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 Status
Claims 1-6 and 9-15 are currently pending in the application. Claims 7-8 and 32-36 are cancelled.
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 1 and 15 are 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.
With regard to Claims 1 and 15, the claims use the phrase “one or more” prior to listing elements (a)-(d) which are separated by an “and” rather than an “and/or” statement. Therefore, it is unclear if the claim requires all (a)-(d) elements or if one or more of elements (a)-(d) is sufficient to satisfy the claim requirements. Therefore one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 2-6 and 9-14 are rejected due to their dependency on the above rejected claims.
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 1-2, 4-6, 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”), Dunkley et al. (herein referred to as Dunkley, “The Amino Composition of Organic Soybean Meal for the Formulation of Organic Poultry Feed”), and Suiryanrayna et al. (herein referred to as Suiryanrayna, “A review of the effects of dietary organic acids fed to swine”)
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 is ground to a suitable particle size (page 24 lines 21-22). Kiarie teaches one embodiment wherein the particles are ground to a size that fits through a 1-mm screen (page 42 lines 22-23). Thus Kiarie reads such that majority of the particles are less than 1mm in size. 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).
In addition, Kiarie teaches the composition contains soybean meal but is silent to the sulfur-containing amino acid content.
Dunkley teaches soybean meal used in poultry feed and the amino acid content in organic soybean meal and compared it to the amino acid content in conventionally-grown soybean meal (paragraph 5). Dunkley teaches conventional soybean meal contains 0.66% cysteine and 0.62% Methionine (table 1). One with ordinary skill in the art would recognize cysteine and methionine are the only sulfur-containing amino acids. Therefore, conventional soybean meal contains 1.28% sulfur-containing amino acids. Its important to note that 13 g/kg can be expressed as 1.3%. Thus Dunkley reads such that the sulfur-containing amino acids content of conventional soybean meal is less than 13 g/kg. 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.
Therefore Dunkley imparts reasoning for obviousness because the teaching shows that soybean meal containing less than 13 g/kg of sulfur containing amino acids was known to be 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 selected soybean meal containing less than 13 g/kg of sulfur containing amino acids for used in animal feed 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.
Lastly, Kiarie is silent to the low buffer capacity.
Suiryanrayna teaches the effects of dietary organic acids fed to swine (title). Suiryanrayna teaches that acidifiers improve gut health by promoting the beneficial bacterial growth while inhibiting the growth of pathogens through the reduction of pH and buffering capacity of the diets. The reduced buffering capacity of the diets containing organic acids reduces the colonization of undesirable microbes (Inhibition of pathogenic bacteria).
Therefore, 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 so the feed has a low buffering capacity to reduce the colonization of undesirable microbes. In addition it would have been obvious through routine experimentation to achieve a buffer capacity such that less than 0.44 mol/kg HCl would need to be added to a 10% suspension of the feed to reach of pH-value of 4.0 based on the desire of scientists or artisans to improve upon what is already generally known. See MPEP 2144.05(II)(A) "[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." 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, Kiarie teaches the composition contains soybean meal but is silent to the sulfur-containing amino acid content.
Dunkley teaches soybean meal used in poultry feed and the amino acid content in organic soybean meal and compared it to the amino acid content in conventionally-grown soybean meal (paragraph 5). Dunkley teaches conventional soybean meal contains 0.66% cysteine and 0.62% Methionine (table 1). One with ordinary skill in the art would recognize cysteine and methionine are the only sulfur-containing amino acids. Therefore, conventional soybean meal contains 1.28% sulfur-containing amino acids. It’s important to note that 13 g/kg can be expressed as 1.3%. Thus Dunkley reads such that the sulfur-containing amino acids content of conventional soybean meal is less than 13 g/kg. 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. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.
Therefore Dunkley imparts reasoning for obviousness because the teaching shows that soybean meal containing less than 13 g/kg of sulfur containing amino acids was known to be 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 selected soybean meal containing less than 13 g/kg of sulfur containing amino acids for used in animal feed 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.
With regard to Claim 6, Kiarie teaches one embodiment wherein the particles are ground to a size that fits through a 1-mm screen (page 42 lines 22-23). Thus Kiarie reads such that majority of the particles are less than 1mm in size.
With regard to Claim 10, Kiarie teaches the 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”), Dunkley ( “The Amino Composition of Organic Soybean Meal for the Formulation of Organic Poultry Feed”), and Suiryanrayna ( “A review of the effects of dietary organic acids fed to swine”) 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”), Dunkley ( “The Amino Composition of Organic Soybean Meal for the Formulation of Organic Poultry Feed”), and Suiryanrayna ( “A review of the effects of dietary organic acids fed to swine”) 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”), Dunkley ( “The Amino Composition of Organic Soybean Meal for the Formulation of Organic Poultry Feed”), and Suiryanrayna ( “A review of the effects of dietary organic acids fed to swine”) 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6 and 9-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.I.D./ Examiner, Art Unit 1792
/ERIK KASHNIKOW/ Supervisory Patent Examiner, Art Unit 1792
Prosecution Insights