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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on 02 September 2025 is acknowledged.
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.
Claim 7 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.
Claim 7 recites the limitation "the stabilized pH" in lines 2-23. 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.
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 1-2, 4-8, 10-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kiarie et al. (herein referred to as Kiarie, WO 2017083196 A1) in view of Lopez et al. (herein referred to Lopez, “Digestible and metabolizable energy in soybean meal sourced from different countries and fed to pigs”).
With regard to Claim 1, Kiarie teaches a diet comprising a feed additive comprising a protease (abstract). The feed comprises soybean meal (page 41, table 1). Kiarie teaches the composition contains 5.97% acid detergent fiber (page 41, table 1) but is silent to the content of acid detergent fiber in the soybean meal.
The acid detergent fiber content in soybean meal can be adjusted through routine optimization as taught by Lopez. Lopez teaches the acid detergent fiber content in soybean meal varies based on the country of origin of the soybean meal (page 4, table 3). Lopez teaches soybean meal from China and India have an acid detergent fiber content greater than about 56 g/kg (page 4, table 3).
Therefore, through routine optimization the acid detergent fiber content within the soybean meal can be optimized based on the location of origin of the soybean meal. See MPEP 2144.05(II) "[W]here 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 regard to Claim 2, Kiarie teaches at least one protease that is a subtilisin, a bacillolysin, an alkaline serine protease, a keratinase or a Nocardiopsis protease (page 2. Lines 21-22).
With regard to Claim 4, Kiarie teaches the composition contains 5.97% acid detergent fiber (page 41, table 1) but is silent to the content of acid detergent fiber in the soybean meal.
The acid detergent fiber content in soybean meal can be adjusted through routine optimization as taught by Lopez. Lopez teaches the acid detergent fiber content in soybean meal varies based on the country of origin of the soybean meal (page 4, table 3). Lopez teaches soybean meal from China and India have an acid detergent fiber content greater than about 56 g/kg (page 4, table 3).
Therefore, through routine optimization the acid detergent fiber content within the soybean meal can be optimized based on the location of origin of the soybean meal. See MPEP 2144.05(II) "[W]here 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 regard to Claim 5, the limitations of this claim are directed towards an embodiment in claim 1 wherein (a) is satisfied. However, because claim 1 only requires (a) to be satisfied in the alternative and because claim 5 does not positively recite the presence of the sulfur containing content of the soybean meal (i.e. limitation (b)), the limitations of claim 5 are not required in the embodiment in which only (a) is satisfied. As such, since the art teaches the limitations of claim 1, the scope of claim 5 is rendered obvious.
With regard to Claim 6, the limitations of this claim are directed towards an embodiment in claim 1 wherein (a) is satisfied. However, because claim 1 only requires (a) to be satisfied in the alternative and because claim 5 does not positively recite the majority of particles comprising less than 1 mm in size (i.e. limitation (c)), the limitations of claim 6 are not required in the embodiment in which only (a) is satisfied. As such, since the art teaches the limitations of claim 1, the scope of claim 6 is rendered obvious.
With regard to Claims 7 and 8, the limitations of these claims are directed towards an embodiment in claim 1 wherein (a) is satisfied. However, because claim 1 only requires (a) to be satisfied in the alternative and because claim 5 does not positively recite the low buffering capacity (i.e. limitation (d)), the limitations of claims 7 and 8 are not required in the embodiment in which only (a) is satisfied. As such, since the art teaches the limitations of claim 1, the scope of claims 7 and 8 is rendered obvious. See applicants specification paragraph 56 showing the limitations of claims 7 and 8 are directed towards claim 1 (d).
With regard to Claim 10, Kiarie teaches he feed additive composition further comprises one or more direct fed microbials (DFMs) (page 2. Lines 1-4).
With regard to Claim 11, Kiarie teaches the DFM comprises bacteria from Lactobacillus, Lactococcus, Streptococcus, Bacillus, Pediococcus, Enterococcus, Leuconostoc, Carnobacterium, Propionibacterium, Bifidobacterium, Clostridium and Megasphaera and combinations thereof (page 2. Lines 6-9).
With regard to Claim 12, Kiarie teaches the DFM comprises a bacterium from one or more of the following species; Bacillus subtilis, Bacillus licheniformis, Bacillus pumilus, Bacillus amyloliquefaciens, Enterococcus, Enterococcus spp, and Pediococcus spp, Lactobacillus spp, Bifidobacterium spp, Lactobacillus acidophilus, Pediococsus acidilactici, Lactococcus lactis, Bifidobacterium bifidum, Propionibacterium thoenii, Lactobacillus farciminus, lactobacillus rhamnosus, Clostridium butyricum, Bifidobacterium animalis ssp. animalis, Lactobacillus reuteri, Bacillus cereus, Lactobacillus salivarius ssp. salivarius, Megasphaera elsdenii, Propionibacteria sp and combinations thereof. (page 2. Lines 10-17).
With regard to Claim 15, Kiarie teaches a method for formulating a diet for an animal (abstract). The method comprising combining a protease with a soybean meal (page 41, table 1-table 2). Kiarie teaches the composition contains 5.97% acid detergent fiber (page 41, table 1) but is silent to the content of acid detergent fiber in the soybean meal.
The acid detergent fiber content in soybean meal can be adjusted through routine optimization as taught by Lopez. Lopez teaches the acid detergent fiber content in soybean meal varies based on the country of origin of the soybean meal (page 4, table 3). Lopez teaches soybean meal from China and India have an acid detergent fiber content greater than about 56 g/kg (page 4, table 3).
Therefore, through routine optimization the acid detergent fiber content within the soybean meal can be optimized based on the location of origin of the soybean meal. See MPEP 2144.05(II) "[W]here 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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kiarie (WO 2017083196 A1) in view of Lopez ( “Digestible and metabolizable energy in soybean meal sourced from different countries and fed to pigs”) and Basler et al. (herein referred to as Basler, US 20150064767 A1)
With regard to Claim 3, Kiarie teaches using proteases of animal, vegetable or microbial origin and that chemically modified or protein engineered mutant proteases can also be used (page 14. Lines 19-20). Bur Kiarie is silent to the protease specifically being 80% identical to SEQ ID NO:1.
Basler teaches compositions comprising variant microbial protease (title) wherein the compositions can be used in feed ([0014]). Basler teaches in one embodiment the protease is substantially identical to SEQ ID NO:1 of the instant claim (page 29 SEQ ID NO 1, see applicants specification paragraph [0062]) as well as numerous variants ([0005]-[0010]). Basler teaches the variant proteases can have various applications where degradation or synthesis of polypeptides is desired ([0016]).
Basler imparts reasoning for obviousness because the teaching shows that the claimed protease was known for being successfully used in animal feed and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select the protease taught by Basler, 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 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Additionally, it would be advantageous to modify Kiarie in view of Basler to utilize the protease taught by Basler to degrade or synthesize the polypeptides desired.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kiarie (WO 2017083196 A1) in view of Lopez ( “Digestible and metabolizable energy in soybean meal sourced from different countries and fed to pigs”) and Millan (US 20140234279 A1)
With regard to Claim 9, Kiarie is silent to the feed additive composition further comprises one or more additional enzymes selected from the group consisting of a xylanase, amylase, phytase, glucoamylase, pectinase, mannanase, and β-glucanase.
Millan teaches a feed additive composition comprising a direct fed microbial in combination with a protease, a xylanase, an amylase, and a phytase (abstract). Millan direct fed microbials in combination with a protease, xylanase, amylase and phytase has significant beneficial effects on the performance of an animal ([0005]).
Therefore, because Kiarie teaches a feed additive with a protease and direct fed microbials (page 2. Lines 1-4) it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Kiarie to include , xylanase, amylase, and phytase as taught by Millan to provide significant beneficial effects on the performance of an animal.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kiarie (WO 2017083196 A1) in view of Lopez ( “Digestible and metabolizable energy in soybean meal sourced from different countries and fed to pigs”) and Knight et al. (herein referred to as Knight, US 20140248258 A1).
With regard to Claims 13 and 14, Kiarie is silent to the feed additive composition further comprises one or more essential oils wherein the essential oil is thymol and/or cinnamaldehyde.
Knight teaches a method of administering a supplement to a subject consisting of essentially at least one protease to improve gut health, wherein the subject may be food animals, companion animals, research animals, and zoo animals (abstract, [0059]). Knight teaches the composition may include thymol which acts as an antioxidant ([0070]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Kiarie in view of Knight to include an essential oil such as thymol in the composition to act as an antioxidant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARLA I DIVIESTI whose telephone number is (571)270-0787. The examiner can normally be reached Monday-Friday 7am-3pm (MST).
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792