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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 107 and 130 - 137 in the reply filed on December 17, 2025 is acknowledged.
Applicant additionally elects the single combination of bacteria to include elements (i) – (xv), (1) – (3), (5) and (7) – (8).
Claims 105, 108 – 113, 115 – 123 are canceled; claims 124 – 139 are added. New claims 124 – 129 align with group I; new claims 130 – 137 align with group II; new claims 138 – 139 align with group III.
Claims 104, 106 – 107, 114, 124 – 139 are pending; claims 104, 106, 114, 124 – 129, 138 – 139 are withdrawn as being drawn to non-elected subject matter; claims 107, 130 – 137 have been considered on the merits.
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 107 and 130 – 137 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.
Claims 107 and 131 appear to require specific strains of bacteria to be included in the compositions. Examples include Bacteroides_B vulgatus, Clostridium_M citroniae, Clostridium_M clostridioforme, Blautia_A obeum, Dorea longicatena B, Fusarium A sp., Eubacterium_E hallii and Coprococcus_B comes. 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 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.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 107, 130 – 137 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 107 and dependents are drawn to a bacterial composition however are rendered indefinite for reciting “Bacteroides_B vulgatus,” “Clostridium_M citroniae,” Clostridium_M clostridioforme,” “Blautia_A obeum,” “Dorea longicatena B,” and “Fusarium A sp.” as it is unclear if these are drawn to specific strains of bacteria or if they intend to encompass any strain of the recited species.
Claim 131 is rendered indefinite for reciting “Bacteroides_B vulgatus,” “Clostridium_M citroniae,” “Clostridium_M clostridioforme,” “Blautia_A obeum,” “Dorea longicatena B,” “Fusarium A sp.,” “Eubacterium_E hallii” and “Coprococcus_B comes” because it is unclear if these are drawn to specific strains of bacteria or if they intend to encompass any strain of the recited species.
Claim 136 is indefinite for reciting “comprises a pH-sensitive composition” as it is unclear whether the claim intends to further modify the bacterial composition of claim 107 or change the scope of the claim to a pH sensitive composition.
Claim 136 is further indefinite for reciting “a pH-sensitive composition” as the phrase is not adequately defined by the claim language or specification.
Prior Art Not Relied Upon
Goodman et al. (WO 2020/172492 A2, cited by US 2022/0118030) teaches compositions comprising combinations of bacteria (abstract, 0002, 0056, claims) to include various combinations of Collinsella aerofaciens, Bifidobacterium longum, Bacteroides ovatus, Bacteroides vulgatus, Alistipes putredinis, Clostridium citroniae, Clostridium clostridioforme, Clostridium ramosum, Ruminococcus (Blautia) obeum, Blautia coccoides, Dorea longicatena, Phascolarctobacterium faecium, Escherichia coli, Fusobacterium species, Barnesiella intestinihominis, Blautia luti, Bilophila wadsworthia, Blautia wexlerae, Clostridium bolteae, Akkermansia muciniphila, Parasuterella excrementinihominis, and Prevotella copri (Table 1).
The prior art does not teach compositions comprising Absiella innocuum as required by claim 107 and 131. Nor does the prior art teach including the species in combination with the additional required bacteria.
No claims are allowed.
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699