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.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 16, 2026 has been entered.
Response to Applicants Arguments/Amendments
Applicants have amended the instant set of claims. As a result of the amendments, the former rejections are withdrawn and new rejections are now put forward. All the references in the rejections are already of record.
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 Sheng-Wei (CN 106361683).
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 includes Bacillus subtilis and Pediococcus pentosaceus (Page 9). Cella teaches that such supernatants can treat pathogen infections associated with an oral and/or biofilm infection such as Neisseria (Pages 2 and 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 produce molecules/peptides that can inhibit unwanted pathogens and prevent/treat unwanted biofilm formation (Abstract and Pages 2,3, and 9 of Cella).
Sheng-Wei provides additional support for the effectiveness of a composition with Bacillus subtilis and Pediococcus pentosaceus. Sheng-Wei teaches a composition used to treat bad breadth that contains 6 fermentates (Technical field and Background of Sheng-Wei; Bottom of Page 1 of Sheng-Wei). Two of the 6 fermentates used include Bacillus subtilis and Pediococcus pentosaceus (Technical field and Background of Sheng-Wei; Bottom of Page 1 of Sheng-Wei). This illustrates that other references such as Sheng-Wei recognize that Bacillus subtilis and Pediococcus pentosaceus can be used to treat unwanted odors/bad breadth from an oral infection (Technical field and Background of Sheng-Wei; Bottom of Page 1 of Sheng-Wei). The teachings of Sheng-Wei provide further motivation for using a composition with Pediococcus pentosaceus and Bacillus subtilis fermentates because these components have been used previously to treat bad breadth (Technical field and Background of Sheng-Wei; Bottom of Page 1 of Sheng-Wei).
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 taught in Cella with a cell free supernatant from a Pediococcus pentosaceus fermentation culture as taught by Cella because both fermentates treat oral infections and conditions such as halitosis as in instant Claims 1,7,21-22.
The newly added claim limitations that recite “a composition that reduces the extent to which a live bacterium belonging to the species Fusobacterium nucleatum and present in a canine oral microenvironment can increase the concentration of VSCs in the canine oral microenvironment while present….a second fermentate that reduces the extent to which a live bacterium belonging to the species Fustobacterium nucleatum and present in the canine oral microenvironment can increase the concentration of VSCs in the canine oral microenvironment while present” are inherent characteristics of the cell free fermentate composition claimed and fail to further limit the structure and/or function of the fermentates in a way that would distinguish the fermentates from those taught by Cella and Sheng-Wei as in instant Claims 1,7,21-22.
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 supernatants can be used to successfully disrupt/destroy biofilms which would help to remove unwanted halitosis causing organisms such as Neisseria from the oral cavity. Shang-Wei further teaches that Pediococcus pentosaceus and Bacillus subtilis can be used to successfully treat bad breath. 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/Amendments
Applicants’ claims recites a composition with Bacillus subtilis fermentate and a Pediococcus pentosaceus fermentate. Cella teaches that both of these cell free fermentates may be used to treat pathogens responsible for oral infections (Pages 2 and 19). Sheng-Wei (CN 106361683) further teaches that an oral composition containing fermentates of Bacillus subtilis and Pediococcus pentosaceus, can be used to treat conditions such as bad breath (Technical field and Background of Sheng-Wei and Page 1). Shang-Wei’s composition includes Bacillus subtilis and Pediococcus pentosaceus which are used as deodorant/halitosis treatment agents thus providing additional support for using fermentates of Bacillus subtilis and Pediococcus pentosaceus in the claimed composition. Both the Cella and the Sheng-Wei references teach that Bacillus subtilis and Pediococcus pentosaceus fermentates can have beneficial properties to treat oral infections (Cella and Sheng-Wei) and bad breath (Sheng-Wei). Therefore, it would have been obvious to have combined Bacillus subtilis and Pediococcus pentosaceus fermentates in an oral formation. The claims just require the presence of the two fermentates.
The claims also now includes the additional limitations/amendments that the composition, “reduces the extent to which a live bacterium belonging to the species, Fusobacterium nucleatum and present in a canine oral microenvironment can increase the concentration of VSCs in the canine oral microenvironment while present.” This limitation is merely describing properties of the fermentates in the claims. These limitations do not add additional structures and/or functions to the fermentates.
Applicants specifically argue the following:
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The new claim amendments are reciting properties/characteristics of the Bacillus subtilis and Pediococcus pentosaceus fermentates. The description provided in the added limitations do not add structures or functions to the claimed composition that distinguish it from the fermentates taught in the prior art. While such limitations may be useful to add to method claims, the limitations do not add additional structure and/or function to the fermentates recited in the claims that would distinguish the claimed invention from the cell free supernatants taught by Cella.
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 Sheng-Wei (CN 106361683) and Berngruber (WO2023/011828).
Cella and Sheng-Wei apply as above to teach claims 1,3,7,11-12, and 21-22. Cella and Sheng-Wei teach oral compositions that can be administered. 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 supernatants 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. Furthermore, Sheng-Wei specifically teaches that Pediococcus pentosaceus and Bacillus subtilis fermentates can be used in a composition to treat halitosis (associated with an occurrence of unwanted VSCs). 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.
Response to Applicants Arguments
Applicants argue that Berngruber is deficient because it does not teach the limitations not taught by Cella/Sheng-Wei. Because Cella/Sheng-Wei is not defective, Berngruber is not deficient.
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 Sheng-Wei (CN 106361683), Toledo (WO 2019118984).
Cella 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 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 supernatants 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. Furthermore, Sheng-Wei specifically teaches that Pediococcus pentosaceus and Bacillus subtilis fermentates can be used in a composition to treat halitosis (associated with an occurrence of unwanted VSCs). An artisan would have been further motivated to have added the carrier components and or ways of carrier manufacture for oral administration 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.
Response to Applicants Arguments
Applicants argue that Toledo is deficient because it does not teach the limitations not taught by Cella/Sheng-Wei. Because Cella/Sheng-Wei is not defective, Toledo is not deficient.
Conclusion
All claims stand rejected.
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
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