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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 19, 2024; February 21, 2025; and August 13, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claims 1 – 6 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not provide clear evidence that the claimed biological material is known and readily available to the public; reproducible; and deposited per the deposit rules under 37 C.F.R 1.801 - 1.809.
Every patent must contain a written description of the invention sufficient to enable a person skilled in the art to which the invention pertains to make and use the invention. Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112. Courts have recognized the necessity and desirability of permitting an applicant for a patent to supplement the written disclosure in an application with a deposit of biological material which is essential to meet some requirement of the statute with respect to the claimed invention. See, e.g., Ajinomoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338, 1345-46, 56 USPQ2d 1332, 1337-38 (Fed. Cir. 2000), cert. denied, 121 S.Ct. 1957 (2001) (explaining how deposit may help satisfy enablement requirement); Merck and Co., Inc. v. Chase Chemical Co., 273 F. Supp. 68, 155 USPQ 139 (D. N.J. 1967); In re Argoudelis, 434 F.2d 666, 168 USPQ 99 (CCPA 1970). To facilitate the recognition of deposited biological material in patent applications throughout the world, the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure was established in 1977, and became operational in 1981. The Treaty requires signatory countries, like the United States, to recognize a deposit with any depository which has been approved by the World Intellectual Property Organization (WIPO).
The deposit rules (37 CFR 1.801 - 1.809) set forth examining procedures and conditions of deposit which must be satisfied in the event a deposit is required. The rules do not address the substantive issue of whether a deposit is required under any particular set of facts. (MPEP 2402).
Since the microorganisms Akkermansia, NITE BP-03622, NITE BP-03623 and NITE BP-03624 are recited in the claims, it is essential to the invention recited in those claims. It must therefore be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganism is not so obtainable or available, a deposit of the microorganism may satisfy the requirements of 35 U.S.C. § 112. The specification does not disclose a repeatable process to obtain the microorganism and it is not apparent if the microorganism is readily available to the public. Moreover, because no taxonomic information appears in the specification, it is not clear what the microorganism actually is.
However, since a deposit has been made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants, someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his/her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 C.F.R. § 1.808.
Claims 1 and 3 – 6 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 claim(s) 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 3 – 6 are drawn to an Akkermansia microorganism, wherein the microorganism has a nucleotide sequence having a particular percent homology to “a nucleotide sequence” in SEQ ID NOs:1, 2 or 3; and wherein the microorganism has 4 recited properties. These claims are considered genus claims that encompass a wide array of microorganisms. Initially, an Akkermansia having “a nucleotide sequence” of any one of SEQ ID NOs: 1, 2 or 3 encompasses nucleic acids that comprise the full-length sequence of the claimed SEQ ID NOs, the claimed percent homologies, or any portion of the SEQ ID NOs. Moreover, the claims encompass any Akkermansia having at least 2 consecutive nucleotides within the claimed sequences. The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of Akkermansia species and strains.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all species or strains that might exhibit the claimed properties in combination with the claimed 16S rRNA sequences, let alone those with at least 2 nucleotides in sequence therein. The possible variations of microorganisms include potentially millions of species or strains.
The instant disclosure describes only 3 strains of Akkermansia (WON 2089, WON 2090, WON 2093 corresponding to NITE BP-03622, NITE BP-03623, NITE BP-03624, respectively) that share a single specific sequence (e.g., SEQ ID NO: 3) wherein the strains demonstrate NOD2 agonistic activity (specification p.5). The specification states that this activity is not demonstrated in “the two known Akkermansia species” e.g., A. muciniphilia and A. glycaniphila, corresponding to SEQ ID NO:1 and 2 (p.5). The specification fails to describe any additional species or strains that have or do not have the claimed activities. Moreover, the specification compares the claimed activities in only 5 individual strains across potentially 3 species. Akkermansia comprises at least 31 species and data support the concept that the genetic diversity of Akkermansia should be taken into account in experimental settings (Molteni et al., p.1). The instant specification fails to consider this genetic diversity of Akkermansia while claiming any Akkermansia species or strain that has “a nucleotide sequence” withing any of SEQ ID NOs: 1, 2 or 3 and also the claimed properties.
The purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by them. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." The specification lacks sufficient variety of species of Akkermansia to reflect this variance in the genus since the specification does not provide any examples of such a genus of microorganisms. Accordingly, the specification fails to provide adequate written description for the genus of an Akkermansia having the claimed properties and minimal sequence identity and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention. Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these microorganisms, the specification does not describe the claimed microorganisms in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these microorganisms at the time of filing of the present application.
Thus, the written description requirement has not been satisfied.
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 – 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Step 1: Yes. The claims are drawn to a microorganism and compositions comprising the microorganism, which are drawn to a composition of matter.
Step 2A, Prong 1: Yes. The claims recite a microorganism having a particular 16S rRNA nucleotide sequence and 4 properties. The microorganisms are disclosed as isolated from human feces (p.8. examples), which are a product of nature, or a natural phenomenon.
Step 2A, Prong 2: No. The claims all fail to recite any additional elements other than the microorganism itself and therefore fail to recite additional features that integrate the judicial exception into a practical application.
Step 2B: No. The claims do not recite any additional elements and therefore fail to recite additional elements that amount to significantly more than the judicial exception.
Therefore, the claims are not subject matter eligible.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3 – 6 are rejected under 35 U.S.C. 102a2 as being anticipated by Ford et al. (US 2024/0148803) as evidenced by SEQ ID NO 3 Result 2, Ndongo et al. (2022), Ouwerkerk et al. (2016), and Segers et al. (2023).
Regarding claims 1 and 3, Ford teaches a microorganism belonging to Akkermansia and shares 100% sequence identity to the claimed SEQ ID NO: 3 (SEQ ID NO 3 Result 2, identified by PCT/US2022/016885, provisional application No. 63/150 544, SEQ ID 767). Although the reference does not teach the microorganism has the claimed properties, each off the properties are known characteristics of Akkermansia. In support, Ndongo teaches Akkermansia properties include gram-negative, catalase positive, oxidase negative and uses D-mannitol; Ouwerkerk lists properties of Akkermansia include, gram negative, strict anaerobes, oval shape (rod), catalase positive (p.4619); and Segers teaches Akkermansia have peptidoglycans that are recognized by NOD2 and activate antimicrobial response or have agonistic activity (p.15). Moreover, since the claims share the same 16S rRNA sequence, it must also have the same characteristics as claimed.
Regarding claims 4 - 6, Ford teaches the Akkermansia in compositions, wherein the microorganism is an active ingredient (claim 24 - 28, 33 - 34). While the reference does not teach the compositions can be used in the manner instantly claimed, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Therefore, the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 102/103
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claim 2 is rejected under 35 U.S.C. 102(a2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ford et al. (US 2024/0148803) as evidenced by SEQ ID NO 3 Result 2.
Regarding claim 2, Ford teaches a microorganism belonging to Akkermansia and shares 100% sequence identity to the claimed SEQ ID NO: 3 (SEQ ID NO 3 Result 2, identified by PCT/US2022/016885, provisional application No. 63/150 544, SEQ ID 767), or that of the claimed strains.
Ford does not teach the microorganism having the claimed deposit number. However, the reference discloses a strain that appears to be identical to the presently claimed strain. Consequently, the claimed strain appears to be anticipated by the aforementioned reference. However, even if the reference' s strain and the claimed strain are not one in the same and there is, in fact no anticipation, the reference strain would, nevertheless, have rendered the claimed strain obvious to one of ordinary skill in the art at the time the claimed invention was made, in view of the clear, close relationship between the strains as evidenced by their belonging to the same species and their essential characteristic.
Thus, the claim is rejected over the prior art.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699
