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 1-2,5-6,13-18, and 21 are under examination.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 26, 2025 has been entered.
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 Therefore, the former art rejections are withdrawn and new art rejections are put forth.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 18/790,185 on August 2, 2025. However, the terminal disclaimer was later disapproved by OPLC because the form was not clear enough. Please submit a new terminal disclaimer form. A double patenting rejection will remain until an acceptable terminal disclaimer is submitted.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description Rejection:
Claims 1-2,5-6,13-18,21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
The body of the specification mentions that the fermentate composition recited in the claims can be used to inhibit volatile sulfur compound (VSC) production (Page 1, 1st paragraph of the summary in applicants’ specification). The last paragraph of page 6 of this same specification further states that the composition can be used to “reduce the abundance of one or more volatile sulfur compounds (VSCs) in an oral cavity of a subject. In some embodiments, the composition reduces the abundance of one or more volatile sulfur compound (VSC)-producing microorganism in a subject. In some embodiments, the one or more VSC-producing microorganisms are selected from the group consisting of Fusobacterium nucleatum, Neisseria canis, Bergyella zoohelcum, Prevotella intermedia, Porphyromonas canigingivalis Porphyromonas gingivalis, Tannerella forsythia, and Treponema denticola.” Applicants’ specification provides a summary that the fermentates recited in the claims can be used to reduce the abundance and/or inhibit VSC production.
The actual working examples/data presented in the specification do not support the claim limitations that the VSCs are completely inhibited by the fermentates in the composition. Figures 1-2,5,7,9, and 11 show the effects of the fermentate composition on VSC production by Fusobacterium nucleatum. Although the fermentate composition reduces VSCs, the fermentate composition does not completely inhibit/prevent the production of VSCs. Although the summary portion of the specification mentions that VSCs are inhibited, the actual data presented in the figures illustrates that VSCs are not completely inhibited. The figures actually show that volatile sulfur compounds are still present which contradicts the claim language that recites that VSCs are inhibited/prevented. Therefore, applicants have not satisfied the written description requirement for inhibiting VSCs.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
In Conclusion: The working examples/data provided by applicants in their specification show that VSCs are reduced but not completely inhibited. Therefore, applicants are not entitled to complete inhibition/prevention of VSCs by Fusobacterium nucleatum or any other bacteria.
The claimed invention as a whole is not adequately described if the claims require essential or critical elements which are not adequately described in the specification, and are not conventional in the art as of Applicants’ effective filing date. Possession may be shown by actual reduction to practice, clear depiction of the claimed invention in a detailed drawing, or by describing the invention with sufficient, relevant, identifying characteristics (as it relates to the claimed invention as a whole), such that one of skill in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641, 1646 (1998).
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483. In Fiddes, claims directed to mammalian FGFs were found to be unpatentable due to lack of written description for that broad class. The specification only provided the bovine sequence.
Enablement Rejection:
Claims 1-2,5-6,13-18,21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating one or more symptoms of halitosis in a subject in need thereof, the method comprising orally administering to the subject a nutritional supplement, dental supplement, or food product comprising a bacterial fermentate mixture, the bacterial fermentate mixture comprising: (i) a first fermentate that disrupts a biofilm of a canine oral microbe belonging to the species Neisseria canis, the first fermentate being a fermentate of a first bacterial strain that: (a) comprises a 16S rDNA sequence with at least 99% sequence identity to the nucleic acid sequence of SEQ ID NO: 1 and belongs to the species Bacillus subtilis; (b) comprises a 16S rDNA sequence with at least 99% sequence identity to the nucleic acid sequence of SEQ ID NO: 2 and belongs to the species Bacillus amyloliquefaciens, or (c) comprises a 16S rDNA sequence with at least 99% sequence identity to the nucleic acid sequence of SEQ ID NO: 4 and belongs to the species Bacillus pumilus; and (il) a second fermentate that reduces the production of one or more volatile sulfur compounds by a canine oral microbe belonging to the species Fusobacterium nucleatum, the second fermentate being a fermentate of a second bacterial strain comprising a 16S rDNA sequence with at least 99% sequence identity to the nucleotide sequence of SEQ ID NO: 5 and belonging to the species Pediococcus pentosaceus, wherein the nutritional supplement, dental supplement, or food product is substantially free of viable bacterial cells of the first bacterial strain and of the second bacterial strain, wherein the nutritional supplement, dental supplement, or food product reduces abundance of one or more VSCs by a canine oral microbe belonging to the species Fusobacterium nucleatum and disrupts a biofilm of a carrier oral microbe belonging to the species Neisseria canis in an oral microenvironment of the subject, does not reasonably provide enablement for a method of treating one or more symptoms of halitosis in a subject in need thereof by inhibiting volatile sulfur compound (VSC) production by a canine oral microbe belonging to the species Fusobacterium nucleatum and by disrupting a biofilm of a canine oral microbe belonging to the species Neisseria canis, the method comprising orally administering to the subject a nutritional supplement, dental supplement, or food product comprising a bacterial fermentate mixture, the bacterial fermentate mixture comprising: (i) a first fermentate that disrupts a biofilm of a canine oral microbe belonging to the species Neisseria canis, the first fermentate being a fermentate of a first bacterial strain that: (a) comprises a 16S rDNA sequence with at least 99% sequence identity to the nucleic acid sequence of SEQ ID NO: 1 and belongs to the species Bacillus subtilis; (b) comprises a 16S rDNA sequence with at least 99% sequence identity to the nucleic acid sequence of SEQ ID NO: 2 and belongs to the species Bacillus amyloliquefaciens, or (c) comprises a 16S rDNA sequence with at least 99% sequence identity to the nucleic acid sequence of SEQ ID NO: 4 and belongs to the species Bacillus pumilus; and (ii) a second fermentate that inhibits production of one or more volatile sulfur compounds ( VSCs) by a canine oral microbe belonging to the species Fusobacterium nucleatum, the second fermentate being a fermentate of a second bacterial strain comprising a 16S rDNA sequence with at least 99% sequence identity to the nucleotide sequence of SEQ ID NO: 5 and belonging to the species Pediococcus pentosaceus, wherein the nutritional supplement, dental supplement, or food product is substantially free of viable bacterial cells of the first bacterial strain and of the second bacterial strain, wherein the nutritional supplement, dental supplement, or food product inhibits production of one or more VSCs by a canine oral microbe belonging to the species Fusobacterium nucleatum and disrupts a biofilm of a canine oral microbe belonging to the species Neisseria canis in an oral microenvironment of the subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc. 8 USPQD2d 1217 (Fed. Cir. 1988). Whether undue experimentation is required is a conclusion reached by weighing several factors. These factors were outlined in Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and again in In re Wands, 8 USPQQ2d 1400 (Fed. Cir. 1988). While determining whether a specification is enabling, one considers whether the claimed invention provides sufficient guidance to make and use the claimed invention, if not, whether an artisan would require undue experimentation to make and use the claimed invention and whether working examples have been provided. When determining whether a specification meets the enablement requirements, some of the factors that need to be analyzed are: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and whether the quantity of any necessary experiment to make and use the invention based on the content of the disclosure is undue.
Nature of the Invention:
The claims recite a method of treating halitosis by administering a fermentate of Bacillus subtilis and a fermentate of Pediococcus pentosaceus. The claims recites that the method of treatment includes “inhibiting volatile sulfur compound (VSC) production by a canine oral microbe belonging to the species Fusobacterium nucleatum and by disrupting a biofilm of a canine oral microbe belonging to the species Neisseria canis.”
Breadth of the Claims:
The breadth of the claims are so broad that they encompass inhibiting all volatile sulfur compounds (VSCs) from Fusobacterium nucleatum.
Teachings from the Prior Art:
Figure 6 and Example 10 of Lee (WO 2022050797) disclose that its fermentate composition can significantly reduce VSCs but not completely inhibit/prevent them from being produced.
Applicants Specification/Guidance/Working Examples:
Figures 1, 2,5,7,9, and 11 in applicants specification fail to show complete inhibition. The specification only shows reduction of VSCs not complete inhibition/prevention.
Conclusion: Applicants specification only supports a reduction in VSCs, not a complete inhibition of VSC production.
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 1-2,5-6,13-18, and 21 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). Cella and Sheng-Wei are already of record. Lee US 20230381093 can be used as an English translation for WO 2022050797.
Cella teaches a method of minimizing oral bacterial infection and/or minimizing bacterial biofilm forming infection in a subject in need thereof, the method comprising orally administering to the subject a nutritional supplement or food product 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).
Cella does not provide a specific Bacillus subtilis species fermentate that is able to destroy/disrupt oral biofilms which cause halitosis/bad breathe. 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.
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 1-2, 5-6, 13-14,18 and 21
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 references. 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 taught by Lee. Lee teaches a fermentate that is able to disrupt biofilm formation (Examples 6-7). Lee also teaches that its fermentate causes a significant decrease in VSC levels (Example 10). This shows that that a strain that is able to disrupt a biofilm is also able to decrease VSC levels (Example 10 of Lee). Sheng Wei states that Pediococcus pentosaceus fermentate can be used to treat halitosis. A characteristic of halitosis is the increased levels of volatile sulfur compounds.
Cella teaches that Pediococcus pentosaceus 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 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 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 remove VSC producing microbes from the oral cavity, thus lowering the VSC levels.
Dependent Claims taught by Cella
Cell 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). Cella further states that an overall dose of the composition can be 300 mg (Page 13, 2nd paragraph) as in instant Claims 15-16. Page 10 states that the “molecules can be incorporated into a variety of substances for administration to a subject such as any type of animal and humans. For example, the molecules can be incorporated into any type of food product, nutritional supplement, or beverage for animal or human consumption (Page 10 of Cella) as in instant Claim 17.
Cella teaches the required cell free-supernatants/cell-free fermentates can be successfully used to treat oral infections such as halitosis by breaking apart the biofilms where the harmful halitosis microbes reside. An artisan would have been further motivated to have used the specific Bacillus subtilis fermentate composition of Lee since it can break down biofilm and reduce the expression of volatile sulfur compounds which cause halitosis. Sanguansermsri is applied to teach that both Fusobacterium nucleatum and Neisseria canis are located in the same region/same biofilm/same oral cavity. Sheng-Wei teaches that Pediococcus pentosaceus can be used in a composition to treat halitosis; halitosis is characterized by an increase in VSCs. It would be expected for Sheng-Wei’s treatment to reduce VSC levels once administered. These references teach that Bacillus subtilis and Pediococcus pentosaceus fermentates can not only disrupt biofilms but these fermentates can also reduce the level of VSCs. 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 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.
Applicants also argue in both applicants remarks the declaration dated November 26, 2025 that the references cited do not specifically discuss the disruption of a N. Canis biofilm specifically. Cella in the Oral Health Section states that the probiotic molecules in the supernatant can be used specifically to treat a bacterial infection such as Neisseria (Oral Health Treatment Section/Page19). Pages 1-3 of Cella state that the probiotic molecules present in the supernatant can be successfully used to disrupt unwanted biofilms in the oral cavity. Sanguansermsri states that N. canis is one of the primary colonizers of the oral biofilm (Page 2).
The pathogenic strains producing halitosis such as Neisseria canis and Fusobacterium nucleatum are all present in the same area/biofilm so they are all impacted when the oral biofilm is disrupted by Cella’s cell free supernatant.
In the Declaration dated November 26, 2005, applicants mention that “Cella mentions Pediococcus pentosaceus and Bacillus subtilis fermentates are only two in a list of 46 bacteria on page 9, and only mention the genus, Neisseria, not the species Neisseria canis….” Applicants argue that an artisan would not have been motivated to have selected those two strains to craft fermentates from a list of 46 strains to arrive at a composition that can both break down biofilms and reduce VSCs produced by Fusobacterium nucleatum.
The two strains are listed so they are still taught as being useful to produce fermentates that can disrupt biofilms. The destruction/disruption of biofilms would break down the biofilm so that some of the halitosis strains are removed. Furthermore, Lee presents compelling evidence that strains that are able to disrupt biofilms have lower levels of VSCs. Sheng-Wei even teaches that Pediococcus pentosaceus can be used to specifically treat halitosis/bad breath caused by VSCs.
In the declaration dated November 26, 2005, applicants further argue that the Pediococcus pentosaceus fermentate inhibited production of VSCs by F. nucleatum without killing the VSC-producing bacteria. This argument is not commensurate in scope with the instant set of claims because there is no mention on how the VSCs are inhibited/lowered specifically and whether the F. nucleatum are killed or remain alive.
Applicants further argue in the Declaration of November 2025 that not all the strains listed in the Cella reference are able to disrupt biofilms. In the declaration, applicants argue that Bacillus coagulans listed in Cella is unable to disrupt biofilms as shown in Example 1 of applicants’ instant specification.
Although Cella teaches this inoperable example, it still teaches the operable embodiment of Bacillus subtilis and Pediococcus pentosaceus fermentates disrupting biofilms. MPEP 716.07 states, “Where the affidavit or declaration presented asserts inoperability in features of the reference which are not relied upon, the reference is still effective as to other features which are operative. In re Shepherd, 172 F. 2d 560, 80 USPQ 495 (CCPA 1949).” Cella is still valid art that can be used in the instant rejection because the Bacillus subtilis fermentate and Pediococcus pentosaceus fermentate are operable embodiments.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-2,5-6,13-18, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,5,7,11-12,21-22 of copending Application No. 18/790,185 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1,7,21-22 of Application 18/790,185 disclose the same bacterial fermentate composition in the instant claims and also mention that such a composition can be used to treat halitosis. Thus, claims 1,7,21-22 of 18/790,185 disclose the same limitations recited in instant claims 1-8 and 18 of Application 19/028,696. Claims 13-14 of 19/028,696 correspond to instant claim 1 of 18/790,185 since claim 1 mentions canine treatment . Instant claim 15 of 19/028,696 corresponds to claim 11 of Application 18/790,185. Instant claim 16 corresponds to claim 12 of Application 18/790,185. Instant Claim 17 corresponds to claim 5 of Application 18/790,185. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638