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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/20/2026 is in compliance with the provisions of 37 C.F.R. 1.97. All references cited in this IDS have been fully considered.
Amendments
Claim 17 requires the method to provide an improvement of an average daily weight gain (ADWG) of at least 3% wherein the ADWG of at least 3% is observed at least 25 days after feeding said broiler chickens.
Claim 19 now depends from claim 44.
Claim 22 requires the method to provide an improvement of ADWG observed at least 25 days after feeding said broiler chickens.
Claims 25-26 now depend from claim 45.
Claims 37, 39, 42, and 43 are canceled.
Claims 40-41 now depend from claim 44.
Claims 44-45 are newly added and require the method to further provide an improvement of average daily live weight gain.
Claims 46-47 are newly added and require the chickens to be fed for at least 25 days.
Claim Status
Claims 17-19, 22-26, 32-36, 38, 40-41, and 44-47 are currently pending and have been examined on their merits.
Claim Objections
Claims 17, 22, 32-33, and 46-47 are objected to because they contain unitalicized taxonomic names. In general, the names of taxonomic genera and species should be italicized.
Appropriate correction is required.
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.
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.
Previous rejections under 35 U.S.C. § 102/103
RE: Rejection of claims 17-19, 22-26, and 32-43 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Rehberger et al. (US 10,201,574 B1).
Rejection under 35 U.S.C. § 102(a)(1)/102(a)(2)
Claims 37, 39, 42, and 43 are canceled, rendering their rejection moot. With respect to the rejection of claims 17-19, 22-26, 32-36, 38, and 40-41, applicant traverses the rejection by arguing that the amended claims now require an improvement observed at least 25 days after feeding the broiler chickens. Applicant argues the following:
First, applicant asserts that Rehberger does not describe this feature because the maximum number of days with results described by Rehberger is 14 days.
Second, applicant asserts that Rehberger does not inherently describe this component because inherency requires that the characteristic necessarily flows from the teachings of the applied prior art. To support this argument, applicant points to the specification which shows that improvements in average daily weight gain (ADWG) were not observed each and every time past 14 days. For example, in Table 16, ADWG did not demonstrate an improvement between study days 11-25.
Rejection under 35 U.S.C. § 103
Third, applicant argues that the amended claims are not prima facie obvious because Rehberger does not inherently provide for the limitations of amended claims 17 and 22 and the teachings of Rehberger express or inherent do not teach or suggest the ADWG improvements that are observed at least 25 days after feeding the broiler chickens because poultry growth follows a non-linear pattern and improvements quantified at the end of the first 14 days do not imply proportional gains later.
Applicant’s arguments have been fully considered but are not sufficient to overcome the rejections over Rehberger for the following reasons.
Rehberger teaches methods of administering one or more Bacillus strains to poultry which improve bacterial homeostasis in the gastrointestinal tract by inhibiting bacterial pathogens such as E. coli and Clostridium (abstract). Rehberger concludes that administering the Bacillus strains also improves performance such as weight gain and feed conversion (abstract). Rehberger teaches that Clostridium perfringens causes infection in poultry and C. perfringens-associated necrotizing enteritis can have a significant impact on commercial poultry operations as “it increases mortality and decreases weight gain of chickens and turkeys” (col. 17, lines 49-67). Rehberger teaches Bacillus subtilis 747 as one of the five strains isolated and “selected for their antimicrobial properties against Clostridium perfringens and avian pathogenic E. coli” (col. 17, lines 63-67). Rehberger teaches that Bacillus subtilis 747 was selected for its antimicrobial properties and “commercialized for use as DFM in poultry feed” (col. 23, lines 2-8). Thus, Rehberger isolated, characterized, and commercialized Bacillus subtilis 747 for the purpose of preventing necrotizing enteritis and APEC and for improving weigh gain and feed conversion of broiler chickens.
And although it is acknowledged that Rehberger does not directly describe an improvement of an ADWG of at least 3% wherein the ADWG of at least 3% is observed at least 25 days after feeding said broiler chickens, this feature must inherently follow from the teachings of Rehberger because Rehberger teaches methods of administering the same composition to the same subject for the same purpose.
“"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)(MPEP § 2112(I)).
Although it is acknowledged that applicant argues inherency is not present because “[t]he fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic” (MPEP § 2112(IV); emphasis in MPEP), inherency is present in this case because the differences between the prior art method and the instantly claimed methods does not require optimization of conditions and Rehberger teaches “more than a broad genus of potential applications” (Id.) because it teaches the exact effect observed by applicant. Rehberger directly teaches an improvement in daily weight gain using the exact composition used in applicant’s methods and administration to the exact same population. Thus, the broiler chickens in Rehberger’s methods must have had an improvement of an ADWG of at least 3% wherein the ADWG of at least 3% is observed at least 25 days after feeding said broiler chickens.
Rehberger is not directed merely to improving weight gain at 14 days of life but is clearly directed to improving weight gain in poultry operations (i.e., over a period of time longer than 14 days). This position is supported by the following teachings in Rehberger:
“A reduction in the levels of APEC strains will reduce rates of disease and have a positive effect on the productivity of commercial broiler operations” (col. 2, lines 8-11).
“In accordance with another embodiment of the present invention, administering said strain or strains to said animal improves average daily weight gain relative to that in animals that have not been administered the strain or strains” (col. 4, lines 11-14).
Rehberger is not required to assess the average daily weight gain over every time point (such as by quantifying the ADWG every day from birth until commercial operation slaughter) in order to teach (under the inherency standard of 35 U.S.C. § 102) or suggest (under 35 U.S.C. § 103) the claimed invention. Rejection under 35 U.S.C. § 102 and 103 is appropriate because, as discussed in MPEP § 2112(III), “where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103” and “[t]his same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic” (MPEP § (III); emphasis added). For at least this reason, the rejection of record is proper and the same standard has been applied to the rejection over the amended claims.
In summary, applicant’s methods are identical to Rehberger’s (i.e., are directed to the same purpose with the same composition and to the same subject) with the exception that they involve recitation of specific properties inherent to Rehberger’s methods. Merely reporting what Rehberger’s method does over an additional 11 days (25 days versus 14 days) does not overcome its teachings.
In order to full respond to applicant’s amendments, the rejection of record is withdrawn and a new ground of rejection is made below.
New ground of rejection under 35 U.S.C. § 102/103
Claims 17-19, 22-26, 32-36, 38, 40-41, and 44-45 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Rehberger et al. (US 10,201,574 B1).
Rehberger discloses methods of administering one or more Bacillus strains to poultry (abstract). Rehberger teaches that conventionally, poultry production uses antibiotics to prevent disease and stimulate animal growth (col. 1, lines 28-29). Bacteriocins (antimicrobial peptides produced by bacteria) are alternatives to common antibiotics in livestock production (col. 2, lines 38-40). Rehberger teaches that “what is needed are bacterial strains and combinations of bacterial strains that are bacteriocin producing as to be useful in poultry and other animals” (col. 2, lines 65-67).
Regarding claims 17 and 22, Rehberger teaches a method for inhibiting a pathogen in an avian animal comprising administering to an animal an effective amount of Bacillus subtilis strain 747 (col. 4, lines 3-8; claim 1) wherein administering said strain to said avian improves average daily weight gain and feed conversion (abstract; col. 4, lines 11-14; claim 4). Rehberger teaches that “feeding or dosing one or more Bacillus strains described herein reduces bacterial pathogens of poultry, improves immune and gut barrier function and GI microbial homeostasis resulting in improved health and performance in poultry” (col. 6, lines 59-63).
With respect to the avian animal being a broiler chicken, Rehberger teaches that the method is effective when administered to broiler chickens (col. 3, line 66 through col. 4, line 2)
With respect to the strain being the active ingredient, although Rehberger does not explicitly use this terminology, because the strain is the component of the composition causing the effect of improving weight gain and feed conversion, it is considered to be the active ingredient.
Thus, Rehberger teaches a method of feeding broiler chickens, comprising feeding said broiler chickens an amount of a feed having an active ingredient comprising Bacillus subtilis strain 747.
With respect to improving ADWG over the time period recited in the claim, although Rehberger does not specifically teach the claimed percentages of changes to ADWG or the specific timeframe recited in the claims, Rehberger teaches that administering the strains improves average daily weight gain and feed conversion (abstract). The claimed effect on ADWG is a predictable characteristic inherent to the administration of Bacillus subtilis strain 747 to broiler chickens. Because the claim is to a method of feeding broiler chickens and the Bacillus subtilis strain 747 is merely administered in an amount to provide at least one of the claimed effects, Rehberger’s disclosure is sufficient to anticipate the claim as there is no requirement that a person having ordinary skill in the art would have recognized the inherent disclosure at the time of publication. Rehberger teaches that this strain is capable of affecting daily weight gain and feed conversion. Thus, the discovery of the specific percentages of change in these parameters (or specific points of time at which these percentages occur) does not render the old process patentably new (MPEP § 2112(I) and (II)).
Alternatively, even if Rehberger does not explicitly teach the claimed parameter, a person having ordinary skill in the art would have routinely experimented with various amounts of B. subtilis 747 to achieve an ADWG of at least 3% (or, more broadly in the case of claim 22, any amount of improvement) and could have done so over an arbitrary time period range such as “at least 25 days”. It would have been obvious to have experimented with the dosage of B. subtilis 747 for this purpose because Rehberger teaches that this strain improves weight gain and feed conversion and because Rehberger’s disclosure is in the context of providing alternatives to antibiotics in commercial broiler operations (col. 1, line 28 through col. 3, line 4). Thus, the teachings of Rehberger are clearly directed to outcomes extending beyond the 14 days tested in Example 10 of Rehberger’s disclosure and it would have therefore been obvious to have observed an improvement over another longer time period such as at least 25 days.
Thus, claims 17 and 22 are anticipated by or, alternatively, obvious over Rehberger.
Regarding claims 44-45, as discussed above Rehberger anticipates or, alternatively, renders obvious the method of claims 17 and 22 and the recited parameter (improvement in ADWG) is considered to be inherent to Rehberger’s disclosure.
With respect to improving ADLWG, although Rehberger does not specifically teach the claimed percentages of changes to ADLWG or the specific timeframe recited in the claim, Rehberger teaches that administering the strains improves weight gain and feed conversion (abstract). The claimed effect on ADLWG is a predictable characteristic inherent to the administration of Bacillus subtilis strain 747 to broiler chickens. Because the claim is to a method of feeding broiler chickens and the Bacillus subtilis strain 747 is merely administered in an amount to provide the claimed effect, Rehberger’s disclosure is sufficient to anticipate the claim as there is no requirement that a person having ordinary skill in the art would have recognized the inherent disclosure at the time of publication. Rehberger teaches that this strain is capable of affecting weight gain and feed conversion. Thus, the discovery of the specific percentages of change in ADLWG (or specific points of time at which these percentages occur) does not render the old process patentably new (MPEP § 2112(I) and (II)).
Alternatively, even if Rehberger does not explicitly teach the claimed parameter, a person having ordinary skill in the art would have routinely experimented with various amounts of B. subtilis 747 to achieve an ADLWG of at least 1% and could have done so over an arbitrary time period range such as “at least 25 days”. It would have been obvious to have experimented with the dosage of B. subtilis 747 for this purpose because Rehberger teaches that this strain improves weight gain and feed conversion and because Rehberger’s disclosure is in the context of providing alternatives to antibiotics in commercial broiler operations (col. 1, line 28 through col. 3, line 4). Thus, the teachings of Rehberger are clearly directed to outcomes extending beyond the 14 days tested in Example 10 of Rehberger’s disclosure and it would have therefore been obvious to have observed an improvement over another longer time period such as at least 25 days.
Regarding claims 18 and 23-24, as discussed above Rehberger anticipates or, alternatively, renders obvious the methods of claims 17 and 22 and the recited parameter is considered to be inherent to Rehberger’s disclosure. Thus, the discovery of the specific percentages of change in this parameter (or specific points of time at which these percentages occur) does not render the old process patentably new. MPEP § 2112(I) and (II).
Alternatively, as discussed above, even if Rehberger does not explicitly teach the claimed improvement in ADWG, a person having ordinary skill in the art would have routinely experimented with various amounts of B. subtilis strain 747 to achieve an ADWG of at least 3% or 5% (claims 18 and 23-24). It would have been obvious to have experimented with the dosage of B. subtilis strain 747 for this purpose because Rehberger teaches that this strain improves weight gain and feed conversion.
Regarding claims 19 and 25-26, as discussed above Rehberger anticipates or, alternatively, renders obvious the methods of claim 44 and the recited parameter is considered to be inherent to Rehberger’s disclosure. Thus, the discovery of the specific percentages of change in this parameter (or specific points of time at which these percentages occur) does not render the old process patentably new. MPEP § 2112(I) and (II).
Alternatively, as discussed above, even if Rehberger does not explicitly teach the claimed improvement in ADLWG, a person having ordinary skill in the art would have routinely experimented with various amounts of B. subtilis strain 747 to achieve an ADLWG of at least 1% (claim 25) or 3% (claims 19 and 26). It would have been obvious to have experimented with the dosage of B. subtilis strain 747 for this purpose because Rehberger teaches that this strain improves weight gain and feed conversion.
Regarding claim 32, as discussed above, Rehberger anticipates or, alternatively, renders obvious the method of claim 17. Rehberger teaches that at least one strain can be administered to an avian to improve average daily weight gain and feed conversion (abstract; col. 4, lines 11-14; claim 4). Thus, in addition to ADWG, Rehberger teaches improving the feed conversion (i.e., the feed conversion efficiency and feed conversion ratio).
And although claim 32 recites specific percentages and time points at which the improvement occurs, Rehberger’s silence as to the claimed percentages of changes to FCE and FCR (or when they happen) is not sufficient to overcome Rehberger’s disclosure. The claimed effect on FCE and FCR is a predictable characteristic inherent to the administration of Bacillus subtilis 747 to broiler chickens. Because the claim is to a method of feeding broiler chickens and the Bacillus subtilis strain 747 is merely provided in an amount sufficient provide at least one of the claimed effects, Rehberger’s disclosure is sufficient to anticipate the claim as there is no requirement that a person having ordinary skill in the art would have recognized the inherent disclosure at the time of publication. Rehberger teaches that this strain is capable of affecting weight gain and feed conversion. Thus, the discovery of the specific percentages of change in these parameters (or when these changes occur) does not render the old process patentably new. MPEP § 2112(I) and (II).
Alternatively, even if Rehberger does not explicitly teach the two claimed parameters, a person having ordinary skill in the art would have routinely experimented with various amounts of Bacillus subtilis strain 747 to achieve an FCE of at least 6% and FCR of at least -6%. It would have been obvious to have experimented with the dosage of B. subtilis 747 for this purpose because Rehberger teaches that this strain improves weight gain and feed conversion. A person having ordinary skill in the art could performed this experimentation over an arbitrary time period range such as “at least 25 days”. Additionally, Rehberger’s disclosure is in the context of providing alternatives to antibiotics in commercial broiler operations (col. 1, line 28 through col. 3, line 4). Thus, the teachings of Rehberger are clearly directed to outcomes extending beyond the 14 days tested in Example 10 of Rehberger’s disclosure and it would have therefore been obvious to have observed an improvement over another longer time period such as at least 25 days.
Thus, claim 32 is anticipated by or, alternatively, obvious over Rehberger.
Regarding claim 33, as discussed above, Rehberger anticipates or, alternatively, renders obvious the method of claim 22. Rehberger teaches that at least one strain can be administered to an avian to improve average daily weight gain and feed conversion (abstract; col. 4, lines 11-14; claim 4). Thus, in addition to ADWG, Rehberger teaches improving a second performance variable which comprises improved feed conversion (i.e., the feed conversion efficiency and feed conversion ratio).
Regarding claims 34-36, and 38, as discussed above Rehberger anticipates or, alternatively, renders obvious the methods of claims 32 and 33 and the recited parameters are considered to be inherent to Rehberger’s disclosure. Thus, the discovery of the specific percentages of change in these parameters (or specific points of time at which these percentages occur) does not render the old process patentably new. MPEP § 2112(I) and (II).
Alternatively, as discussed above, even if Rehberger does not explicitly teach the four claimed parameters, a person having ordinary skill in the art would have routinely experimented with various amounts of B. subtilis 747 to achieve FCE of at least 9% or 6% (claims 34 and 36-37) or an FCR of at least -8% or -6% (claims 35 and 38-39). It would have been obvious to have experimented with the dosage of B. subtilis 747 for this purpose because Rehberger teaches that this strain improves weight gain and feed conversion.
Regarding claims 40-41, as discussed above, there is no requirement that Rehberger discloses the improvement of ADWG or ADLWG over “at least 25 days”. Similarly, Rehberger does not need to disclose improvement of ADWG or ADLWG over “at least 35 days” or “at least 42 days” as claimed. The improvement to ADWG and ADLWG is inherent to the method of feeding chickens with B. subtilis strain 747 and therefore, the claimed methods are anticipated.
Additionally, although Rehberger did not even need to disclose that the strain could improve body weight (as this is merely an effect resulting from the administration taught by Rehberger), Rehberger nonetheless teaches that the strain improves body weight and feed conversion. Accordingly, the claims are anticipated regardless of its disclosure of a particular time period over which the effect disclosed by Rehberger occurs.
Alternatively, even if Rehberger does not explicitly teach the claimed parameters over the claimed time period, a person having ordinary skill in the art would have routinely experimented with various amounts of B. subtilis 747 to achieve an improvement of the ADWG or ADLWG over an arbitrary time period range such as “at least 35 days” or “at least 42 days”. Rehberger’s disclosure is in the context of providing alternatives to antibiotics in commercial broiler operations (col. 1, line 28 through col. 3, line 4). Thus, the teachings of Rehberger are clearly directed to outcomes extending beyond the 14 days tested in Example 10 of Rehberger’s disclosure and a person having ordinary skill in the art would therefore be prompted to experiment with administration regimens which resulted in long-term improvements of ADWG or ADLWG.
Claims 46-47 are rejected under 35 U.S.C. 103 as obvious over Rehberger et al. (US 10,201,574 B1).
The teachings of Rehberger are set forth above and applied herein.
Regarding claims 46-47, as discussed above, Rehberger teaches, or alternatively, renders obvious the methods of claims 17 and 22. As discussed above, Rehberger teaches that Bacillus subtilis strain 747 can be administered to broiler chickens (i.e., broiler chickens are fed the feed having the active ingredient comprising Bacillus subtilis strain 747). Rehberger differs from the instant claims because it does not teach that the administration is for at least 25 days.
Nonetheless, a person having ordinary skill in the art could have arrived at this dosing regimen as a result of routine experimentation. Although it is recognized that Rehberger provides a working example (Example 10) wherein administration occurs over 14 days, that does not mean that Rehberger teaches away from or otherwise suggests that the Bacillus subtilis strain 747 should not be administered for longer than 14 days. Rehberger’s working example was terminated at 14 days in order to assess gastrointestinal changes (col. 38, lines 31-344). Accordingly, a person having ordinary skill in the art would have understood Rehberger’s disclosure to suggest that the probiotic strain could be administered over a longer time frame than 14 days because Rehberger’s disclosure is directed to improving body weight for commercial operations and there is no teaching or suggestion in Rehberger that the composition should only be administered for 14 days.
A person having ordinary skill in the art would have been motivated to routinely experiment with various administration lengths in order to, for example, provide long term benefits to broiler chickens and could have arrived at the range of “at least 25 days” with a reasonable expectation of success. There is no evidence of record that administration for “at least 25 days” provides an unexpected or remarkable effect (such as an unexpected or remarkable change in ADWG).
For at least these reasons, claims 46-47 are obvious over Rehberger as a result of routine experimentation.
Conclusion
No claim is allowed.
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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/GRANT C CURRENS/Examiner, Art Unit 1651
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