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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/05/2025 has been entered.
Claim Amendments
Claims 11 and 36 have been amended to specify that the feed composition is supplemented with “ a direct fed microbial (DFM) and comprising active ingredients selected from i) capsium product ; ii) an antimicrobial clay; iii) formulated yeast, and iv) capscium product and formulated yeast”, that the improving performance “comprises one or more of: an increase of at least 5% in necrotic enteritis lesion score, an improvement of at least 45% in necrotic enteritis related mortality, or any combination thereof compared to an animal not fed the feed composition”, as that the DFM is “Bacillus licheniformis”. Applicant has also canceled claims 31-35, 44, and 46, as well as added claims 47-54. It has been verified that new matter has been added.
Claim Objections
RE: Objection to claims
The deletion of “and” has corrected the minor informality in claim 11.
New objections
Claims 11 and 36 are objected to because of the following informality: the use of a comma before component iv) is inconsistent with the other punctuations separating the alternatives. To resolve this issue, the comma before component iv) should be replaced with a semicolon.
Claim 50 is objected to due to an incorrect spelling in “hot pepper exact”. The term “exact” appears to be a misspelling of “extract”.
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.
Claims 11-13, 45, 47, and 49-54 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 11 and 53-54 require that the improving performance comprises “an increase… in necrotic enteritis lesion score”. Given that lesion scoring is based on a 0 to 3 score, with 0 being normal and 3 being most severe (par. [000106], Specification), an improvement in performance should be indicated by a decrease in lesion score. Thus, an increase in necrotic enteritis lesion score as recited in the claims is confusing as it is opposite to what a performance improvement should entail.
Claims 12-13, 45, 47, and 49-54 are also indefinite for depending on claim 11.
For the purpose of applying prior art, the limitation “an increase… in necrotic enteritis lesion score” is interpreted to mean “an improvement in necrotic enteritis lesion score” (i.e., a decrease in lesion score).
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.
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.
RE: Claims 11-13, 31-35, and 45-46 under 35 U.S.C. 103 as being unpatentable over Lewis et al. in view of Huckaba and Gadde et al.
Applicant traverses the rejections based on the new limitations in claim 11 being not taught by the cited prior art. Lewis et al. allegedly does not demonstrate that the characterized Bacillus strains improve growth performance in an animal and merely mentions using an animal feed composition containing any Bacillus strain to control Clostridium perfringens infections and/or necrotic enteritis without any experimental data, protocols, dosing, etc.. Moreover, Huckaba and Gadde et al. do not cure Lewis et al.’s deficiencies. Referring to work examples, applicant points out that results show birds fed with a feed comprising capsicum, formulated yeast, capsicum with formulated yeast, or B. licheniformis in combination with: capsicum; capsicum and formulated yeast; or antimicrobial clay led to reduction in necrotic enteritis lesion score and necrotic enteritis related mortality compared to challenged control birds.
The traversal has been considered and is found persuasive. It is conceded that Lewis et al. does not specifically teach that administering an animal feed comprising B. licheniformis and one of the recited active ingredients improves performance by improving necrotic enteritis lesion score and/or necrotic enteritis related mortality (as specified in claim 11), nor by decreasing feed conversion rate, increasing body weight gain, or reducing mortality (as specified in claim 36). Hence, the rejections of record have been withdrawn.
An updated search was performed and a new prior art was found that reads on the claimed invention. New grounds of rejection are therefore set forth below.
New rejections
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
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 11-13, 36-40, 42-43, 45, 47-48, and 52-54 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Skinner et al. (Pub. No. US 2012/0244191 A1).
Skinner et al. discloses compositions and methods for treatment of a disease in animals such as poultry. One embodiment of the composition comprises B. licheniformis spores, Saccharomyces cerevisiae yeast extract, and optionally a carrier (par. [0011]), wherein said yeast extract comprises glucans and mannans from yeast cell walls (par. [0014], [0016], [0024]).
To prepare for use, Skinner et al. teaches adding the disclosed composition to an animal foodstuff and then administering the resulting mixture to an animal (par. [0028]).
In a working example, broiler chicks were fed for 28 days with feedstuff comprising a direct fed microbial product (DFM) containing B. licheniformis spores at a rate of 0.5 lb per ton (AlCare 0.5 group) or 1.0 lb per ton (AlCare 1 group), a S. cerevisiae extract at a rate of 1 lb per ton (Alphamune 1 group) or 2 lbs per ton (Alphamune 2 group), or combinations of said spores and extract (par. [0031]-[0032]). All of the broiler chicks were challenged with Eimeria maxima on day 14 and with C. perfringens on days 19, 20, and 21 except for a control group. Results demonstrate that administering feedstuff comprising B. licheniformis spores and S. cerevisiae extract decreased both necrotic enteritis lesion score and necrotic enteritis mortality compared to the challenged control (Table 1, page 4).
In another working example, challenged chicks fed for 42 days with feedstuff comprising B. licheniformis spores and S. cerevisiae extract, at a rate of 1.0 lb per ton each, led to increased average weight gain, decreased feed conversion ratio, reduced necrotic enteritis lesion score, and necrotic enteritis mortality relative to the challenged control (Tables 3-5, page 5).
Skinner et al. reads on the instant application’s methods for improving performance of non-human animals as follows: Regarding claim 11: feeding animals like broiler chicks, which are non-human, with feedstuff is the same as “feeding the non-human animal a feed composition”.
The feedstuff containing a DFM comprising B. licheniformis is equivalent to “a feed composition comprising a basal animal diet supplemented with a direct fed microbial (DFM)” and meets the limitation “wherein the DFM is Bacillus licheniformis”.
The feedstuff also comprising an extract of S. cerevisiae is identical to “and comprising active ingredients selected from… (iii) formulated yeast”.
The finding that administering the feedstuff comprising B. licheniformis spores and S. cerevisiae extract decreased necrotic enteritis lesion score by as much as 74.8% in Example 1 (“AlCare 1 + Alphamune 1” vs. “Challenged Control” in Table 1, page 4) and 53.8% in Example 3 (“AA, CP” vs. “Challenged Control (CP)” in Table 4, page 5) compared to the challenged control, as well as necrotic enteritis related mortality by as much as 90.0% in Example 1 (“AlCare 1 + Alphamune 1” vs. “Challenged Control” in Table 1, page 4) and 61.5% in Example 3 (“AA, CP” vs. “Challenged Control (CP)” in Table 5, page 5), satisfies “wherein the improving performance comprises one or more of: an increase of at least 5% in necrotic enteritis lesion score, an improvement of at least 45% in necrotic enteritis related mortality, or any combination thereof compared to an animal not fed the feed composition”.
Regarding claim 12: the feedstuff comprising B. licheniformis spores and S. cerevisiae extract was found to increase average weight gain (Table 3, page 5) and decrease feed conversion ratio (Table 4, page 5) after 42 days of administration, thereby fulfilling “further comprises an increase in body weight gain, a decrease in feed conversion rate (FCR), an increase in average daily weight gain (ADG), an increase in average daily food intake (ADFI), or any combination thereof”.
Regarding claim 13: the broiler chick as the animal being fed in the working examples corresponds to “wherein the non-human animal is a chicken, and wherein the feed composition is fed to said chicken at a growth-phase selected from the group consisting of a starter, a grower, and a finisher”.
Regarding claim 36: feeding animals like broiler chicks with feedstuff containing a DFM comprising B. licheniformis is the same as “feeding the non-human animal a feed composition comprising a basal animal diet supplemented with a direct fed microbial (DFM)”.
The feedstuff also comprising yeast extract meets “and comprising active ingredients selected from… (iii) formulated yeast”.
Example 3’s results of average weight gain increase of 9.1% and feed conversion ratio decrease of 6.3 % compared to the challenged control (“AA, CP” vs. “Challenged Control (CP)” in Tables 3-4, page 5) read on “wherein the improving performance comprises a decrease in feed conversion rate (FCR) of at least 2.79% compared to an animal not fed the feed additive composition, or wherein the improving performance comprises an increase of body weight gain of at least 2.71% compared to an animal not fed the feed additive composition…”.
The reduction in necrotic enteritis related mortality by as much as 90.0% in Example 1 (“AlCare 1 + Alphamune 1” vs. “Challenged Control” in Table 1, page 4) and 61.5% in Example 3 (“AA, CP” vs. “Challenged Control (CP)” in Table 5, page 5) read on “…or wherein the improving performance comprises a reduced mortality of at least 10% compared to an animal not fed the feed additive composition”.
Regarding claim 37: the average weight gain increase of 9.1% compared to the challenged control satisfies “wherein improving performance comprises an increase of body weight gain of at least 2.71% compared to an animal not fed the feed additive composition”.
Regarding claim 38: the enteritis related mortality reduction by as much as 90.0% in Example 1 (“AlCare 1 + Alphamune 1” vs. “Challenged Control” in Table 1, page 4) and 61.5% in Example 3 (“AA, CP” vs. “Challenged Control (CP)” in Table 5, page 5) fulfills “wherein improving performance comprises a reduced mortality of at least 10% compared to an animal not fed the feed additive composition”.
Regarding claim 39: the feed conversion ratio decrease of 6.3% compared to the challenged control meets “wherein improving performance comprises a decrease in feed conversion rate (FCR) of at least 2.79% compared to an animal not fed the feed additive composition”.
Regarding claim 40: the animal fed with the feedstuff being a broiler chick is akin to “wherein the non-human animal is a chicken, and wherein the feed composition is fed to said chicken at a growth-phase selected from the group consisting of a starter, a grower, and a finisher”.
Regarding claims 42 and 45: the necrotic enteritis lesion score decrease of 40% in Example 1 (“AlCare 0.5 + Alphamune 1” vs. “Challenged Control” in Table 1, page 4) and 53.8% in Example 3 read on (“AA, CP” vs. “Challenged Control (CP)” in Table 4, page 5) compared to the challenged control “wherein the feed composition improves the necrotic enteritis lesion score by about 5% to about 60%”.
Regarding claims 43 and 52: the enteritis related mortality reduction by as much as 90.0% in Example 1 and 61.5% in Example 3 satisfies “wherein the feed composition improves necrotic enteritis related mortality by about 45% to about 100%” and “…by about 65% to about 100%”, respectively.
Regarding claims 47-48: the feedstuff being fed for 28 days or 42 days fulfills “wherein the feed composition is fed to the non-human animal at a growth period of between: i) day 0 and day 14; ii) day 14 and day 28; iii) day 28 and day 41, or iv) day 0 and day 41”.
Regarding claim 53: the decrease in necrotic enteritis lesion score by as much as 74.8% in Example 1 and 53.8% in Example 3 compared to the challenged control meets “wherein the improving performance comprises an increase of at least about 10% in necrotic enteritis lesion score”. As set forth above (rejection under 35 U.S.C. 112), the term “an increase… in necrotic enteritis lesion score” is interpreted to refer to “an improvement… in necrotic enteritis lesion score” (i.e., a decrease in lesion score).
Regarding claim 54: the decrease in necrotic enteritis related mortality by as much as 90.0% in Example 1 and 61.5% in Example 3 satisfies “wherein the improving performance comprises an increase of at least about 50% in necrotic enteritis related mortality”.
Claims 11-13, 36-40, 42-43, 45, 47-49, and 52-54 are rejected under 35 U.S.C. 103 as being unpatentable over Skinner et al. (Pub. No. US 2012/0244191 A1).
Skinner et al.’s teachings are set forth above and applied herein. Claims 11-13, 36-40, 42-43, 45, 47-48, and 52-54 are anticipated by Skinner et al..
The prior art is comparable to the claim below:
Regarding claim 49: the broiler chicks in the “AlCare 1 + Alphamune 1” group were given feedstuff comprising DFM, wherein the DFM contains 1010 spores of B. licheniformis per gram in a calcium carbonate carrier that provides 2.2 x 109 CFU per lb of feed (par. [0015]). Since the DFM was fed to said group at a rate of 1 lb per ton (par. [0031]), the feedstuff is estimated to contain 4.8 x 106 CFU of B. licheniformis per gram of feed.
The disclosed amount of 4.8 x 106 CFU is not identical to “wherein the Bacillus licheniformis in the feed composition is at a concentration of about 1x104 cfu/g to about 1x106 cfu/g in the feed composition”.
Nonetheless, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., "not substantially less than 13%," "not substantially below 17%," and "between about 13[%] and 20%"). And in this case, applicant has not shown that amounts close to the claimed concentration range would not be effective in improving necrotic enteritis lesion score or necrotic enteritis related mortality.
Claim 49 is therefore obvious over Skinner et al..
Claims 11-13, 36-40, 42-43, 45, 47-48, 50, and 52-54 are rejected under 35 U.S.C. 103 as being unpatentable over Skinner et al. (Pub. No. US 2012/0244191 A1) view of Lillehoj et al. (BMC Proceedings 2011, Vol. 5, Article S34, pages 1-8).
The teachings of Skinner et al. are described previously and applied herein. Claims 11-13, 36-40, 42-43, 45, 47-48, and 52-54 are anticipated by Skinner et al..
Skinner et al. is similar to the following claim:
Regarding claim 50: the Capsicum product in the method of claim 11 is further required to be “selected from the group consisting of a capsaicinoid, a vanilloid, Capsicum, macerated hot peppers, ground hot peppers, hot pepper exact, capsaicin-containing plant materials, encapsulated ground peppers, a coated capsaicin product, and any combinations thereof”.
Skinner et al. is different from the instant claim in that the disclosed composition does not contain a Capsicum product.
According to Lillehoj et al., plant-derived products are used as feed supplements to enhance immunity to diseases (right col., page 1). One of these plant-derived products is Capsicum oleoresin, which is prepared through organic extraction of pepper fruits (i.e., hot pepper extract) and contains capsaicin that has antibacterial activity (first par. in left col., page 2). Lillehoj et al. investigated the effects of Capsicum oleoresin on the regulation of the expression of genes associated with immunology, physiology, and metabolism in chickens using high-throughput microarray analysis. Results revealed that Capsicum oleoresin induced various gene changes compared to the control group and many of these genes were associated with metabolism and immunity such as citrate cycle, glyoxylate and dicarboxylate metabolism, and glycolysis/gluconeogenesis (Abstract, page 1; Figure 2, page 3). Feeding Eimeria acervulina-challenged broiler chickens with Capsicum oleoresin along with carvacrol and cinnamaldehyde improved body weight gain and reduced oocyst shedding (Figure 4, page 6).
A person with ordinary skill in the art before the effective filing date of the claimed invention would have been motivated by Lillehoj et al. to add Capsicum oleoresin to Skinner et al.’s feedstuff with reasonable expectation that it would help control bacterial infection and promote health of chickens. Some teaching, suggestion, or motivation in the prior art would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Hence, claim 50 is obvious over Skinner et al. in view of Lillehoj et al..
Claims 11-13, 36-40, 42-43, 45, 47-48, and 51-54 are rejected under 35 U.S.C. 103 as being unpatentable over Skinner et al. (Pub. No. US 2012/0244191 A1) in view of Huckaba (Pub. No. WO 2017/173393 A1) and Gadde et al. (Animal Health Research Reviews 2017, Vol. 18, pages 26-45).
The teachings of Skinner et al. are described previously and applied herein. Claims 11-13, 36-40, 42-43, 45, 47-48, and 52-54 are anticipated by Skinner et al..
Skinner et al. is similar to the following claim:
Regarding claim 51: the antimicrobial clay in the method of claim 11 is further specified to be present “at a concentration of about 2 lb./ton (1 g or 0.1% w/w) to about 6 lb./ton (3 g or 0.3% w/w)”.
Skinner et al. differs from the instant claim in that the composition used in the disclosed method does not have an antimicrobial clay.
Huckaba, however, teaches preparing a bioactive clay as a feed supplement and administering it to domesticated animals in order to improve their growth and/or health (Abstract). Also referred to as “antibacterial clay”, the bioactive clay is a composition of an aluminum phyllosilicate mineral that includes iron in a reduced state (lines 21-23, page 3). One example of a suitable bioactive clay is Oregon Blue clay, which is a montmorillonite smectite and possesses antibacterial property (lines 15-16, page 2; lines 29-30, page 4; lines 14-18, page 5). Huckaba teaches that a composition comprising Oregon Blue Clay can be administered to domesticated animals to improve growth such as by gaining weight and/or to improve the health of the domesticated animals such as by increasing feed intake, enhancing feed conversion ratio, decreasing morbidity, and reducing prevalence and/or burden of bacterial pathogens (lines 19-31, page 11). Similarly, Gadde et al. teaches that clay minerals or phyllosilicates were previously found not only to exhibit antibacterial activity in poultry but also improve growth performance and body weight gain in 1-week and 3-week old chickens (second paragraph in right col., page 35).
Since antimicrobial clays are known to give various health benefits to animals and have been incorporated into animal feeds as shown by Huckaba and Gadde et al., one with ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Skinner et al.’s method by adding an antimicrobial clay like Oregon Blue clay to the disclosed animal feed composition and feeding the resulting feed composition to animals. It can be predicted that antimicrobial clay supplementation would enhance the animal’s growth and/or health. Obviousness is based on the rationale that some teaching, suggestion, or motivation in the prior art would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Claim 51 is thus obvious over Skinner et al. in view of Huckaba and Gadde et al..
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651