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 .
This office action is in regard to the application filed on February 19, 2021 and in response to a Request for Continued Examination filed on January 19, 2026.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 19, 2026 has been entered.
Status of Application
The amendment filed January 19, 2026 has been entered. However, the Examiner notes that the submitted claim set is the exact same as the claim set filed on December 19, 2025, which is already entered, as set forth in the Advisory Action dated January 2, 2026. In the same Advisory Action, the previous 112(b) rejections were withdrawn as Applicant’s amendments had overcome the rejections. In the most recent claim set, the claim status of claim 1 is indicated as “Currently Amended;” the claim status should be “Previously Presented” since the claim had already been amended and subsequently entered.
Claims 1 and 4-18 are currently pending in the application; claims 9-12 and 15 are withdrawn; claims 2 and 3 are canceled. Claims 1, 4-8, 13, 14, and 16-18 are hereby examined on the merits.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-8, 14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Bjerre (WO 2017/005601; listed on IDS dated May 19, 2021) in view of Ye et al. (“Research on the Harm of Spore-Forming Bacilli in Milk to Dairy products and Its Detection Methods,” Science and Technology Information, no. 17, 2006, p. 150; listed on IDS dated Nov. 14, 2023), herein after referred to as Ye.
Regarding claims 1, 4, 5, 7, 14, and 16-18, Bjerre teaches creating a fermented milk product comprising a lactic acid bacteria (LAB) starter culture and a strain of Bacillus bacteria (p. 5 lines 13-16). The LAB can be at least one of Lactococcus lactis, Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus (p. 10 lines 24-28). Bjerre also teaches that L. delbrueckii subsp. bulgaricus and S. thermophilus are typically used to make yogurt (p. 10, lines 28-30). The Bacillus culture can be B. subtilis (p. 5 lines 22-28). In particular, the B. subtilis culture can be B. subtilis var natto (p. 12 line 20).
Bjerre is silent as to that the sporulation-negative Bacillus strain improves the texture of the fermented dairy product compared to an otherwise identical method where the sporulation-negative Bacillus strain is not present. However, Bjerre does teach that adding a Bacillus strain improves texture (p. 35 para. 2). Bjerre is also silent as to that the fermented dairy product has a reduced acidification time compared to the mother strain as determined by the assay as described in Example 2.
In any case, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01.I. Since the two methods of the prior art and as claimed are substantially identical and both utilize a sporulation-negative Bacillus strain, they both must possess the same properties and characteristics as claimed (e.g., texture and reduced acidification time). Therefore, the method taught by Bjerre is considered to possess the improved texture and reduced acidification time as claimed because the method is substantially the same and thus must necessarily exhibit the same properties.
Bjerre does not teach sporulation-negative B. subtilis var natto, the test for spores, the original sporulation-positive mother strain of the sporulation-negative Bacillus bacteria, or the specific strains used.
Bjerre is silent as to the spore-forming potential of the Bacilli used.
Ye, in the same field of invention, teaches spore-forming Bacilli producing spores that survive heat sterilization. The resulting spores have negative effects on milk quality, including creating putrid and rancid tastes and unwanted gas production (p. 1 para. 3). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use sporulation-negative versions of B. subtilis var natto so as to avoid milk contaminated and spoiled by heat-resistant Bacilli spores.
The method of assessing a sporulation-negative strain as described in claim 1 is a definition of a sporulation-negative Bacillus. Any Bacilli labeled as sporulation-negative would have to produce no spores under these conditions. Therefore, it does not further limit the claim but rather merely defines what is considered sporulation-negative. For the purposes of examination, any Bacilli labeled sporulation-negative will be considered to produce no spores under these conditions claimed.
Ye teaches the detrimental effects of bacilli spores on milk products. While the sporulation-negative bacilli used above are not identified as those listed in claims 1, 4, and 16-18, the prior art teaches bacteria of the same genus and species performing similar functions. It is therefore reasonable to conclude that the prior art bacteria and the claimed bacteria are the same, unless shown otherwise. Furthermore, even though the prior art does not state that the sporulation-negative Bacilli come from a sporulation-positive mother strain, since the bacteria used are considered to be those in claims 1, 4, and 16-18, and the Bacilli of claims 1, 4, and 16-18 are derived from a mother strain, the Bacilli of the prior art can also be considered to come from a sporulation-positive mother strain. In addition, Bacillus sp. bacteria are naturally spore-forming so any sporulation-negative strain would have to have originally come from a sporulation-positive wildtype strain.
Regarding claim 6, Bjerre teaches that the fermented milk product is traditional yogurt (i.e., set or stirred yogurt) (p. 10, lines 28-30).
Regarding claim 8, Bjerre teaches that the fermented dairy product is cheese, sour cream, or cultured buttermilk (p. 17 lines 30-32). Since the instant claim identifies that sour cream, cheese, and buttermilk are all mesophilic fermented dairy products, the cheese, sour cream, and buttermilk taught by Bjerre are all considered to be mesophilic fermented dairy products as claimed.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bjerre (WO 2017/005601; listed on IDS dated May 19, 2021) in view of Ye et al. (“Research on the Harm of Spore-Forming Bacilli in Milk to Dairy products and Its Detection Methods,” Science and Technology Information, no. 17, 2006, p. 150; listed on IDS dated Nov. 14, 2023), as applied to claim 1 above, and further in view of Starter (“Starter Culture for Cheese Production,” Biotechnological Innovations in Food Processing, July 2018, pg. 77-112) and Mohammadou et al. (“Polyphasic approach to monitor the bacterial population dynamics in fermenting Hibiscus sabdariffa seeds to produce Mbuja,” International Journal of Current Microbiology and Applied Sciences, 2014, 3(6): 333-346), herein after referred to as Mohammadou; both Starter and Mohammadou were cited on PTO-892 dated Sep. 6, 2024.
Bjerre in view of Ye teach the method for producing a fermented dairy product as set forth above with regard to claim 1.
Bjerre and Ye teach the use of a LAB such as L. lactis in combination with a sporulation-negative strain of B. subtilis var natto to make a fermented milk product, as described above.
Bjerre also teaches that the addition of sporulation-negative B. subtilis var natto to milk alongside S. thermophilus and L. delbrueckii subsp. bulgaricus creates a fermented milk product. The fermented milk product, in this case, is understood to be sour milk as they are described as undergoing acidification, with a textural difference from a product not made with the Bacillus bacteria (p. 35, Example 9). However, the starter culture used is not a mesophilic starter culture.
Starter teaches that starter cultures for cheeses like gouda and cheddar contain mesophilic bacteria (p. 78, 4.2, para. 1).
Mohammadou teaches that Bacillus spp., which are being taken to include B. subtilis, are mesophilic bacteria used in starter cultures (p. 344, col. 2 para. 1). Total mesophilic bacteria increase as the number of Bacillus spp. increase, thereby meaning that Bacillus spp. are mesophilic bacteria (p. 342, col. 1 para. 4). It would have been obvious to one of ordinary skill in the art to have chosen the type of cheese they wanted and to have used a mesophilic starter culture to make that cheese. The starter culture used to make a fermented dairy product can include the mesophilic starter of B. subtilis as it is known to be used in mesophilic cultures.
Furthermore, Bjerre teaches that adding a Bacillus strain improves texture. Therefore, since the starter culture is not shown to be the texture-altering component, substitution would not be expected to product substantial changes in product texture. Bjerre also teaches that adding B. subtilis var natto changes the texture by affected the shear stress as measured with the TADM technique (p. 35 para. 2).
Response to Arguments
Applicant's arguments filed January 19, 2026 have been fully considered but they are not persuasive.
The Examiner additionally notes that the arguments in the Remarks filed January 19, 2026, are the same as those presented in the Response to Final Action dated December 19, 2025, the only difference being an additional paragraph about Bacillus spores. This paragraph is found on page 7 of the current “Remarks,” the paragraph starting with “Bacillus species are well-known.”
Applicant argues that the Examiner made an incorrect assumption about Ye and that one of ordinary skill in the art would have recognized that it is not the spores of the Bacillus strains, but the growth of the Bacillus strains themselves, that cause undesirable qualities in dairy products. Applicant also argues that it’s well known in the art that Bacillus species contribute to food spoilage and a person of skill in the art knows that the characteristics of Bacillus makes them undesirable in industrial production of fermented dairy products as the spores survive pasteurization and can lead to food-borne illness or food spoilage (Remarks, p. 7)
This argument is not persuasive. Ye teaches that the undesirable qualities are present in “fresh milk and yogurt” (p. 1 last paragraph), which is assumed to be pasteurized (i.e., heat sterilized) milk and yogurt. Since spore-forming Bacilli in milk forms heat-resistant spores, these spores would still be present in the fresh milk and yogurt after pasteurization, and thus, one of ordinary skill in the art would have recognized that it is the spores that are the cause of the undesirable qualities.
In either argument, whether it is the spores themselves or the germination thereof that cause the undesirable qualities, it is known and agreed upon that spore-forming Bacilli cause undesirable qualities. Ye is used in the rejection to teach that merely the presence of spore-forming Bacilli is undesirable, and as such, offers the motivation that one of ordinary skill in the art would have been motivated to use sporulation-negative versions of the bacteria. Therefore, it is a moot point to argue whether it is the spores or the germination thereof that cause undesirable qualities where Ye teaches and offers the motivation that the mere presence of spore-forming Bacilli is undesirable.
Applicant argues that it would have been unlikely for one of ordinary skill in the art to have combined the teachings of Ye with the teachings of Bjerre because Ye does not suggest a benefit to having Bacillus strains present in fermented dairy products and that one of ordinary skill in the art would have recognized that these strains are undesirable for these products (Remarks, p. 7).
This argument is not persuasive. Ye does not need to suggest a benefit to having Bacillus strains in fermented dairy products since that is already taught by Bjerre. Ye only needs to teach the sporulation aspect of the strains, which Ye does, as set forth above in the rejection.
In the absence of any further arguments with regard to the rejections of the additional dependent claims, the rejections of these dependent claims are maintained.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791