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 .
Claim Status
The amended claim sets filed 19 Feb 2025 and 27 Jun 2025 are acknowledged. In the claim set filed 19 Feb 2025, claims 2, and 6-10 were pending. Of those, claims 2 and 6 were currently amended, claims 7-10 were new. Claims 1 and 3-5 were cancelled, despite not complying with the MPEP. (See MPEP 714.II.C: “A claim being canceled must be indicated as "canceled;" the text of the claim must not be presented… When applicant submits the text of canceled or not-entered claims in the amendment, the Office may accept such an amendment…”)
In the claim set filed 27 Jun 2025, claims 2 and 6-10 are currently pending, although the claim set improperly lists 1-10 as pending. Of those, cancelled claim 5 is currently amended, and no claims are new. Claims 1-4 and 6-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 Jun 2025. No claims are listed as cancelled, although claims 1 and 3-5 were previously cancelled. This claim set does not comply with the MPEP. (See MPEP 714.II.C: “A canceled claim can be reinstated only by a subsequent amendment presenting the claim as a new claim with a new claim number.”)
Election/Restrictions
The previous requirement for restriction mailed 28 Apr 2025 is withdrawn because “Invention IV” as described in the restriction requirement was the only invention presented for examination. The claim set filed 19 Feb 2025 had cancelled all claims from Inventions I-III and only presented claims from Invention IV.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Applicant’s election without traverse of Group III (a method for inhibiting fimbrial growth, claim 5) in the reply filed on 27 Jun 2025 is not proper because claim 5 has been cancelled. The Examiner tried to call Attorney Tony Hom on 9 July 2025 to discuss the election, but was not able to reach them because the voicemail box was full.
In this action, claims 2 and 6-10 will be examined on the merits (“Invention IV”), because this is the only invention whose claims have not been cancelled.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 23 Jan 2024. It is noted, however, that applicant has not filed a certified copy of the CN202410092606.6 application as required by 37 CFR 1.55. The effective filing date used to search the art is 15 Nov 2024.
Information Disclosure Statement
The information disclosure statement filed 15 Nov 2024 fails to fully comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The NPL reference #1 was not submitted; instead, a different sequence was submitted; this reference has been struck through to indicate that it was not considered. The foreign patent document #1 is not in English and an English translation was only provided for the abstract; the IDS has been notated to reflect that only the translated abstract was considered. A signed copy of the IDS is enclosed with this action.
The information disclosure statements (IDSes) submitted on 19 Feb 2025 and 30 Mar 2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. For non-English foreign patent documents where an English translation was only provided for the abstract, the IDS has been notated to reflect that only the translated abstract was considered. A signed copy of the statements are attached with this action.
Claim Rejections - 35 USC § 112(b)
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 2 and 6-10 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.
Independent claim 2 reads “An application of a type 1 fimbrial repressor (T1FR) protein expressed by the T1fr gene coding the TIFR protein in preparation of drug for inhibiting intestinal colonization of an adherent-invasive Escherichia coli strain, wherein an amino acid sequence of the T1FR protein consists of SEQ ID NO: 2.” Independent claim 6 reads “An application of a T1FR protein expressed by a T1fr gene coding the T1FR protein in preparation of drug for inhibiting intestinal pathogenicity of an adherent-invasive Escherichia coli strain, wherein an amino acid sequence of the T1FR protein consists of SEQ ID NO: 2.” Dependent claims 7-10 limit a method of preparing the T1FR protein in the “application.”
The claims are indefinite because it is unclear what is being claimed: the T1FR protein consisting of SEQ ID NO: 2, a drug that was “prepared” in some manner by “applying” the T1FR protein in some manner, a method of making a drug, etc. Therefore, one of ordinary skill in the art would not be able to ascertain the scope being claimed. Also, attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See also MPEP 2173.05(q) for additional discussion of “use” claims.
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 2 and 6-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to “an application… in preparation of drug”. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). See also MPEP 2173.05(q) for additional discussion of “use” claims.
Art Not Relied Upon
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wang et al. (CN-117904144-A, published 19 Apr 2024; PTO-892) is prior art under 102(a)(1). Citations refer to locations in the English machine translation (PTO-892). As the inventors overlap, this reference may be eligible for a 102(b)(1)(A) exception. Wang teaches a T1FR nucleotide sequence shown in SEQ ID NO: 1 (pg. 2-3), which is identical to instant SEQ ID NO: 1 and encodes SEQ ID NO: 2 (alignment not shown for reasons of space). Wang teaches construction of an expression vector comprising SEQ ID NO: 1 and transformation into the LF82 strain of E. coli (Example 1.1 pg. 4), which results in production of the T1FR protein, and teaches that the LF82 strain is an adherent-invasive E. coli strain (Example 1.6 pg. 4). Wang teaches that the transformation inhibits the fimbriae on the E. coli (Example 1.3 pg. 4).
Wang et al. (US-20250051783-A1; filed 9/18/2024; PTO-892) is prior art under 102(a)(2). As the inventors overlap, this reference may be eligible for a 102(b)(2)(A) exception. The teachings of the claims are similar to Wang et al. (CN-117904144-A). This reference’s SEQ ID NO: 6 is identical to instant SEQ ID NO: 1 (alignment not shown for reasons of space).
Wang et al. (CN-116769802-A, published 19 Sep 2023; made of record in IDS field 1 Nov 2024) is prior art under 102(a)(1). Citations to Wang refer to locations in the English machine translation (PTO-892). Wang teaches a protein T1FR (gene ID: GW576_23830) that can effectively inhibit the generation of Escherichia coli type I pili (Abstract), and that this protein is also a type I fimbral repressor (pg. 3 par. 6). Wang teaches a “plasmid containing the T1FR gene is constructed and transferred [i.e. transformed] into delta ItrA delta TIfr strain” and the LF82 strain of E. coli (pg. 3 par. 6-7), which results in production of the T1FR protein.
Moreno-Mingorance et al. (2021; made of record in IDS filed 30 Mar 2025), teaches the ID GW576_23830 is a protein sequence that is identical to SEQ ID NO: 2 (alignment not shown for reasons of space).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645 /JANET L EPPS -SMITH/Supervisory Patent Examiner, Art Unit 1646