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 .
Claims 1-7,11-12,19-22 are under examination.
Response to Applicants Arguments/Amendments
The recently made amendments have altered the scope of the invention. Therefore, the former art rejections are withdrawn and new art rejections are put forth. The examiner has considered applicants arguments and the recent declaration dated November 26, 2025. Examiner addresses the applicable arguments put forward in applicants remarks and the declaration dated November 26, 2025 directly under the newly added art rejection. A terminal disclaimer was filed for the related Application 19/028,696 on November 26, 2025. Therefore, the obvious type double patenting rejection has been removed.
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.
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 1,3,7,11-12, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Cella (WO 2018165765) in view of Lee (WO 2022050797), Sanguansermsri et al. “Interspecies dynamics among bacteria associated with canine periodontal disease” Molecular Oral Microbiology, 33(1), 59-67 (2018), and Sheng-Wei (CN 106361683). Sheng-Wei is already of record. Lee US 20230381093 can be used as an English translation for Lee WO 2022050797.
Cella teaches a nutritional supplement or food product composition comprising a bacterial cell free fermentate (also known as a cell free supernatant) mixture containing peptides effective against biofilms. (Pages 2- 3, 9-11). Page 9 states that the bacteria supernatant/fermentate can be derived from one or more of the bacteria listed which also include Bacillus subtilis and Pediococcus pentosaceus (Page 9). Cella teaches that such supernatants can treat the Neisseria pathogen (Page 19).
It would have been obvious to have combined only the cell free supernatants/cell free fermentates from Bacillus subtilis and Pediococcus pentosaceus since both supernatants can both produce molecules/peptides that can inhibit unwanted pathogens and prevent/treat unwanted biofilm formation (Abstract and Pages 2,3, and 9 of Cella). MPEP 2144.06 recites "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine). Therefore, it would have been obvious to have combined the cell free supernatant from a Bacillus subtilis fermentation culture with a cell free supernatant from a Pediococcus pentosaceus fermentation culture to treat oral infections. Cella teaches that such a composition can be administered to dogs and/or cats (Page 7 of Cella), wherein each of the fermentates is in powder form (Page 11 of Cella) as in instant Claims 1,7,21 and 22
Cella does not provide a specific Bacillus subtilis species fermentate that is able to destroy/disrupt oral biofilms which cause halitosis/bad breathe and impact volatile sulfur compounds produced by Fusobacterium nucleatum. However, Lee teaches that the Bacillus subtilis ID-A05 strain fermentate can be used to treat cavities, periodontal disease, and halitosis and disrupt unwanted biofilms (Abstract, Examples 6, and Examples 10). Lee teaches that the Bacillus subtilis ID-A05 strain reduces the ability of strains to form a biofilm and substantially grow (Examples 6-7). Furthermore, Example 10 of Lee shows that treatment with Bacillus subtilis ID-A05 strain fermentate reduced the occurrence of VSCs produced by organisms such as Fusobacterium nucleatum It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the Bacillus subtilis ID-A05 strain supernatant/fermentate because it is able to effectively disrupt biofilm formation and reduce the production of VSCs (Examples 6-7 and 10). Because the evidence of Lee shows that the fermentate from Bacillus subtilis ID-A05 can successfully disrupt biofilm formation, there would have been a high expectation for success using Lee’s specific fermentate to destroy the oral biofilm and to have reduced the amount of VSCs as in instant Claims 1,7,21 and 22
Cella teaches that its fermentate can be used to treat Neisseria and/or its biofilms in the oral cavity but fails to identify a specific species of Neisseria. However, Sanguansermsri teaches that the main type of Neisseria pathogen that causes halitosis is Neisseria canis (Summary of Sanguansermsri, Pages 1-4). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used Cella’s fermentate composition to treat Neisseria canis . An artisan would have been motivated to have used Cella’s fermentate to treat halitosis resulting from the presence of Neisseria canis because Sanguansermsri teaches that Neisseria canis is one of the main causative agents of halitosis and periodontal diseases (Pages 1-4 of Sanguansermsri). Furthermore, Cella teaches that its cell free fermentate can successfully target Neisseria species (Page 7). There would have been a high expectation for success since Cella teaches that its fermentates can be used to treat Neisseria and target the oral biofilms that would inherently contain the Neisseria canis (Abstract and Pages 2,3, 9, and 19 of Cella) as in instant Claims 1,7,21 and 22
Cella does not teach how its composition affects levels of volatile sulfur compounds, including VSCs produced by Fuscobacterium nucleatum during an episode of halitosis. However, the elimination of VSCs by fermentates are taught in other reference such as Lee which teaches a specific strain of Bacillus subtilis that can target VSCs produced by Fuscobacterium nucleatum. Sanguansermsri teaches that Fuscobacterium nucleatum and P. gingivalis are prominent secondary colonizers of the biofilms which are responsible for VSCs/halitosis(Page 4 of Sanguansermsri). Neisseria canis can also be found in the oral/dental biofilms (Page 2 of Sanguansermsri). Cella teaches that strains such as Pediococcus pentosaceus can be successfully used to Pages 2- 3, 9-11 disrupt biofilms. If biofilms are disrupted, they will not be able to harbor halitosis causing organisms which are capable of producing VSCs. Without the halitosis causing organisms, the VSCs level would decrease. This phenomenon is also taught by Lee. Lee teaches a Bacillus subtilis fermentate that is able to disrupt biofilm formation (Examples 6-7). Lee also teaches that its Bacillus subtilis fermentate causes a significant decrease in VSC levels (Example 10 of Lee). Thus, Lee discloses a Bacillus subtilis strain that is able to disrupt a biofilm and also able to decrease VSC levels (Example 10 of Lee). Sheng Wei teaches that Pediococcus pentosaceus fermentate can be used to treat halitosis. A characteristic of halitosis is the increased levels of volatile sulfur compounds as in instant Claims 1,7,21 and 22
Dependent Claims taught by Cella
Cella teaches that starch can be included (Page 14, line 3) as in instant Claim 3. Cella further states that an overall dose of the composition can be 300 mg (Page 13, 2nd paragraph) as in instant Claim 11. Cella teaches that compositions comprising the therapeutic molecules described herein may comprises about 0.00001% to about 99% by weight of the active agent and any range therein between (Page 13, 2nd paragraph) as in instant Claim 12.
Dependent Claims taught by Sheng-Wei
Sheng-Wei teaches a bacterium inoculum between 1 to 1.5% (Examples 1-2 of Sheng-Wei) as in instant Claim 12.
Cella teaches that Pediococcus pentosaceus and Bacillus subtilis cell free supernatant can be used to successfully disrupt/destroy biofilms which would help to remove unwanted halitosis causing organisms from the oral cavity. Since Cella teaches that Pediococcus pentosaceus can break apart biofilms, the destruction of biofilms would lead to a reduction in VSCs produced by such strains as Fuscobacterium nucleatum.
Lee further states that disrupting biofilms by certain strains of Bacillus subtilis is associated with a decrease in VSCs produced by halitosis biofilm colonizers such as Fuscobacterium nucleatum. Furthermore, Sheng-Wei specifically teaches that Pediococcus pentosaceus can be used in a composition to treat halitosis (associated with an occurrence of unwanted VSCs) which would be produced by mainly Fusobacterium nucleatum and P. gingivalis as taught in Page 4 of Sanguansermsri. Thus, it would be obvious that the Pediococcus pentosaceus would also be capable of reducing the occurrence of volatile sulfur compounds (VSCs) produced by organisms including Fusobacterium nucleatum. The Pediococcus pentosaceus fermentate is capable of breaking apart biofilms which would also remove VSC producing microbes from the oral cavity, thus lowering the VSC levels. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology and microbiology. Therefore, the level of ordinary skill in this art is high.
Response to Applicants arguments—The examiner has considered the applicants remarks section, the recent amendments, and applicants affidavit dated November 26, 2025. Applicants have recently amended the claims to state that VSC production by F nucleatum specifically is inhibited. The examiner has withdrawn the former art rejection and put forth a new art rejection to address the recent claim amendments. Written description and enablement rejections were also added.
Both the remarks section and the affidavit argue that the composition recited in the claims is able to successfully inhibit volatile sulfur compounds produced by Fusobacterium nucleatum. Inhibition means that the volatile sulfur compounds produced from Fusobacterium nucleatum can be prevented. Figures 1-2 of applicants’ specification and the figures shown in the affidavit actually show a reduction (not inhibition) of volatile sulfur compounds because the VSCs are still present at a lower level.
The claim now recites inhibition of VSCs production by a canine oral microbe belonging to the species Fusobacterium nucleatum. This new amendment is discussed in both the declaration dated November 26, 2025 and applicants’ remarks section. The new rejections in this office action address the newly added claim limitations.
Anything that is able to disrupt/break apart the biofilm in the oral cavity will be able to decrease the number of biofilm colonizers capable of producing volatile sulfur compounds. The decrease number of biofilm colonizers will also decrease the level of volatile sulfur compounds since there will be less bacteria present to produce the volatile sulfur compounds.
Clams 1-4,6-7,11-12,19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Cella (WO 2018165765) in view of Lee (WO 2022050797), Sanguansermsri et al. “Interspecies dynamics among bacteria associated with canine periodontal disease” Molecular Oral Microbiology, 33(1), 59-67 (2018), Sheng-Wei (CN 106361683) and Berngruber (WO2023/011828). Berngruber and Sheng-Wei are already of record. Lee US 20230381093 can be used as an English translation for WO 2022050797.
Cella, Lee, Sanguansermsri, and Sheng-Wei apply as above to teach claims 1,3,7,11-12, and 21-22. The references fail to teach the additional components in the nutritional composition such as maltodextrin, fructooligosacchairdes, wheat meal, or animal derived protein. However, Berngruber teaches that such as nutritional compositions orally administered can have the following components: maltodextrin (Page 20, ln 32), fructooligosaccharide (Page 23, ln 12), wheat meal/wheat product (Page 21, ln 38), and an animal-derived protein (the various animal meals have protein) (Page 22, ln 16-18). It would have been obvious to an artisan of ordinary skill to have added the carrier materials taught in Berngruber. It would have been obvious to an artisan of ordinary skill at the time of effective filing to have included these components because they can be used in a carrier material that can be successfully orally administered (Page 18, ln 20-25 of Berngruber). Because these are successful carrier devices for oral administration, there would have been a high expectation for success (Page 18, ln 20-25 of Berngruber) as in instant Claims 2-4,19-20.
Dependent Claims taught by Berngruber
Berngruber teaches wherein each of the fermentates is lyophilized or spray-dried (Page 28, lns 15-20) as in instant Claim 6. Berngruber teaches wherein each of the fermentates is present in the nutritional supplement in an amount of 1 to 500 mg (Page 24, lns 23-27) as in instant Claim 11. Berngruber teaches wherein the bacterial fermentate mixture is present in the nutritional supplement at an incorporation rate of 0.01% to 10% w/w (Page 20, lns 23-25) as in instant Claim 12.
Cella teaches that Pediococcus pentosaceus and Bacillus subtilis cell free supernatant can be used to successfully disrupt/destroy biofilms which would help to remove unwanted halitosis causing organisms from the oral cavity. Since Cella teaches that Pediococcus pentosaceus can break apart biofilms, the destruction of biofilms would lead to a reduction in VSCs produced by such strains as Fuscobacterium nucleatum.
Lee further states that disrupting biofilms by certain strains of Bacillus subtilis is associated with a decrease in VSCs produced by halitosis biofilm colonizers such as Fuscobacterium nucleatum. Furthermore, Sheng-Wei specifically teaches that Pediococcus pentosaceus can be used in a composition to treat halitosis (associated with an occurrence of unwanted VSCs) which would be produced by mainly Fusobacterium nucleatum and P. gingivalis as taught in Page 4 of Sanguansermsri. Thus, it would be obvious that the Pediococcus pentosaceus would also be capable of reducing the occurrence of volatile sulfur compounds (VSCs) produced by organisms including Fusobacterium nucleatum. The Pediococcus pentosaceus fermentate is capable of breaking apart biofilms which would also remove VSC producing microbes from the oral cavity, thus lowering the VSC levels. An artisan would have been further motivated to have added the carrier components of Berngruber because they can allow such a composition to be orally administered. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology and microbiology. Therefore, the level of ordinary skill in this art is high.
Clams 1,3,5,7,11-12,21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Cella (WO 2018165765) in view of Lee (WO 2022050797), Sanguansermsri et al. “Interspecies dynamics among bacteria associated with canine periodontal disease” Molecular Oral Microbiology, 33(1), 59-67 (2018), Sheng-Wei (CN 106361683), Toledo (WO 2019118984). Toledo and Sheng-Wei are already of record. Lee US 20230381093 can be used as an English translation for WO 2022050797.
Cella, Lee, Sanguansermsri, and Sheng-Wei apply as above to teach claims 1,3,7,11-12, and 21-22. Cella teaches oral administration; however, Cella does not teach that the composition can be orally administered by using an extruded or injection molded dental chew. Toledo teaches nutritive composition containing a bacterial fermentate can be administered using an extruded or injection molded dental chew as taught in Paragraph 222 of Toledo. It would have been obvious to an artisan of ordinary skill in at the time of effective filing to have used the oral chew as taught in Toledo. An artisan would have been motivated to have used such a carrier because it can effectively be used for oral administration of a composition (Paragraph 222 of Toledo). There would have been a high expectation for success using the dental chew taught in Toledo since Toledo teaches that such a dental chew can be used to effectively orally deliver an agent (Paragraph 222 of Toledo) as in instant Claim 5.
Cella teaches that Pediococcus pentosaceus and Bacillus subtilis cell free supernatant can be used to successfully disrupt/destroy biofilms which would help to remove unwanted halitosis causing organisms from the oral cavity. Since Cella teaches that Pediococcus pentosaceus can break apart biofilms, the destruction of biofilms would lead to a reduction in VSCs produced by such strains as Fuscobacterium nucleatum.
Lee further states that disrupting biofilms by certain strains of Bacillus subtilis is associated with a decrease in VSCs produced by halitosis biofilm colonizers such as Fuscobacterium nucleatum. Furthermore, Sheng-Wei specifically teaches that Pediococcus pentosaceus can be used in a composition to treat halitosis (associated with an occurrence of unwanted VSCs) which would be produced by mainly Fusobacterium nucleatum and P. gingivalis as taught in Page 4 of Sanguansermsri. Thus, it would be obvious that the Pediococcus pentosaceus would also be capable of reducing the occurrence of volatile sulfur compounds (VSCs) produced by organisms including Fusobacterium nucleatum. The Pediococcus pentosaceus fermentate is capable of breaking apart biofilms which would also remove VSC producing microbes from the oral cavity, thus lowering the VSC levels. An artisan would have been further motivated to have added the carrier components of Toledo because they can allow such a composition to be orally administered. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology and microbiology. Therefore, the level of ordinary skill in this art is high.
Conclusion
All claims stand rejected.
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 LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638