomyces cerevisiae was grown, however Ridgway discloses that it was conventional in the art to grow yeasts under aerobic conditions (abstract). Therefore, it would have been obvious to one of ordinary skill in the art to modify Broomhead such that the Saccharomyces cerevisiae is grown under aerobic conditions. It has been held that “Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results” supports a conclusion of obviousness.
Response to Arguments
Applicant's arguments filed 07/16/2026 have been fully considered but they are not persuasive.
Applicant argues as a general comment regarding the rejections under 35 U.S.C. 103, it is submitted that the invention is based around a synergistic combination of compounds in specific ratio ranges. Applicant argues that concerning the recited range in claim 1 wherein a dry mass ratio of said cell wall fragments from lysed or partially lysed cells of Saccharomyces cerevisiae to prebiotic material is in the range of 20:1 to 4:1, the Examiner relies on MPEP 2144.05.II to support the rejection. Applicant argues that in the Office Action at paragraph 38, the Examiner provides: "However, since the claimed ingredients obviously provide their own nutritional benefit, it would have been obvious to one of ordinary skill in the art to routinely optimize ratio of said fragments to prebiotic material based on the desired nutritional benefit from each individual ingredient." It is respectfully submitted that the Examiner's "underpinning reasoning" lacks "sufficient detail" to support the rejection, In essence, the rationale is simply stated as desired nutritional benefits from each individual ingredient, which does not address why there is a specific claimed range with respect to only two ingredients claimed. Accordingly, claim 1 should firstly be considered allowable because the prior art does not remotely suggest the claimed range of 20:1 to 4:1 and the Office Action does not articulate why the range is nonobvious in light of the currently cited prior art.
This argument has not been found persuasive. Reliance of routine optimization to support an obviousness rejection is proper where criticality has not been established and currently criticality of the claimed ratios has not been established. Regarding the establishment of criticality of the claimed ratio’s it is noted that MPEP 716.02.(d) requires that “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range”. In this case data has not been provided to show criticality of the claimed ratio of prebiotic material to cell wall fragments as required by MPEP 716.02(d). Therefore the reliance on routine optimization to arrive at the instant invention as used in the obviousness rejection is maintained (MPEP 2144.05.III.A).
Applicant argues that with respect to Zhu disclosing a ratio of yeast cell wall to montmorillonite of 1:9-9:1, it is submitted that this very wide range does not identify any synergistic effect that would enable one skilled in the art to contemplate the much narrower range claimed of 6:1 to 4:1. The Zhu range means that the percentage of cell wall could be either up to 90% or as little as 10%, and the same for montmorillonite. A nine to one reversable ratio cannot be deemed to reasonably teach the claimed range and further considering that there is no reasonable support in the Office Action for the other claimed range of 20:1 to 4:1. These two claimed ranges in combination should be deemed nonobvious in light of the currently cited prior art.
This argument has not been found persuasive. The claimed range is encompassed by that taught by the prior art and therefore is rendered obvious, See MPEP 2144.05.I. “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”
Applicant argues that there are a number of nonobvious and synergistic effects that are achieved by the claimed invention. For example, beginning at [0031] through [0041] of the specification. Applicant argues that considering the exhaustive nonobvious synergistic effects that the rejection of claim 1 should be withdrawn.
While Applicants remarks have been considered, regarding the establishment of criticality of the claimed ratio’s it is noted that MPEP 716.02.(d) requires that “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range”. In this case data has not been provided to show criticality of the claimed ratio of prebiotic material to cell wall fragments as required by MPEP 716.02(d). Therefore the reliance on routine optimization to arrive at the instant invention as used in the obviousness rejection is maintained (MPEP 2144.05.III.A).
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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/A.A/
Ashley AxtellExaminer, Art Unit 1792
/VIREN A THAKUR/Primary Examiner, Art Unit 1792
