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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/12/2025 has been entered.
Status of claims
Claims 1-14 and 16-18 as amended and new claims 19 and 20 as filed on 12/12/2025 are currently pending.
Claims 16 and 18 remain/have been withdrawn from consideration as being directed to non-elected inventions (2 methods of using a product) by original presentation as explained in the previous office action mailed on 9/03/2025.
Claims 1-14 as amended on 12/12/2025 are now directed to a product.
Thus, claims 1-14 and 17 as amended on 12/12/2025 and new claims 19 and 20 as filed on 12/12/2025 are under examination in the instant office action.
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 1-14 and 17 as amended remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claims 1 and 17 recite a composition with a bacterial strain belonging to Lactobacillus rhamnosus. This strain is a naturally occurring bacteria having its natural features and/or effects including anti-viral effects. The specification does not describe genetic engineering of the claim-recited strain. Additional components including food or supplement additives are generic. Vitamins, minerals and omega 3 fatty are also natural products. The amounts of cells are not limited by weight or volume of composition; and the amount as per dose encompasses intended use. The claimed-recited compositions as a whole are combinations of natural products.
One of the alternative forms of a composition is a capsule. A simple capsule is a mere container which does not structurally and/or functionally change a natural product unlike an entero-coated capsule would.
Thus, this judicial exception is not integrated into a practical application because claimed elements in combination do not add a meaningful limitation or extra-solution to the claimed product, and the claimed product as a whole is nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-14 and 19 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by US 2016/0354418 (Quintens et al).
Notes with regard to the claimed strain: The claimed Lactobacillus rhamnosus strain VES001 is originally deposited as strain LMG S-28148 and then re-deposited again as BCCM/LMG P 33100 (see amendment to specification filed on 8/08/2025; see deposit receipts filed on 8/08/2025). Thus, 3 different designation numbers refer the same strain. The strain LMG S-28148 was deposited under terms of Budapest treaty; see publication US 2019/0000895 at par. 0029.
With regard to the prior art:
US 2016/0354418 (Quintens et al) discloses a composition comprising Lactobacillus rhamnosus strain LMG S-28148 (see par. 0127) and Bifidobacterium animalis spp lactis in a ratio 1:1 with total amount 5x109 CFU per dose (see par. 0127); thus, at least 107 CFU or as much as 0.5x109 CFU for each strain. The probiotic-containing compositions are is provided in a form of a tablet or a capsule (par. 0075) and covered with enteric coating (par. 0066).
Thus, the cited US 2016/0354418 (Quintens et al) anticipates claims 1, 6, 7, 14 and 19.
With respect to claims 2-5 and 9-13: claims are drawn to the intended use limitations. The structure of the cited composition is the same as claimed; and, thus, the cited composition is capable to perform the intended function. Moreover, it is administered orally (0073) to pregnant women (0069).
With respect to claim 8: The composition of the cited US 2016/0354418 (Quintens et al) comprises vitamins (0055, 0063), minerals (0063), and polysaccharide prebiotics (0065).
Thus, the cited US 2016/0354418 (Quintens et al) anticipates the claimed product.
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 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0000895 (Lienart Van Lidth De Jeude et al), US 11,026,913 (Morris et al) and US 2016/0354418 (Quintens et al).
The cited US 2019/0000895 (Lienart Van Lidth De Jeude et al) discloses a composition comprising Lactobacillus rhamnosus strain LMG S-28148 as a sole probiotic (abstract). The therapeutically effective dose is at least at least 107 CFU per dose and more (par. 0046). The therapeutic composition with the strain can be provided as a solid form or as a tablet (0036).
Although the cited document US 2019/0000895 does not disclose incorporation of vitamins and/or omega 3 fatty acids, it is well known to incorporate vitamins and/or omega 3 fatty acids into the Lactobacillus rhamnosus probiotic-containing composition for the expected health benefits at the very least with regard to general health and nutrition. For example: see US 11,026,913 (Morris et al) at col. 10, lines 11-20.
Although the cited document US 2019/0000895 does not disclose entero-coating, it is well known to provide entero-coating for oral probiotic-comprising compositions. For example: the cited US 2016/0354418 (Quintens et al) teaches that probiotic-containing compositions are provided in a form of tablets or capsules (par. 0075) and covered with enteric coating (par. 0066).
Therefore, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited reference. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments and contents of Declaration by Francois Heroufosse filed on 12/12/2025 have been fully considered but they are not all found persuasive.
Notes: Deposit requirement (deposit receipt and statement) for the claimed strain has been met in the papers filed on 8/08/2025. Thus, the rejection of claim 17 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement, was withdrawn.
The rejection of claim(s) under 35 U.S.C. 102 (a) (1) as anticipated by US 2012/0201798 (Kekkonen et al) or, in the alternative, under 35 U.S.C. 103 as obvious over US 2012/0201798 (Kekkonen et al) has been withdrawn in view of applicants’ arguments and contents of Declaration by Francois Heroufosse drawn to structural and functional differences between claimed strain and the cited prior art strain.
With regard to claim rejection under 35 U.S.C. 101 Applicants argue that entero-coating provides for markedly different characteristics from naturally occurring counterparts. Yet, claims recite an alternative form of a composition which is a simple capsule.
No claims are allowed.
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Vera Afremova
February 4, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653