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 .
Applicant’s amendment, reply and affidavit filed October 21, 2025 have been received and entered into the case. Claims 1 – 2, 4 – 8 and 24 are pending and have been considered on the merits. All arguments and the declaration have been fully considered.
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.
Claims 1 – 2, 4 – 8 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Ware et al. (8496925) and Brashears (US 2004/0043012); OR Brashears et al. (US 7323166, concurrently cited by US 2004/0043012).
Regarding claims 1 and 24, Ware teaches methods for reducing pathogens (or inhibiting growth of nosocomial pathogens or spoilage microorganisms) in animal feed and meat products (food that could be fed to dogs or cats) (abstract), comprising contacting the animal feed and/or meat product (dog or cat food) with a combination of lactic acid bacteria (abstract) such as Lactobacillus acidophilus and Lactobacillus salivarius (col.2 line 50 – col.3 line 8; col. 5 – 6) and incubating the bacteria and meat products for 0 – 14 days, wherein pathogen populations were significantly lower at day 4 (example 2). In this regard, one of ordinary skill in the art would recognize that significant reduction of population includes growth inhibition prior to, which would have occurred in the hours prior to day 4, or in hours 0 – 96, which encompasses hours 4 – 72.
Ware does not teach the methods wherein the LAB are the claimed strains. However, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to substitute other LAB strains, specifically L. salivarius and/or L. acidophilus in the methods of Ware since the species were well known in the art to demonstrate inhibitory activity against pathogens. Ware teaches LAB strains effective against E. coli O157:H7 to include 6 strains of L. acidophilus (col.3 line 1-5, col.5-6) and L. salivarius (col.5); and Brashears teaches at least 11 strains of L. salivarius and L. acidophilus that are effective against E. coli O157:H7 (example 2, Tables 2, 3). Further, Ware and Brashears teach the LAB species are effective against the same E. coli and Salmonella pathogens (Brashears 0058; Ware, col.6) in addition to adding them to animal feed (Ware abstract, examples 2, 10; Brashears, examples 2, 3, 13). Moreover, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to substitute various strains of L. salivarius and/or L. acidophilus in the methods of Ware with a reasonable and predictable expectation for successfully inhibiting pathogen growth in animal feed and/or meat products.
Regarding claims 2 and 4, Ware teaches the method wherein bacterial strains are added to fresh ground meat (wet food) (examples); while Brashears teaches the bacteria are mixed with animal feed (0053, figures, examples, 0035, 0039) that is dry (kibble) moist or wet (figure 2, 0053, 0055).
Regarding claims 5 – 8, Ware teaches the bacteria are effective against Staphylococcus aureus, Salmonella, E. coli (examples, claims); while Brashears teaches the bacteria are effective against Listeria monocytogenes, E. coli, Salmonella, E. coli O157:H7, Campylobacter jejuni, and Vibrio (0058, example 2).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Previous rejections under 35 U.S.C. 103 as being unpatentable over Castillo et al (2016, IDS filed 01.18.2019, NPL #1) and Khodammohammadi (2013) are withdrawn due to applicant’s argument and statement that that Castillo is applicant’s work, published less than one year prior to the filing date of the instant application, which is found at paragraphs 3 – 6 of the declaration filed 10.21.2025.
Response to Arguments
Applicant argues the cite art fails to teach the combination of L. bacillus L14 (PTA-127732), L. salivarius L28 (PTA-127731) and L. salivarius FS56 (PTA-127730); and that various strains of L. salivarius and L. acidophilus are not equivalent or substitutable, providing a declaration of support.
Specifically, at paragraph 11 of the declaration, applicant provides a reference stating antimicrobial activity of L. acidophilus and other LAB are strain specific and not species or genus specific (Dinev), and thus there is no way to know which strains would inhibit specific strains of bacteria and are therefore not substitutable.
However, this argument fails to persuade. The quote relied upon is not directed to whether L. acidophilus strains are commonly active against E. coli or Salmonella, but rather a list of 48 species and genera of bacteria listed in Tables 1 and 2. In this regard, the document fails to establish that antimicrobial activity against E. coli and/or Salmonella is variable in different strains of L. acidophilus. Rather, the document lists numerous references for which one can review to determine activity against the 48 species and genera. Moreover, the document does not disclose or support any objective evidence that antimicrobial activity of L. acidophilus against at least E. coli and Salmonella is variable between strains. Turning to the reference relied upon for the statement relied upon by applicant, it reveals a single abstract that has not been made of record for proper consideration of evidence.
At paragraphs 12 – 15 of the declaration, applicant cites Ayala arguing that antimicrobial activity of different lactic acid bacteria is variable and the claimed L. salivarius and L. acidophilus strains have activity against all tested pathogens and as such, strains within a species are not substitutable.
However, the arguments fail to persuade because the various LAB “strains” disclosed by Ayala are not strains of the same species claimed but rather include strains across 3 genera. Further, Table 5 indicates only one single strain of L. salivarius and no L. acidophilus. In this regard, the reference does not show evidence of variability within the claimed species as argued. Moreover, this failure combined with the cited prior art disclosures of 17 L. acidophilus and L. salivarius strains each having the same activity against the same microbes is not persuasive.
Finally, at paragraphs 16 – 22, applicant argues Chaves shows different strains of L. salivarius are not substitutable since strains colonize different sections of the intestinal tract depending on age of the subject, there is variability between strains against Salmonella infection, oral pathogens and antibiotic resistance, and the FDA requires separate approval for differing strains.
However, while it is appreciated that various strains of L. salivarius are variable across a variety of parameters, the reference fails to show that there is variability as it pertains to activity against the claimed pathogens. Thus, the attributes disclosed therein are not commensurate in scope with the claimed invention or those demonstrated by the cited prior art. Moreover, this failure combined with the cited prior art disclosures of 17 L. acidophilus and L. salivarius strains each having the same activity against the same microbes is not persuasive.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
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 RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699