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 .
DETAILED ACTION
Applicant’s response filed on 08/18/2025 is duly acknowledged.
Claims 2, 8, 9, 11-14, 17, 19, 21-28 and 31-34 were canceled by applicants.
Claims 1, 3-7, 10, 15, 16, 18, 20, 29, 30 and 35-41 as currently presented are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I (species A for strain “B. subtilis sp. MM-W1 with ATCC deposit number PTA-126789; directed to “A bacterial strain…” and “A feed…”) in the reply filed on 08/18/2025 (see REM, page 6) is acknowledged.
Accordingly, claims 35-39 (non-elected invention of Group II) have been withdrawn from further considerations.
Upon further considerations and search, the species requirement as previously made by the examiner, has been withdrawn. Both species A and B have been rejoined and examined on their merits in this action hereinafter.
Claims 1, 3-7, 10, 15, 16, 18, 20, 29, 30, 40 and 41 (elected Group I, without traverse; directed to directed to “A bacterial strain…” and “A feed…”) have been examined on their merits in this action hereinafter.
Priority
This application is a 371 of PCT/US2021/037056 (filed on 06/11/2021) which claims domestic benefit from a US PRO 63/038,304 filed on 06/12/2020.
Claim Objections
1. Claim 7 is objected to because of the following informalities: claim 7 recites the limitations “an EMS-causing bacterial pathogen” in line 2. The abbreviated term “EMS” should be recited in its full form, at least the first time it appears in the claim. Appropriate correction is required.
2. Claim 15 is objected to because of the following informalities: Claim 15 recites the abbreviation “AI-2”, which should be recited in its full form, at least the first time it appears in a claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
1. Claims 4 and 10 (as recited) 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. Claim 4 has been reproduced below:
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The recitation of claim 4 is confusing and incomplete because- first, it does not end with a period and therefore it is unclear what else is required by the claim after the recitation of components in the last line that ends with “; and”. Secondly, claim 4 ends with a semicolon with a conjunction “and”, which makes claim 4 incomplete in its recitation, and therefore the metes and bounds of the claimed invention cannot be properly determined by an artisan of ordinary skill in the art, and thus the claim is deemed indefinite. Since, claim 10 directly depends from claim 4, and does not remedy the above points, it is also rejected as being indefinite for the same reasons of record. Appropriate correction is required.
Claim 10 appears to recite a Markush group in the form of “selected from the group comprising…” (see line 2), which is ambiguous and confusing because it is unclear what other alternatives are to be included (because of “comprising” language) in the claimed group, and should be amended to recite in its proper form “selected from the group consisting of A, B, C, and D”, for instance. Appropriate correction is required.
2. Claim 30 as presented appears to recite a Markush group (see line 2), but does not end with conjunction “and” before the last component/alternative. The recitation is ambiguous and indefinite because it is unclear what other components were intended to be part of the group of alternatives separated by semicolons. The metes and bounds of the claimed invention does not appear to be properly defined. Claim 30 should be amended to provide for conjunction “and” before the last alternative (for instance, “…reduction in disease condition; and a gene editing function.”). Appropriate correction is required.
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.
1. Claims 1, 3-7, 10, 15, 16, 18, 20, 29, 30, 40 and 41 (as presented) 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 invention appears to employ biological materials in the form of specific bacterial strains (Bacillus subtilis sp. MM-W1 with ATCC patent deposit number PTA-126789; and Bacillus subtilis sp. MM-W2 with ATCC patent deposit number PTA-126790; see instant claim 1 and specification, page 1, section “DEPOSIT INFORMATION”, in particular). Since the biological materials are essential to the claimed invention they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological material is not so obtainable or available, the requirements of 35 U.S.C. §112 may be satisfied by a deposit of the biological material. The specification does not disclose a repeatable process to obtain the biological material and it is not apparent if the biological material is readily available to the public.
It is noted that applicant has deposited the biological material (instant specification, page 1, section “DEPOSIT INFORMATION”), but there is no indication in the specification as to public availability. If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological material (in the instant case, the bacterial strains Bacillus subtilis sp. MM-W1 with ATCC patent deposit number PTA-126789; and Bacillus subtilis sp. MM-W2 with ATCC patent deposit number PTA-126790) have been deposited under the Budapest Treaty and that the biological material will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §1.801-1.809, applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. §1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is also directed to M.P.E.P. § 2400 in general, and specifically to § 2411.05, as well as to 37 C.F.R. §1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination”. The specification should be amended to include this information, however, applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Appropriate correction is required.
Prior Art and 101 Issues
Claims 1, 3-7, 10, 15, 16, 18, 20, 29, 30, 40 and 41 appear to be free of 101 and prior art issues (see instant specification, page 9, 3rd paragraph; and page 39, Table 1, in particular).
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657