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
Status of Claims
Note: The amendment of June 29th 2026 has been considered.
Claims 2-4, 6-15, 17-32 have been cancelled.
Claim 37 was added.
Claims 1, 5, 16 and 33-37 are pending in the current application.
Claims 33-36 are withdrawn from consideration.
Claims 1, 5, 16 and 37 are examined in the current application.
Any rejections not recited below have been withdrawn.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35 of the U.S. Code not included in this action can be found in a prior Office action.
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, 5, 16 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over NPL Contreras-Govea et al., “Microbial inoculants for Silage” (from Focus on Forage – Vol 8: No. 4) in view of Holzer et al., “The role of Lactobacillus buchneri in forage preservation” (from TRENDS in Biotechnology Vol. 21 No. 6. Pp. 282-287). As evidenced by NPL Jones at al., “Nisin and the Market for Commercial Bacteriocins” (from Http://ageconsearch.umn.edu/bitstream/90779/2/).
Regarding claim 1: Contreras-Govea discloses fermenting silage with at least one obligatory heterofermentative lactic acid bacteria (i.e., lactobacillus buchneri) and at least one homofermentative bacterial strain (e.g., an enterococcus species) in order to provide silage with better dry matter recovery and aerobic stability (see Contreras-Govea page 1 left column to page 2 top left column). A fact that is also observed in Holzer (see Holzer page 285 right column to page 286 right column). Contreras-Govea fails to disclose selecting a homofermentative bacterial strain which does not reduce the growth of the heterofermentative lactic acid bacteria and does not produce an excess amount of lactic acid; However, Contreras-Govea discloses that the lactic acid formed by the homofermentative lactic acid bacteria quickly lowers the pH which inhibits other bacteria (see Contreras-Govea page 1, right column). Contreras-Govea also discloses that the speed and efficiency of the fermentation (i.e., pH drop rate) depends on the number and type of bacteria, and that the speed of pH drop affects the quantity of lactic acid produced by the bacteria (see Contreras-Govea page 1, left column). Holzer, discloses that aerobic deterioration is directly related to excess lactic acid and aerobic stability is directly related to acetic acid content, where homofermentative lactic acid bacteria are known to form lactic acid and heterofermentative lactic acid bacteria (e.g., lactobacillus buchneri) are known to convert lactic acid to acetic acid (see Holzer pages 284-286). Accordingly, during a speedy and efficient fermentation, the pH drops quickly without excess lactic acid. Given the fact that there are performance difference between different strains of a bacterial organism and selecting the right strain to meet desired traits is well known (see Contreras-Govea page 3, top right column; and Holzer pages 284-286), it would have been obvious to a skilled artisan to have selected a strain of homofermentative lactic acid bacteria that will not produce excess lactic acid, as recited in the claim, which will lower the pH to a point that will inhibit the obligatory heterofermentative bacteria to a degree as claimed, and thus arrive at the claimed limitations.
As to the heterofermentative lactic acid bacterial strain: Contreras-Govea discloses of fermenting silage with at least one obligatory heterofermentative lactic acid bacteria (i.e., lactobacillus buchneri) and at least one homofermentative bacterial strain in order to provide silage with better dry matter recovery and aerobic stability (see Contreras-Govea page 1 right column to page 2 top left column). A fact that is also observed in Holzer (see Holzer page 285 right column to page 286 right column).
As to the homofermentative lactic acid bacterial strain: Contreras-Govea and Holzer disclose of fermenting silage with at least one obligatory heterofermentative lactic acid bacteria (i.e., lactobacillus buchneri) and at least one homofermentative bacterial strain (e.g., an enterococcus species) in order to provide silage with better dry matter recovery and aerobic stability (see Contreras-Govea page 1 left column to page 2 top left column; and Holzer page 285 right column to page 286 right column), and silage aerobic deterioration is directly related to excess lactic acid and silage aerobic stability is directly related to acetic acid content, where homofermentative lactic acid bacteria are known to form lactic acid and heterofermentative lactic acid bacteria (e.g., lactobacillus buchneri) are known to convert lactic acid to acetic acid (see Holzer pages 284-286), but Contreras-Govea and Holzer fail to disclose of the homofermentative lactococcus lactis bacteria; However, given the fact that the synergistic relations between homofermentative and heterofermentative silage inoculants are known (see Contreras-Govea page 2, top of left column; and Holzer pages 285-286), and there are performance difference between different strains of a bacterial organism and selecting the right strain to meet desired traits is well known (see Contreras-Govea page 3, top right column; and Holzer page 285 right column to page 286 right column), and since there are finite homofermentative lactic acid bacterial species that are present in silage and are commonly known and used to ferment silage (e.g., Lactococcus lactis) (see Holzer Box 1 on page 283), it would have been obvious to a skilled artisan to have selected a strain of lactobacillus lactis in order to optimize the synergistic effect imparted by the homofermentative and heterofermentative bacterial mixture in the silage inoculant, and thus arrive at the claimed limitations.
As to the lack of production of nisin of the homofermentative strain: Contreras-Govea discloses of fermenting silage with at least one obligatory heterofermentative lactic acid bacteria (i.e., lactobacillus buchneri) and at least one homofermentative bacterial strain (e.g., an enterococcus species) in order to provide silage with better dry matter recovery and aerobic stability (see Contreras-Govea page 1 left column to page 2 top left column). Since nisin is known to be produced by Lactococcus lactis and not enterococcus species (see Jones page 2). Contreras-Govea meets the claimed limitations.
As to the claimed lactobacillus buchneri recited in claims 1 and 16: Contreras-Govea fails to disclose of the specific strain of lactobacillus buchneri recited in claims 1 and 16; However, Contreras-Govea discloses that lactobacillus buchneri convert lactic acid to acetic acid, which is a good inhibitor of yeasts and molds that cause heating ad spoilage of silages, thus lactobacillus buchneri imparts aerobic stability (see Contreras-Govea page 1, right column). Given the fact that there are performance difference between different strains of a bacterial organism and selecting the right strain to meet desired traits is well known (see Contreras-Govea page 3, top right column), it would have been obvious to a skilled artisan to have selected a strain of lactobacillus in order to optimize the aerobic stability imparted by the lactobacillus buchneri bacteria, and thus arrive at the claimed limitations. The fact that Applicant determined the naturally occurring lactobacillus buchneri strain recited in claims 1 and 16 provided the optimum advantage sought, does not render the claimed invention patentable, as selecting an organism exhibiting optimum traits is clearly taught by the prior art as routine and conventional.
Regarding claims 5 and 37: While the homofermentative and heterofermentative bacterial combinations recited in the claims 5 and 37 are not specifically disclosed in Contreras-Govea and Holzer, given the fact that there are performance difference between different strains of a bacterial organism and selecting the right strain to meet desired traits is well known (see Contreras-Govea page 3, top right column; and Holzer pages 284-286), it would have been obvious to a skilled artisan to have selected a strain of homofermentative lactic acid bacteria that will not produce excess lactic acid, as recited in claims 5 and 37, which will lower the pH to a point that will inhibit the obligatory heterofermentative bacteria (see discussion, above), and thus arrive at the claimed limitations.
Response to Arguments
Applicant's arguments filed on June 29th 2026 have been fully considered but they are not persuasive.
Applicant traverses the restriction requirement, arguing on page 1 of the “Remarks”, the traversal is on the grounds that:
The Office Action does not contain any finding or allegation regarding the simplicity or complexity of concurrently searching and examining all of the presently claimed subject matter.
The newly presented claims are not drawn to a distinct invention, because there is no support on the record of using the claimed bacteria as probiotics, because the claims are drawn to a method of using the bacteria to inoculate silage and not as probiotics, as disclosed throughout the current specification.
It is respectfully submitted that these arguments are not found persuasive, because:
The reasons there would be serious search and/or examination burden if restriction was not allowed, because the inventions require a different field of search (for example, searching different electronic resources, or employing different search queries).
The fact that the current specification discloses the use of the bacteria as silage inoculants, but is silent with regards to the use of the bacteria as probiotics does not support the argument the claims are not distinct. The argument made in the Office Action mailed on April 2nd 2026, that the claimed bacteria can be used as probiotics, is an application of the rule explained in MPEP §806.05(h) to the current claims. MPEP §806.05(h), states that claims drawn to a product (e.g., silage inoculating bacteria) are distinct from claims drawn to a method of using that product (e.g., a method of inoculating plant material with the silage inoculating bacteria), if either one, or both, of the following can be shown: (1) the process for using the product as claimed (e.g., the method of inoculating a plant material with the silage inoculants) can be practiced with another materially different product, or (2) the product as claimed (i.e., the silage inoculant bacteria) can be used in a materially different process of using the product (e.g., be consumed in an adequate amount to attain health benefits, such as gut health). The materially different process of using the claimed product does not need to be disclosed in the application, the only stipulated requirement is that the materially different process of using the product (i.e., a method of using the silage inoculants as probiotics) is materially different than the claimed process of using the product (i.e., using the silage inoculants to inoculate plant material). Given the fact that a method of using the bacteria to inoculate plant material (i.e., combine the bacteria with plant material under certain conditions) is clearly different than a method of using the bacteria as probiotics (i.e., consume an adequate amount of the bacteria to attain health benefits, such as gut health), the claimed methods of using silage inoculants to inoculate plant material, and the silage inoculants, are distinct inventions pursuant to MPEP §806.05(h). Finally, as to the lack of evidentiary support, as set forth in MPEP §806.05(h), the Examiner must provide reasons and/or examples to support conclusions, but need not cite documents to support the restriction requirement.
Accordingly, The “election by original application” assessment is still deemed proper and is therefore made FINAL.
Applicant argues on pages 2-3 of the “Remarks” that the prior art references fail to render the claimed invention obvious, because Applicant provided evidence of the level of synergy (i.e., inhibition) provided by the claimed homofermentative and obligatory heterofermentative strains combinations, a level of synergy that is not taught by the prior art. The examiner respectfully disagrees.
Given the fact that the synergistic relations between homofermentative and heterofermentative silage inoculants are known (see Contreras-Govea page 2, top of left column; and Holzer pages 285-286), and there are performance difference between different strains of a bacterial organism and selecting the right strain to meet desired traits is well known (see Contreras-Govea page 3, top right column; and Holzer page 285 right column to page 286 right column), and since there are finite homofermentative lactic acid bacterial species that are present in silage and are commonly known and used to ferment silage (e.g., Lactococcus lactis) (see Holzer Box 1 on page 283), it would have been obvious to a skilled artisan to have selected a strain of lactobacillus lactis in order to optimize the synergistic effect imparted by the homofermentative and heterofermentative bacterial mixture in the silage inoculant, and thus arrive at the claimed limitations. Accordingly, the synergistic results observed by Applicant, were not unexpected. As set forth in MPEP §716.02(a)(I), “a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage”
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 ASSAF ZILBERING whose telephone number is (571)270-3029. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASSAF ZILBERING/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
