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 .
The Office Action is in response to the filing on March 09, 2026. Claims 1, 12, 19, has been amended. Claims 11, 18, and 32 has been cancelled. Claims 1-10, 12-17, and 19-31 are currently pending and under examination.
Withdrawal of Rejections:
Applicant’s arguments, page 7 of 18, Rejection Under 35 U.S.C 112(a), filed regarding claims 1-32, with respect to enablement requirements have been fully considered and are persuasive. The 35 U.S.C. 112(a) rejection of claims 1-32 has been withdrawn. Applicant has provided compliance with the requirements.
Response to Arguments:
Applicant's arguments regarding claims 1,2,8, and 9 under 35 U.S.C. 102(a)(1) have been fully considered but they are not persuasive. The applicant argues that the strains of ARM & HAMMER™ et al., Bacillus subtilis 839 and Bacillus subtilis 4976 are not the same strains as the claimed strains However, applicant. has not provided any evidence that the prior art 839 and 4976 are not the same . Furthermore, assuming arguendo that the strains are different, the claims recite “active variants thereof” and the strains of ARM & HAMMER™ et al., Bacillus subtilis 839 and Bacillus subtilis 4976 reads on the active variant claim language.
Applicant argues that the strains from ARM & HAMMER™ et al., are not available and therefore the disclosure is not enabling. However, the reference states that the strains are available to the public through ARM & HAMMER™ et al., which control organisms that cause mastitis, therefore Bacillus subtilis 839 and Bacillus subtilis 4976 are publicly available.
Applicant’s presents the same arguments against ARM & HAMMER™ et al. when discussing 35 U.S.C. 103 rejections of claims 3, 4, 5, 6, 7, 10, 12, 16, 19-20, 23-25, 27-30, and 31. These arguments have been fully considered but are not persuasive, for the same reasons as discussed above.
Applicant has not provided any evidence in light of the same parent company and/or assignee (Church & Dwight Co. Inc.) for strains disclosed by ARM & HAMMER™ et al., Bacillus subtilis 839 and Bacillus subtilis 4976 and the instant application.
Claim Rejections - 35 USC § 102
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claim(s) 1, 2, 8, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoard’s DairyMan “ARM & HAMMER™ Adds New Bacillus Strains to Targeted Microbial Solutions” (11/25/2019), hereafter “ARM & HAMMER™”.
Regarding claim 1, ARM & HAMMER™ Animal and Food Production discloses two beneficial Bacillus strains, Bacillus subtilis 839 and Bacillus subtilis 4976; page 1, paragraph 1 ARM & HAMMER™ states that the Bacillus strains 839 and/or 4976 are effective for reducing growth of, “E. coli, Salmonella, Clostridium perfringens, and other clostridial bacteria that are common in poultry swine, and beef and dairy cattle”, wherein these organisms are causes of mastitis.
Regarding claim 2, the reference teaches the instantly claimed composition comprising Bacillus subtilis strains 839 and/or 4976 for the purpose of reducing or preventing notable pathogens, wherein these organisms are causes of mastitis: E. coli, Salmonella, Clostridium perfringens, and other clostridial bacteria that are common in poultry swine, and beef and dairy cattle”; (page 1, paragraph 1). Therefore, since the reference teaches pathogenic organisms that are causative agents of mastitis-- in the instant case, the recitation of said mastitis causing organism is not given patentable weight.
Regarding claim 8 and 9 the prior art teaches the instantly claimed composition comprising Bacillus subtilis 839 and Bacillus subtilis 4976. Therefore, since the prior art teaches the same composition, the prior art will be capable of performing the intended use. See MPEP 2111.02 II. In instant case, the recitation to be applied is future intended use which is not given patentable weight. Regarding claim 9, since the effective amount is applied as part of the intended use, the recitation is not given patentable weight.
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.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over ARM & HAMMER™ in view of Bellot et al. (US8025874B2).
The teachings of ARM & HAMMER™ have been disclosed above.
The reference teaches with regards to claim 3, that said Bacillus subtilis 839 and said Bacillus subtilis 4976 are being used in combination to provide the desired effect of “[fighting] food-borne pathogens as well as disease-causing pathogens that hamper animal efficiency and performance”; page 1, paragraph 6.
ARM & HAMMER™ does not expressly disclose the concentration of Bacillus subtilis 839 and Bacillus subtilis 4976 or active variant thereof in equal proportions.
Bellot et al., teaches the application of Bacillus subtilis strains in animal bedding to control odors from animal waste, “In at least one embodiment of the composition, substantially equal amounts (based on colony forming units (cfu)) of each strain are used.” (Lines 27-32, Column 4).
Therefore, it would be obvious to one of ordinary skill in the art, at the time of the effective filing date of the invention, to provide equal proportions of Bacillus subtilis 839 and Bacillus subtilis 4976. The motivation for combining the teachings of the prior art are for minimizing competition between said organisms during growth cycles and/or to enhance health benefits with said amounts of the treatment, including in bedding.
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over ARM & HAMMER™ in view of Nanjing Tech University (CN107446857B; referred to as ‘6857B).
The teachings of ARM & HAMMER™ have been discussed above.
The reference does not disclose claim 4 wherein at least one of said Bacillus strains is a powdered, lyophilized strain, and/or used for bedding for a dairy animal.
However, ‘6857B teaches powdered, lyophilization of Bacillus strains (Abstract).
It would be obvious to one of ordinary skill in the art, at the time of the effective filing date, to have modified ARM & HAMMER™ to use lyophilization followed by powdered administration of said Bacillus strains, as suggested by ‘6857B.
The motivation for performing the modification would have been to increase “rejuvenation survival rate of Bacillus subtilis freeze-dried powder…freeze-dried powder has stable properties, is convenient for long-term storage and long-distance transportation” as taught by ‘6857B.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over ARM & HAMMER™ in view of Barach et. al., (US4720460A).
The teachings of ARM & HAMMER™ have been discussed above.
The reference does not teach a cryoprotectant.
The reference does not teach a preservative.
Regarding claims 5-6, Barach et al., teaches freeze-drying (lyophilization) for acid producing bacteria (lactobacilli) increases viability of microorganisms during storage along with other cryoprotectant materials and preservative(s) (Section 1, paragraphs 5-8; Section 2, paragraphs 1 and 2).
Therefore, it would be obvious to one of ordinary skill in the art, at the time of the effective filing date, to modify ARM & HAMMER™ by providing a powdered, lyophilized composition of Bacillus strains with cryoprotectant and preservatives as suggested by Barach et. al.
The motivation for performing the modification is to improve viability, storage, and preserve the organisms and their traits.
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over ARM & HAMMER™ in view of Envera Lic LLC, (AU 2019275569 B2).
The teachings of ARM & HAMMER™ have been discussed above.
Regarding claim 7, the reference does not disclose, said Bacillus strain(s) concentrations within a range of 7.5 x 105 CFU/gram - 1 x 106 CFU/gram (or per ml) or application to bedding.
Envera Lic LLC teaches, “applying a composition comprising a bacterial spore and a germinative compound as described herein to animal waste, bedding, or litter” wherein, the amounts applied are at least about 1x103, 1x104 1x105, 1x106, 1x107, 1x108 or 1x109 CFU per gram or per ml (page 37, lines 1-6; page 37 lines 11-13).
Therefore, it would be obvious to one of ordinary skill in the art, at the time of the effective filing date, to further modify ARM & HAMMER™ in view of Envera Lic LLC, to provide concentrations of 7.5 x 105 CFU/gram to about 1 x 106 CFU/gram or per ml (page 12, lines 24-26; page 37, paragraphs 1-3 and lines 29-31; page 38, lines 1-2; page 34, line 21-30, and claim 15).
The motivation for performing the modification is to provide a result effective concentrations of each organism, as tested, that reduces or prevents “E. coli, Salmonella, Clostridium perfringens, and other clostridial bacteria” (ARM & HAMMER™; page 1, paragraph 2). In the instant claim, the effective amount is applied as part of the intended use, the recitation is not given patentable weight.
Regarding claim 10, the reference does not disclose formulations for different carriers and/or applications for said Bacillus composition.
However, Envera Lic LLC teaches an “acceptable carrier may be a liquid carrier, solid carrier, a water-soluble carrier, or any other suitable carrier.” for Bacillus subtilis strains (Envera Lic LLC; page 33, lines 30-31).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to combine ARM & HAMMER™ with Envera Lic LLC, and to apply the Bacillus species composition with a formulation for a carrier.
The motivation for performing the modification is to provide the composition of the instant claim, using a compatible format (i.e. carrier) for a given medium (i.e. bedding) to then reduce pathogens associated with mastitis, in bedding.
Claims 12, 13, 16, 19-20, 23-25, 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over ARM & HAMMER™ in view of Envera Lic LLC (AU2019275569B2), and further in view of Al-Qumber et al., “Commensal bacilli inhibitory to mastitis pathogens isolated from the udder microbiota of healthy cows” Journal of Applied Microbiology, February 2006.
The teachings of ARM & HAMMER™ have been discussed above.
Regarding claims 12,16, 19, 27-30 ARM & HAMMER™ does not expressly disclose application of the instant composition to bedding for dairy animals to then reduce mastitis-associated indices of disease.
ARM & HAMMER™ in view of Envera Lic LLC teaches topical application of Bacillus subtilis spores/ forespores, to animal waste and bedding as a method of treatment or prevention of pathogenic microorganisms (page 12, lines 24-26; page 37, paragraph 1-3 and lines 29-31; page 38, lines 1-2; page 34, line 21-30, and claim 15).
Further, Al-Qumber et al., teaches the efficacy of Bacillus species isolates from the udder flora of healthy cattle, to inhibit mastitis-causing pathogens along with indices of mastitis (i.e. somatic cell counts; SCC and sub-clinical mastitis) (Abstract, page 1152; paragraph 2, page 1152; Materials and Methods ‘Cows sampled’, page 1153, paragraph 3).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to have modified ARM & HAMMER™ with methods described by Envera Lic LCC, as suggested by Al-Qumber et. al., to apply the instant composition to bedding, to reduce exposure to mastitis associated pathogens in dairy animals, resulting in reduced indices of disease.
The motivation for performing the modification is to apply the composition of ARM & HAMMER™ to bedding, to then prevent or reduce said pathogens important to mastitis and to indicate changes to cattle performance, illustrated by established indices of mastitis.
Regarding claim 27, clinical and subclinical mastitis are manifestations of ‘mastitis’, the recitation of the disease stages is not given patentable weight.
Regarding claims 13 and 20, the reference does not disclose, said Bacillus strain(s) concentrations within a range of 7.5 x 105 CFU/gram - 1 x 106 CFU/gram (or per ml) or application to bedding.
However, Envera Lic LLC teaches, “applying a composition comprising a bacterial spore and a germinative compound as described herein to animal waste, bedding, or litter” wherein, the amounts applied are at least about 1x103, 1x104 1x105, 1x106, 1x107, 1x108 or 1x109 CFU per gram or per ml (page 37, lines 1-6; page 37 lines 11-13).
Therefore, it would be obvious to one of ordinary skill in the art, at the time of the effective filing date, to further modify ARM & HAMMER™ to provide concentrations of 7.5 x 105 CFU/gram to about 1 x 106 CFU/gram or per ml (Envera Lic LLC, page 12, lines 24-26; page 37, paragraphs 1-3 and lines 29-31; page 38, lines 1-2; page 34, line 21-30, and Envera claim 15).
The motivation for performing the modification is to provide concentrations of each organism, as tested, within a result effective dose that reduces or prevents “E. coli, Salmonella, Clostridium perfringens, and other clostridial bacteria” (ARM & HAMMER™; page 1, paragraph 2). In the instant claim, the effective amount is applied as part of the intended use, the recitation is not given patentable weight.
Regarding claim 23, the reference does not disclose formulations for different carriers and/or applications for said Bacillus composition.
However, Envera Lic LLC teaches an “acceptable carrier may be a liquid carrier, solid carrier, a water-soluble carrier, or any other suitable carrier.” for Bacillus subtilis strains (Envera Lic LLC; page 33, lines 30-31).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to further modify ARM & HAMMER™ to apply the Bacillus species composition with a formulation for a carrier.
The motivation for performing the modification is to provide the composition of the instant claim, using a compatible format (i.e. carrier) for a given medium (i.e. bedding) to then reduce pathogens associated with mastitis, in bedding.
Regarding, claim 24 the reference does not teach, spraying said Bacillus strain composition in liquid formulation onto said bedding.
However, Envera Lic LLC describes the composition of Bacillus strain(s), wherein contacting comprises spraying composition in liquid formulation. Envera Lic LLC further discloses, “The compositions may also be administered to the animal by adding the composition to drinking water for the animal, spraying the composition onto the animals, or application via paste, gel or bolus” (paragraph 3, page 35). Envera Lic LLC further discloses, “The bacterial spores may be mixed with any suitable carrier and sprayed or spread over the soil, growing medium, or compost” (paragraph 5, page 35).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to have further modified ARM & HAMMER™ to spray the instant composition onto bedding.
The motivation for making the modification would be to provide a dispersion method for adding said Bacillus strains onto bedding, to then reduce unwanted microorganisms which indicate or contribute to mastitis.
Regarding claim 25, the reference does not teach the composition applied in dry formulation to said bedding.
However, Envera Lic LLC provides, “Dry carriers include, but are not limited to, animal feed, whey, limestone (calcium carbonate), rice hulls, yeast culture, dried starch, and sodium silico aluminate.” (Lines 3-9, page 34). Methods of application include, “The resultant spray dried powder containing the intimate mixture of Bacillus spores. … The spray dried Bacillus spores without the addition of L-alanine are described as "GO” “(Lines 23-32, page 59). Envera Lic LLC further describes, “A method of treating animal waste, bedding or litter comprising applying a composition comprising a dried intimate mixture of a bacterial spore…” (Claim 15).
Therefore, it would be obvious to one with ordinary skill in the art at the effective date of filing to use the dry formulation and application, to animal bedding, animal feed, or animal waste, as described by Envera Lic LLC.
The motivation for making the modification would be an effective method to disperse said Bacillus strains to dairy cattle bedding.
Claims 14 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over ARM & HAMMER™ in view of Envera Lic LLC (AU2019275569B2), and Al-Qumber et al., “Commensal bacilli inhibitory to mastitis pathogens isolated from the udder microbiota of healthy cows” Journal of Applied Microbiology, February 2006, as applied to claims 12 and 19 above, and further in view of Bellot et al. (US8025874B2).
The teachings of ARM & HAMMER™ in view of Envera Lic LLC (AU2019275569B2), and Al-Qumber et al. have been discussed above.
Regarding claims 14 and 21, ARM & HAMMER™ in view of Envera Lic LLC (AU2019275569B2), and Al-Qumber et al. does not expressly disclose the concentration of Bacillus subtilis 839 and Bacillus subtilis 4976 or active variant thereof in equal proportions.
Bellot et al., teaches the application of Bacillus subtilis strains in animal bedding to control odors from animal waste, “In at least one embodiment of the composition, substantially equal amounts (based on colony forming units (cfu)) of each strain are used.” (Lines 27-32, Column 4).
Therefore, it would be obvious to one of ordinary skill in the art, at the time of the effective filing date of the invention, to provide equal proportions of Bacillus subtilis 839 and Bacillus subtilis 4976.
The motivation for making the modification is for minimizing competition between said organisms during growth cycles and/or to enhance health benefits with said amounts of the treatment, including in bedding.
Claims 15 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over ARM & HAMMER™ in view of Envera Lic LLC (AU2019275569B2) and Al-Qumber et al., applied to claims 12 and 19 above, and further in view of Nanjing Tech University (CN107446857B; referred to as ‘6857B).
The teachings of ARM & HAMMER™ in view of Envera Lic LLC (AU2019275569B2) and Al-Qumber et al., have been discussed above.
The reference does not disclose wherein at least one of said Bacillus strains is a powdered, lyophilized strain, and/or used for bedding for a dairy animal.
However, ‘6857B teaches powdered, lyophilization of Bacillus strains (Abstract).
It would be obvious to one of ordinary skill in the art, at the time of the effective filing date, to have further modified ARM & HAMMER™ to use lyophilization followed by powdered administration of said Bacillus strains, as suggested by ‘6857B.
The motivation for performing the modification would have been to increase “rejuvenation survival rate of Bacillus subtilis freeze-dried powder…freeze-dried powder has stable properties, is convenient for long-term storage and long-distance transportation” as taught by ‘6857B.
Claims 17 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over ARM & HAMMER™ in view of Envera Lic LLC (AU2019275569B2), and Al-Qumber et al., as applied to claims 12 and 19 above, and further in view of Singh et. al., “A Review: Effect of Bedding Material on Production, Reproduction and Health and Behavior of Dairy Animals” International Journal of Livestock Research, Vol. 10 (7); July 2020.
The teachings of ARM & HAMMER™ as modified have been discussed above.
Regarding claims 17 and 26, ARM & HAMMER™ in view of Envera Lic LLC., does not disclose select types of bedding.
However, Singh et al, describes, conventional bedding practices and those bedding groups as described in claims 17 and 26 for dairy cattle “bedding materials for the animals like sand, wood shavings, rubberized mats, concrete floor, saw dust, straws” (Abstract; pages 13-14) and “RMS” (page 16).
Therefore, it would be obvious to one of ordinary skill in the art, at the time of the effective filing date, so as to further modify ARM & HAMMER™, as suggested by Singh et. al., to apply the method to different types of bedding.
The motivation to utilize the instantly claimed bedding: as Singh et al., teach the state of the art of animal bedding in which it is known to utilize the instantly claimed material to make animal bedding. Thus, applying a known composition for its antimicrobial properties to known animal bedding to prevent infection and/or mastitis in animals would have been prima facie obvious in light of the prior art.
Therefore, making the additional modification to ARM & HAMMER™, would be beneficial to dairy cattle health as stated, “It has been investigated that housing system and resting surface have influence on milk yield and reproductive performance similar to feeding and keeping methods in dairy herd”, (Page 12, Introduction, paragraph 1; Singh et al) .
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over ARM & HAMMER™ ™ in view of Envera Lic LLC (AU2019275569B2), and Al-Qumber et al., as applied above in the rejection of claim 19, and further in view of Choonkham et al, “Effects of on-farm supplemental feeding of probiotic Bacillus subtilis on milk production in lactating dairy cows under tropical conditions” Journal of Animal and Feed Sciences, Vol 29; September 2020, pages 199–205.
The teachings of ARM & HAMMER™ as modified have been discussed above.
Regarding claim 31, the reference does not teach measurements of dairy cattle performance with respect to somatic cell counts, milk production, or quality of milk products.
However, Choonkham et al teaches “Milk yield increased linearly (P < 0.01) as B. subtilis supplementation increased... produced 1.7 kg/day more milk than animals from CON (“control”) group” (Results, page 202, paragraph 2).
It would be obvious for one of ordinary skill in the art, at the effective date of filing to treat bedding with the instant composition to inhibit or reduce pathogens, taught by “ARM & HAMMER”, and in view of Envera Lic LLC this would then result in increased performance (i.e. milk yield and quality) as indicated by Choonkham et al., and therefore, decrease symptoms/signs associated with mastitis, as indicated by Al-Qumber et al.
The motivation for making the modification would be to demonstrate measurements of dairy cattle performance following exposure to bedding containing the instant composition which would further illustrate reductions in indices linked to mastitis.
Conclusion
No claims are allowable.
THIS ACTION IS MADE FINAL. 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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights