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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 6/7/26. Claims 1-18 are pending and considered on the merits.
Claim Interpretation
Claims 1, 8, 9, 10 and 11 include intended results from the active steps executed by the method. These include the pathogens inhibited, the reduction in the days the ruminant has diarrhea, and the weight gain of the ruminant. MPEP 2111.04 state:
a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’"
Therefore these limitations are not afforded significant patentable weight and art reading on the method steps of the claim will also read on the intended results since the same steps should obviously yield the same results. However if these results are an unexpected improvement, then this should be pointed out by the Applicant and the claims made commensurate in scope with the results shown. Applicant is encouraged to contact the Examiner if any questions about this arise.
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) 1, 2, 4, 5, 8-12, 14, 15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garner et al. (US 2011/0189132, in IDS 11/11/24).
Garner et al. teach feeding ruminant fermentors (i.e. ruminants) a probiotic composition to inhibit or reduce pathogenic bacteria in their gastrointestinal tract [0031-0033, 0069, 0082]. They teach the probiotic composition can include the following species:
Bacillus licheniformis [0085];
Bacillus subtilis [0085];
Lactobacillus animalis, including strain LA51 [0085];
Propionibacterium freudenreichii including strain PF24 [0085];
This composition contains concentrations of probiotics from 1 x 108-109 cfu/day [0036-0037] per ruminant animal (e.g. per head). They teach these probiotic strains can be formulated into an animal feed [038, 0122]. This animal feed can comprise additional components including amino acids, the vitamin L-ascorbic acid, minerals including montmorillonite, and polysaccharides [0106].
The Applicant’s Specification discloses strain LA51 is L. animalis DSM 33570 and strain PF24 is P. freudenreichii DSM34127 (pg. 10, lines 1-5). It is used to inhibit gastrointestinal growth of both Clostridium perfringens, E. coli, and Salmonella [0131] and to reduce the incidence and severity of diarrhea [0128]. They teach the growth of Salmonella and E. coli is assayed to determine the amount of pathogenic inhibition (Example 2) from the probiotic composition. They also teach that probiotics in animal feeds for ruminants are a well-established means of improving average daily weight gain [0011] by optimizing the production of volatile fatty acids [0128-00130]. While they do not expressly teach assessing the weight gain after administration of the composition, this would be obvious since weighing (e.g. assessing) the animal is a fundamental method to determine improved average daily weight gain. This would make it obvious to one of ordinary skill to use this composition for inhibit the pathogens in the gastrointestinal tract of an animal and/or improve weight gain of an animal.
While Garner et al. does not expressly teach all the claim limitations in a single embodiment, it would be obvious for one of ordinary skill in the art to perform the claimed method after reviewing the entire disclosure. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 3 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garner et al. (US 2011/0189132) as applied to claims 1, 2, 4, 5, 8-12, 14, 15, and 18 above, and further in view of Afeyan et al. (US 2016/0158295).
Garner et al. renders obvious administering a probiotic composition comprising Bacillus licheniformis, Bacillus subtilis, Lactobacillus animalis strain LA51 and
Propionibacterium freudenreichii strain PF24 as an animal feed to both inhibit gastrointestinal pathogenic infection and improve average daily weight gain in ruminates. However they do not teach the specific ratio of these probiotics listed in claims 3 and 13. However this would be obvious in view of Afeyan et al. who teach administering probiotic compositions to cows (Afeyan, [0181]). And that the probiotics can be at a ratio ranging from 1:1 to 1:3 (Afeyan, [0064]). The various bacteria can be combined at different ratios (Afeyan, [0173]). Therefore the ratio of 1:1:1:3 of the various claimed species can be met by routine optimization by one of ordinary skill in the art by simply adjusting the ratios of each bacteria listed by Garner et al. within the ranges disclosed by Afeyan et al. to produce an optimum probiotic composition to reduce pathogenic infection and increase average daily weight gain in ruminants (MPEP 2144.04 II).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 6, 7, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garner et al. (US 2011/0189132) as applied to claims 1, 2, 4, 5, 8-12, 14, 15, and 18 above, and further in view of Sandvang et al. (US 11291695).
Garner et al. renders obvious administering a probiotic composition comprising Bacillus licheniformis, Bacillus subtilis, Lactobacillus animalis strain LA51 and
Propionibacterium freudenreichii strain PF24 as an animal feed to both inhibit a gastrointestinal pathogenic infection and improve average daily weight gain in ruminates. However they do not teach the specific strains of Bacillus subtilis DSM32324 and Bacillus licheniformis DSM17236. However this would be obvious in view of Sandvang et al. who administering B. subtilis DSM32324 and B. licheniformis DSM17236 to as probiotics to inhibit E. coli and Clostridium (Sandvang, see Table 1 and 2) and improve average weight gain (Sandvang, col 3, lines 5-15) for ruminants (Sandvang, col 15, lines 1-5). These probiotics are mixed with animal feed (Sandvag, see Table 4). Therefore it would be obvious to substitute these strains into the composition of Garner et al. since Sandvang et al. teach these are suitable probiotics for the same purpose.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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