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 Amendment filed Dec. 3, 2025 has been entered. Claims 1, 4-6, and 9-19 are pending. Claim 1 has been amended. Claim 2 has been canceled.
Claim Rejections - 35 USC § 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 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.
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, 4-6 and 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ross et al. (US Patent No. 6,833, 150 B1; Dec. 21, 2004) in view of Bisgaard-Frantzen et al. (WO 2017/081201; May 18, 2017; using US Equivalent US 2018/0325118 A1).
Regarding claims 1 and 4-5, Ross discloses a process for obtaining a biomass comprising cultivating a bacteriocin-producing lactic acid bacterial strain in a growth medium to obtain a biomass in a culture medium, wherein the bacterial strain is L. lactis, adjusting the pH of the culture medium comprising the bacterial strain and growth medium to 6.3 to 6.7, and, after a holding time at the pH, separating the biomass from the culture medium (col 1 lines 50 – col 2 line 65).
While Ross teaches the step of adjusting the pH, Ross fails to specifically teach that it is adjust to below 5 and further that it is adjusted after the cultivating step.
Bisgaard teaches a method of cultivating a bacteria strain to obtain a biomass, wherein the culture medium containing the biomass is adjusted to a pH below 5 after a cultivating step ([0025] and [0035]). Bisgaard teaches that by lowering the pH to below 5, a biomass is obtained that has unexpectedly higher antifungal activity ([0010]). Bisgaard further teaches that the step of adjusting the pH to below 5 is carried out for a period of 0.1 to 24 hours (claim 61), thus overlapping the claimed hold time of at least 1 hour. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
It would have been obvious to one of ordinary skill in the art to adjust the pH of Ross to a pH below 5 for a hold time of at least one hour as taught by Bisgaard. Doing so would produce a biomass in Ross having a higher antifungal activity as taught by Bisgaard.
As stated above, Ross teaches a step of adjusting pH. Waiting to adjust the pH until after cultivation in Ross is merely a change in order of processing steps and obvious to one of ordinary skill in the art especially as Bisgaard teaches adjusting pH after cultivation and further teaches advantages associated with such step.
Regarding claim 6, Ross teaches that the separation step comprises centrifugation (col 4 lines 50-60).
Regarding claim 9, Ross further teaches adding a flocculant to the culture medium after step b (col 5 lines 1-20).
Regarding claim 10, Ross also further teaches adding an excipient to the biomass after step c (col 5 lines 1-20).
Regarding claims 11 and 17, Ross also teaches adjusting the pH of the biomass to a pH of 6.5 (col 5 lines 1-20), thus falling within the claimed range of 5.5 to 8.0.
Regarding claims 12-13 and 18-19, Ross teaches further making the biomass into a powder col 2 lines 15-35). Ross teaches that the powdered biomass can be spray-dried (col 2 lines 15-35).
Regarding claim 14, Ross in view of Bisaard teaches a composition obtained by the process of claim 1, comprising the biomass comprising the bacteriocin producing strain and a bacteriocin (col 1 lines 50 – col 2 line 65).
Regarding claim 15, Ross further teaches a method for treating a food product by contacting the food product with the biomass (col 3 lines 1-15).
Regarding claim 16, Seme teaches that the food product is a meat product (col 3 lines 1-15).
Response to Arguments
Applicant’s amendment has overcome the 112(d) rejection from the previous Office Action and therefore it has been withdrawn.
Applicant’s arguments with respect to the 103 rejection have been fully considered but were not found persuasive.
Applicant argues on pages 4-6 that one of ordinary skill would not apply the teachings of lowering the pH from Bisgaard to the strains of Ross with any expectation of success because the cited art uses bacteria with different mechanisms of antimicrobial activity.
This is not found persuasive. While the examiner agrees that the prior art teaches different bacterial strains, Bisgaard teaches that the bacterial strains used in the process should be able to produce antifungal metabolites in commercially relevant amounts ([0020]). Bisgaard further teaches that biomass obtained from a process involving acid treatment has unexpected higher antifungal activity than a comparative biomass obtained without acid treatment ([0010]). Bisgaard further refers to “bacteria” in general, reciting Bacillus” as an example “e.g. Bacillus” ([0010]-[0015]). Therefore, the bacteria strain used in the examples in Bisgaard is merely an exemplary embodiment and does not teach away from the generic bacteria teaching in Bisgaard, that the bacterial strains used in the process should be able to produce antifungal metabolites in commercially relevant amounts ([0020]).
As the bacteria strain of Ross is able to produce antifungal metabolites, it is expected that using acid treatment would increase the antifungal activity as taught by Bisgaard.
Further, as stated in MPEP 2123: The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Therefore, the generic teaching that the bacterial strains used in the process of Bisgaard should be able to produce antifungal metabolites ([0020]) renders obvious using an acid treatment in the process of Ross in order to increase antifungal activity.
Applicant further argues that Ross teaches away from lowering the pH by stating that the Lacticin activity increased dramatically when the pH of the growth media was held constate at pH 6.5.
This is not found persuasive as this does not teach away from lowering the pH as Ross does not teach any negative effect of lowering the pH. Further, the claims do not require any amount of bactericidal or fungicidal activity. It would be expected that the combination of the prior art would still result in a desired bactericidal or fungicidal activity.
For the reasons stated above, a 103 rejection is maintained.
Conclusion
No claims are allowed.
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.
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/STEPHANIE A KOHLER/Primary Examiner, Art Unit 1791