Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Applicant’s preliminary amendment filed on 23 February 2026 is entered. Claim 3 is amended. Claims 3, 5-10, and 19-20 are pending, claims 7-10 and 19-20 are withdrawn, and claims 3 and 5-6 are under examination.
Priority
Receipt is acknowledged of the English translation of certified copies of IT102020000018895 filed 31 July 2020 as required by 37 CFR 1.55.
Therefore, the effective filing date is now 31 July 2020.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 recites that “Lactobacillus plantarum PBS067 is present in the composition in a percentage by weight on the total weight of the probiotic combination from 0.5% to 30%”, which is convoluted language that can be more concisely rephrased as: “Lactobacillus plantarum PBS067 is present in the composition from 0.5% to 30% by weight”. Claim 3 also recites similar limitations for Lactobacillus acidophilus PBS066 and Bifidobacterium lactis BL050, which are also convoluted for analogous reasons, and should be more concisely rephrased in the same manner. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 3 and 5-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a product of nature without significantly more.
The claims are drawn to the statutory category of a composition of matter (Step 1: Yes).
Claim 3 recites a composition comprising probiotic microorganisms Lactobacillus plantarum PBS067, Lactobacillus acidophilus PBS066, and Bifidobacterium lactis BL050, and at least one physiological acceptable excipient and/or carrier; claim 5 recites a medicament comprising the composition of claim 3; and claim 6 recites an immunostimulant comprising the composition of claim 3. Since claims 5 and 6 do not recite any other structural elements other than the composition of claim 3, claims 5 and 6 are interpreted as being structurally identical to the composition of claim 3.
Lactobacillus plantarum PBS067 is a naturally occurring bacteria isolated from healthy human intestinal mucosa, as evidenced by MiYe PBS067 (Lactobacillus plantarum PBS067, https://www.miye.care/en/pages/glossaire/lactobacillus-plantarum-pbs067, accessed 09 October 2025). Lactobacillus acidophilus PBS066 is a naturally occurring bacteria present in and isolated from human intestines, as evidenced by MiYe PBS066 (Lactobacillus acidophilus PBS066, https://www.miye.care/en/pages/glossaire/lactobacillus-acidophilus-pbs066, accessed 09 October 2025). Bifidobacterium lactis BL050 is a naturally occurring bacteria isolated from natural sources such as dairy products and human microbiota samples, as evidenced by MiYe BL050 (Bifidobacterium animalis subsp. lactis BL050, https://www.miye.care/en/pages/glossaire/bifidobacterium-animalis-subsp-lactis-bl050, accessed 09 October 2025).
The broadest reasonable interpretation of a physiological acceptable excipient and/or carrier includes naturally occurring compounds, such as water. Notably, the specification and the claims do not limit the excipient or carrier to be non-naturally occurring substances.
The closest natural counterpart of the instant compositions is Lactobacillus plantarum PBS067, Lactobacillus acidophilus PBS066, and Bifidobacterium lactis BL050 together in their natural habitats, such as the human intestines. Since the claims recite the compositions only comprise Lactobacillus plantarum PBS067, Lactobacillus acidophilus PBS066, and Bifidobacterium lactis BL050, the instant compositions would not have any markedly different characteristics as compared to the closest natural counterpart.
Therefore the instant invention recites the judicial exception of a product of nature (Step 2A Prong One: Yes).
This judicial exception is not integrated into a practical application and do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any active step of applying the instant natural compositions to improve a technology or field, to affect a particular treatment, or to affect a certain transformation of a particular article to a different state. The claims only recite the natural compositions themselves.
Therefore, the instant invention does not include any additional elements that amount to significantly more than the recited judicial exception of a product of nature, and so the instant invention is not patent eligible subject matter under 35 USC §101 (Step 2A Prong Two and Step 2B: No).
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.
Claims 3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Mezzasalma et al. (Orally administered multispecies probiotic formulations to prevent uro-genital infections: a randomized placebo-controlled pilot study, Arch Gynecol Obstet (2017) 295:163–172), and as evidenced by the instant specification.
Mezzasalma teaches probiotic compositions F_1 and F_2 comprising Lactobacillus plantarum PBS067, Lactobacillus acidophilus PBS066, and Bifidobacterium lactis PBS075 (Mezzasalma pg. 165 Tables 1 and 2). Mezzasalma teaches that Bifidobacterium lactis PBS075 was deposited under accession number DSM 25566 (Mezzasalma pg. 165 Tables 1 and 2). The instant strain Bifidobacterium lactis BL050 is disclosed as being deposited under accession number DSM 25566, as evidenced by pg. 4, lines 20-22 of the specification. Therefore, the Bifidobacterium lactis PBS075 taught in Mezzasalma is the same strain as the Bifidobacterium lactis BL050 recited in the instant claims. Both compositions F_1 and F_2 comprise physiological excipients inulin, silica, and talc (Mezzasalma pg. 165 Table 2).
Mezzasalma does not teach that the three strains are in one single composition together.
MPEP §2144.06(I) states "[i]t 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." Mezzasalma’s formulation F_1 comprising Lactobacillus acidophilus PBS066 and formulation F_2 comprising Lactobacillus plantarum PBS067 and Bifidobacterium lactis PBS075 (BL050) were both exhibit anti-microbial activity against pathogens responsible for vaginal dysbiosis and infections (Mezzasalma abstract). Since both F_1 and F_2 formulations exhibit the same beneficial effect, it would have been obvious to combine the two formulations together into a single composition which comprises Lactobacillus plantarum PBS067, Lactobacillus acidophilus PBS066, and Bifidobacterium lactis PBS075 (BL050).
Mezzasalma teaches Lactobacillus acidophilus PBS066 is present in F_1 in an amount of 10% by weight, Lactobacillus plantarum PBS067 is present in F_2 in an amount of 3% by weight, and Bifidobacterium lactis PBS075 (BL050) is present in F_2 in an amount of 15% by weight.
However, Mezzasalma does not teach the specific claimed weight proportions of Lactobacillus plantarum PBS067, Lactobacillus acidophilus PBS066, and Bifidobacterium lactis PBS075 (BL050) within a composition comprising a combination of the three strains.
MPEP §2144.05(II)(A) states “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. One of ordinary skill in the art would have found it obvious to start at the relative concentrations of Lactobacillus plantarum PBS067, Lactobacillus acidophilus PBS066, and Bifidobacterium lactis PBS075 (BL050) within the formulations F_1 and F_2, and then optimize the relative concentrations, with a reasonable expectation of success, with the objective of maximizing the combined composition’s beneficial effect of anti-microbial activity against pathogens responsible for vaginal dysbiosis and infections.
Response to Arguments
Applicant’s arguments, see remarks filed 23 February 2026, with respect to the 35 USC §112(a) enablement rejection of claims 3 and 5-6 regarding the public availability of biological materials Lactobacillus plantarum PBS067, Lactobacillus acidophilus PBS066, and Bifidobacterium lactis BL050 have been fully considered and are persuasive. Applicant provided the public availability statement for the strains deposited under Budapest Treaty, in the remarks pg. 7 sec. 4. The 35 USC §112(a) enablement rejection of claims 3 and 5-6 is withdrawn.
Applicant's arguments filed 23 February 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that the claimed strains do not exist in isolation in nature, nor do they exist in the relative weight proportions as claimed (Remarks pg. pg. 9 para. 1), isolation of the instant strains and differences in relative concentrations do not grant markedly different characteristics. The natural organisms themselves have not been modified in any way that would add any markedly different characteristics. The strains have not gained any non-natural components or capabilities that the strains would not possess in nature.
Regarding Applicant’s arguments that the specification’s Example 6 produced statistically significant immunomodulatory outcomes that are not observed in the natural counterpart (Remarks pg. 9 para. 2 through pg. 10 para. 4), the specification’s Example 6 does not compare the instant composition to the strains in nature; thus it cannot be reasonably concluded that the instant composition exhibits markedly different functional characteristics as compared to the natural counterparts.
Regarding Applicant’s arguments that the new limitation “a physiological acceptable excipient and/or carrier” recites a non-natural structural element that transforms the composition from a mere collection of bacteria into a manufactured pharmaceutical (Remarks pg. pg. 10 para. 5), the broadest reasonable interpretation of a physiological acceptable excipient and/or carrier includes naturally occurring compounds, such as water. Notably, the specification and the claims do not limit the excipient or carrier to be non-naturally occurring substances.
Regarding Applicant’s arguments that the claimed compositions may be formulated as capsules, sachets, sticks, tablets, granules, vials, drops, and other manufactured dosage forms, none of which exist in nature (Remarks pg. pg. 11 para. 1), Applicant’s asserted formulations of capsules, sachets, sticks, tablets, granules, vials, drops, and other manufactured dosage forms are not recited in the claims, so this does not amount to significantly more.
Regarding Applicant’s arguments that Mezzasalma does not disclose a composition comprising the specific combination of three strains now claimed, nor a physiologically acceptable excipient and/or carrier (Remarks pg. 12), as written in the new 103 rejection above, it would have been obvious to one of ordinary skill in the art to combine Mezzasalma’s formulation F_1 comprising Lactobacillus acidophilus PBS066 and formulation F_2 comprising Lactobacillus plantarum PBS067 and Bifidobacterium lactis PBS075 (BL050) together into a single composition which comprises Lactobacillus plantarum PBS067, Lactobacillus acidophilus PBS066, and Bifidobacterium lactis PBS075 (BL050) because both formulations exhibit anti-microbial activity against pathogens responsible for vaginal dysbiosis and infections (Mezzasalma abstract). It also would have been obvious to one of ordinary skill in the art to optimize the relative concentrations of the three claimed strains in the combined composition, with a reasonable expectation of success, with the objective of maximizing the combined composition’s beneficial effect of anti-microbial activity against pathogens responsible for vaginal dysbiosis and infections. Furthermore, Mezzasalma teaches that both compositions F_1 and F_2 comprise physiological excipients inulin, silica, and talc (Mezzasalma pg. 165 Table 2).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander M Duryee whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/Alexander M Duryee/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657