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 .
Status of the Claims
Claims 17-27, 29-34,36-41, 43, and 45-49 are pending (claim set as filed on 08/19/2026).
Priority
This application is a CON of application no.: 19/360,228 (unexamined), which is a CON of application no.: 16/916,399 (now abandoned), which is a CON of application no.: 15/759,381 (US Patent no. 10,736,924 B2), which is a 371 of PCT/EP2016/071327, which has a foreign application to EP 15184758.9 filed on 09/10/2015.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 08/19/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Withdrawal of Rejections
The response and amendments filed on 08/19/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s response to arguments section.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Interpretation
The MPEP 2103(I)(C) states “Examiners should begin claim analysis by identifying and evaluating each claim limitation. For products, the claim limitations will define discrete physical structures or materials. Product claims are claims that are directed to either machines, manufactures or compositions of matter”. Therefore, the claimed invention, as a whole, is directed to a product or a composition (i.e., the statutory category of invention).
The base claim’s recitation of the phrase “has been pasteurized at a temperature in a range of from 50°C to 100°C prior to administration” are verbs that imply or infer how the product composition was made or manufactured. However, since the claimed inventions, as a whole, are drawn to compositions as the statutory category of invention and not a methodology of making, these past tense verbs will be interpreted as product-by-process limitations (MPEP 2113) and thereby, said verbs are non-limiting wherein only the definitive structural features will be assessed.
Maintained Rejections
Claim Rejections - 35 USC §102, Anticipation
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 17-27, 29-34, 36-41, 43, and 45-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cani (WO 2014/076246 A1 - cited in the IDS filed on 01/30/2026).
Cani’s general disclosure relates to Akkermansia muciniphila or fragments thereof for treating a metabolic disorder in a subject in need thereof. The present invention also relates to a composition, a pharmaceutical composition and a medicament comprising Akkermansia muciniphila or fragments thereof for treating a metabolic disorder (see abstract & page 1).
Cani teaches administering an effective amount of Akkermansia muciniphila or a fragment thereof to the subject for either restoring a normal proportion of Akkermansia muciniphila in the gut of a subject in need thereof or treating a metabolic disorder (see pages 13-14, lines 15-3). Cani teaches Akkermansia muciniphila or fragments thereof for treating, or for use in treating, a metabolic disorder in a subject in need thereof wherein the metabolic disorder is selected from the group consisting of: overweight, obesity, and cancer (see page 4, lines 2-13, & page 9, lines 6 and 18, & page 15, lines 16-17).
Claim interpretation: as noted above in the claim interpretation section, the pasteurization features are product-by-process limitations and the claims are also interpreted under the broadest reasonable interpretation (BRI). Table 2 of the instant specification illustrates that the Akkermansia muciniphila may be “live” under certain conditions and duration. Therefore, the Cani reference teaches “viable cells of Akkermansia muciniphila are administered to the subject in need thereof” (see Cani at page 4, lines 18-19) which would read on the claims under BRI.
Regarding claims 18-21 and 49 pertaining to additional probiotic, Cani teaches Akkermansia muciniphila is co-administered with another probiotic strain and/or with one or more prebiotics (see page 5, lines 3-4, & pages 18-20, lines 20-6). Examples of bacterial probiotic strains include, but are not limited to Lactobacillus, Lactococcus, Bifidobacterium (see pages 18-19). Cani teaches yeast probiotics (see pages 19-20).
Regarding claims 22-25 pertaining to the prebiotic, Cani teaches the pharmaceutical composition, the cosmetic composition or the medicament further comprises a prebiotic including inulin and inulin-type fructans, oligofructose, xylose, arabinose, arabinoxylan, ribose, galactose, rhamnose, cellobiose, fructose, lactose, salicin, sucrose, glucose, esculin, tween 80, trehalose, maltose, mannose, mellibiose, mucus or mucins, raffinose, fructo-oligosaccharides, galacto-oligosaccharides, amino acids, alcohols, and any combinations thereof (see pages 20-21).
Other non-limiting examples of prebiotics include water-soluble cellulose derivatives, water-insoluble cellulose derivatives, unprocessed oatmeal, metamucil, all-bran, and any combinations thereof (see page 21).
Regarding claims 26-27, 29-33, 39-43, and 46 pertaining to the formulation, Cani teaches Akkermansia muciniphila or fragments thereof in association with an excipient. In one embodiment, said composition is a nutritional composition (see page 5, lines 7-9). A pharmaceutically acceptable excipient refers to an excipient that does not produce an adverse, allergic or other untoward reaction when administered to an animal, preferably a human. It may include any and all solvents, dispersion media, coatings, isotonic and absorption delaying agents and the like (see page 13, lines 5-14). Cani teaches “the form adapted to oral administration is a solid form selected from the group comprising tablets, pills, capsules, soft gelatin capsules, sugarcoated pills, or dispersing tablets, effervescent tablets or other solids” (see pages 21-22). Cani further teaches the composition, pharmaceutical composition, cosmetic composition or medicament is in the form of a food additive, drink additive, dietary supplement, nutritional product, medical food or nutraceutical composition (see pages 22-23, lines 16-29).
Regarding claims 34, 38, 45, and 47-48 pertaining to the amount, Cani teaches “an amount of Akkermansia muciniphila ranging from about 1.102 to about 1.1015 cfu, preferably from about 1.104 to about 1.1012 cfu, more preferably from about 1.105 to about 1.1010 cfu, and even more preferably from about 1.106 to about 1.109 cfu is administered to the subject. In another embodiment of the invention, an amount of Akkermansia muciniphila ranging from about 1. 104 to about 1.1012 cfu, more preferably from about 1.105 to about 1.1011 cfu, and even more preferably from about 1.106 to about 1.1010 cfu is administered to the subject” (see page 4, lines 21-27, & pages 14-15, lines 21-15).
Examiner’s Response to Arguments
Applicant’s amendments and arguments filed on 08/19/2026 have been fully considered but they are not persuasive and deemed insufficient to overcome the prior art of record.
In response to Applicant’s argument (addressing page 8 of the remarks) that Cani’s teaching of autoclaving (i.e., sterilizing) is not equivalent to the claim’s pasteurization limitations where “sterilization kills or inactivates all microorganisms … pasteurization merely reduces the number of viable microorganisms”: this argument is not persuasive because first, as noted above, the claims as a whole are drawn to a product composition and not a method of making. The pasteurization limitations are product-by-process limitations where the patentability of a product does not depend on its method of production (MPEP 2113). Notably, there is no structural requirement or recitation in the current claims of whether the Akkermansia muciniphila strain is a live strain, an inactivated strain, or killed strain. Nevertheless, the claims are interpretated under the broadest reasonable interpretation (BRI) standard where there is a temperature range of 50-100°C but no mention of any exposure duration. It could encompass 0.25 minutes or 90 days of pasteurization and thus, the claims are broad with respect to the viability of the strain. Table 2 of the instant specification at page 51 encompasses live strains under certain exposure duration and temperatures. Although, it should be noted that “Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim” (MPEP 2111.01(I)). Accordingly, since the prior art of Cani teaches viable cells of Akkermansia muciniphila, then it reads on the claimed strain under the broadest reasonable interpretation.
Maintained Rejections - Double Patenting
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 17-18, 26-27, 32, 34-35, 39, and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 4, and 6-8 of U.S. Patent no. 10,736,924 B2 (parent application no. 19/360,228). Although the claims at issue are not identical, they are not patentably distinct from each other because: ‘924 teaches a method for treating a metabolic disorder comprising administering a therapeutically effective amount of pasteurized Akkermansia muciniphila (see claims 1, 4, and 8 of ‘924). ‘924 teaches co-administered with another probiotic (see claim 6 of ‘924). ‘924 teaches an excipient (see claim 7 of ‘924).
Claims 17-18, 26-27, 32, 34, 39, and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 7, and 9-11 of co-pending Application no. 19/360,228. Although the claims at issue are not identical, they are not patentably distinct from each other because: Regarding claims 17, 26-27, 39, and 43, co-pending ‘228 teaches a method comprising orally administering pasteurized Akkermansia muciniphila (see claims 1 and 11). Regarding claim 18, co-pending ‘228 teaches another probiotic (see claim 9). Regarding claim 32, co-pending ‘228 teaches an excipient (see claim 10). Regarding claim 34, co-pending ‘228 teaches about 1.104 to 1.1012 cells (see claim 7).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 17-18, 22, 26-28, 34, 39, and 41-44 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over at least claims 1-3, 5, 8-9, 11, and 14 of co-pending Application no. 18/035,766. Although the claims at issue are not identical, they are not patentably distinct from each other because: co-pending ‘766 teaches a composition comprising pasteurized Akkermansia muciniphila (see claims 1-2 of ‘766). Co-pending ‘766 teaches additional probiotic, prebiotic, and yeast (see claim 5 of ‘766). Co-pending ‘766 teaches the formulations of nutraceutical, pharmaceutical, food composition, and tablet or pill (see claims 11 and 14 of ‘766).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 17-18, 22, 26-27, 34, and 39 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over at least claims 1-2, 7, and 9 of co-pending Application no. 18/684,681. Although the claims at issue are not identical, they are not patentably distinct from each other because: co-pending ‘681 teaches a method comprising orally administering pasteurized Akkermansia muciniphila (see claims 1-2, 7, and 12 of ‘681). Co-pending ‘681 teaches additional probiotic, yeast, prebiotic (see claim 9 of ‘681).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 17-18, 22, 26-27, 34, 39, 41, and 43 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over at least claims 1-2, 7, 9, and 12-13 of co-pending Application no. 18/684,682. Although the claims at issue are not identical, they are not patentably distinct from each other because: co-pending ‘682 teaches a composition comprising pasteurized Akkermansia muciniphila for oral administration (see claims 1-2, 7, and 12-13 of ‘682). Co-pending ‘682 teaches additional probiotic, yeast, and prebiotic (see claim 9 of ‘682).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims were allowed.
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 extension fee 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 date of this final action.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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