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 IIB, a composition comprising two bacteria in the reply filed on October 23, 2025 is acknowledged.
Due to the confusing nature of the claim language, applicant was required to elect a single and specific bacteria or single and specific combination of bacteria, each bacteria population represented by a single SEQ ID NO. Applicant elected SEQ ID NO: 292 but did not elect a sequence for the second bacteria. For purposes of search, SEQ ID NO: 233 was selected by the examiner.
Applicant further elected the activity recited in claim 24 (i) wherein the bacteria are capable of reducing vancomycin resistant Enterococcus (VRE) or carbapenem resistant Enterococcus (CRE) carriage and restore colonization resistance in the GI tract of a mammal.
Claims 1 and 24 read on the elected subject matter.
Newly submitted claims 136 – 144 are considered directed to compositions that are independent and distinct from the elected invention. Specifically, claim 136 and its dependents change the elected composition from 2 bacteria to 16 unspecified “species or strains.” Despite the recitation of SEQ ID NOs in claim 143, it is iterated that the election requirement required a single and specific combination of bacteria which may be represented by a single or single and specific combination of SEQ ID NOs. Claim 143 fails to recite a single and/or single and specific combination of single SEQ ID NOs. Likewise, claim 144 fails to be drawn to the elected combination of 2 bacteria represented by a single or single and specific combination of bacteria, but requires any combination of 14 bacterial species or strains expressing any number of sequence variations within the recited 102 different sequences.
In a voice message from applicant’s representative, Adil Moghal, on October 24, 2025, it was clarified that the various claimed SEQ ID NOs within the various recited bacteria populations having 97% identity thereto correspond to the same species.
However, it is noted that the claimed SEQ ID NOs are disclosed as 16S-V4 sequence data which define OTUs (0121, 0255, 0424 of the published application), which are defined as closely related organisms that may or may not be the same species and/or strains. Moreover, a bacterial strain having at least 97% identity to SEQ ID NO: 292 may reflect two distinct but very closely related species. (See Beiko, p.674). Further, based on the current record, it is not clear whether the various claimed groups of SEQ ID NOs are limited to a single strain or even species. Thus, each of the claimed SEQ ID NOs are considered independent and distinct bacterial populations.
Claims 41, 44, 47 – 48, 68, 75, 82, 109 have been canceled; claims 136 – 144 are added; claims 1, 7, 9, 14, 16, 18, 21, 24, 31 – 32, 35, 40 and 136 – 144 are pending; claims 7, 9, 14, 16, 18, 21, 31 – 32, 35, 40 and 136 – 144 are withdrawn as non elected subject matter; claims 1 and 24 have been considered on the merits insofar as they read on the elected group.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 28, 2023 and October 23, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to because of the following:
Figure 4F is titled “Contin.” However no Figure 4 is included;
Figure 19J spans two pages however does not indicate a “Contin.’;
Figure 21 A – D appears to be missing a label for E and F.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph 0182, “sylitol” should read “xylitol.”
Appropriate correction is required.
Claim Interpretation
Based on both the voice mail from applicant’s representative specified above and Table A of the instant specification, elected SEQ ID NO: 292 is interpreted as representing Dorea longicatena and SEQ ID NO: 233 is interpreted as representing Blautia hominis.
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 and 24 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 represented by SEQ ID NO: 292 and 233 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.
However, a deposit may be made (e.g. Table A identifies strains 111-35 and KB1) under the terms of the Budapest Treaty, along with 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.
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 and 24 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 directed to a composition comprising two purified bacterial populations.
Step 2A Prong 1: Yes, the claims are directed to composition of bacteria which is a product of nature. Applicant isolates the claimed bacteria from human feces (0067, 0070, 0076, 0135, 0150 of the published application), indicating the bacteria are found together in their natural habitat in nature. Although the claims recite the bacteria are a “purified population” there is no evidence of record that indicates the purified populations display characteristics (e.g., function, activities, physical or chemical properties or structure) that are markedly different from their natural counterpart other than volume of CFUs.
Step 2A Prong 2: No, the claims do not recite any additional elements that integrate bacterial populations into a practical application. Although claim 24 recites the bacteria have the capability of reducing VRE and CRE carriage and restore colonization resistance in the GI tract of an animal, this activity is considered a law of nature or natural phenomena. See MPEP 2106.04(b) vii.
Step 2B: No, the claims fail to recite any additional elements that amount to significantly more than the two purified populations of bacteria.
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)(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.
(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 24 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Nandakumar et al. (WO 2019/036510, cited by US 11701394) as evidence by Sequence Search Result 12 US 16639492A.
Regarding claim 1, Nandakumar teaches compositions comprising Dorea longicatena and Blautia producta (col.2 line 60 – col.3 line 20, Table 2, claims). Per the sequence search comparison, the sequence for B. producta disclosed by Nandakumar shared 99.5% identity with the claimed SEQ ID NO: 233. Although the reference does not teach D. longicatena shares at least 97% with SEQ ID NO: 292, they are the same species. As such, they must also contain an identity at the species level of 97%.
Regarding claim 24, although the reference does not teach the bacteria have the claimed activity, they are regarded as the same species and would inherently also have the capability of reducing VRE and CRE carriage and restore colonization resistance in the GI tract of an animal.
Thus, the reference anticipates the claimed subject matter.
Claims 1 and 24 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Schneider et al. (US 2017/0354697) as evidenced by Sequence Search Results 1 and 2 US 15630088.
Regarding claim 1, Schneider teaches compositions comprising Dorea longicatena and Blautia producta (0009, 0020, 0030 – 0031, Table 1), wherein D. longicatena SEQ ID NO: 148 has 99.9% identity to the claimed SEQ ID NO: 292 and B. producta SEQ ID NO: 19 has 99.9% identity to the claimed SEQ ID NO: 233 (see search results 1, 2).
Regarding claim 24, Schneider teaches the compositions reduce VRE and CRE, or reduce VRE/CRE carriage (0082) and restore colonization in the GI tract (0125).
The reference anticipates the claimed subject matter.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, 9 – 11, 14 and 15 – 17 of U.S. Patent No. 11701394. Although the claims at issue are not identical, they are not patentably distinct from each other because both the issued patent and pending application claim compositions comprising Dorea longicatena and Blautia producta which share at least 97% identity with the claimed sequences based on search result 12 and the fact that 97% identity of the claimed sequences indicates the same species. Although the reference patent does not teach the bacteria have the claimed activity, they are regarded as the same species and would inherently also have the capability of reducing VRE and CRE carriage and restore colonization resistance in the GI tract of an animal.
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
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