DETAILED ACTION
Acknowledgment and entry of the Amendment submitted on 7/23/26 is made.
Claims 1-4, 7, 8, 10, 11 and new claims 12-19 are currently pending.
Allowable Subject Matter
Claims 1-4, 7, 8, 11, 12-17 and 19 are allowed.
The Terminal Disclaimer filed 7/23/26 has been approved and overcomes the prior non-statutory double patenting rejection.
The amendment to the claims obviates all other outstanding 112 rejections.
The former rejection under 35 U.S.C. 103 as being unpatentable over Seo Jin Ho et al (KR 10-1731263 B1; May 2, 2017; provided by Applicants) in view of NCBI. Genbank accession no. WP_098448980.1 (19 October 2017; provided by Applicants) has been withdrawn. The instant specification demonstrates that the enzymes of SEQ ID NOs: 1 and 2 provide results that are not suggested by Ho or the NCBI sequence record. In the E. coli host of Example 5, the enzyme of SEQ ID NO: 1 produced approximately 122% of the 2'-fucosyllactose produced by FutC, and the enzyme of SEQ ID NO: 2 produced approximately 207% of the FutC level. In the Bacillus megaterium host of Example 8, the enzyme of SEQ ID NO: 2 produced approximately 40.3 mg/L of 2'-fucosyllactose as compared with approximately 18.8 mg/L for FutC, an improvement of about 2.1-fold. Example 9 reports approximately 150 mg/L using the SEQ ID NO: 2 enzyme in Bacillus subtilis and characterizes that result as an approximately seven-fold improvement over the conventional FutC amount reported in the specification. See Figure 3 and paragraphs [0064], [0068], and [0073] of the instant specification. The direct comparisons in Examples 5 and 8 isolate the feature that distinguishes the amended claims from Ho: the particular α-1,2-fucosyltransferase sequence. In each comparison, the SEQ ID NO: 2 enzyme and Ho's FutC enzyme were evaluated in the same host system, and the SEQ ID NO: 2 enzyme provided materially higher 2'- fucosyllactose production. The specification also demonstrates activity of the SEQ ID NO: 2 enzyme in multiple, taxonomically diverse hosts, including Escherichia coli, Corynebacterium glutamicum, Bacillus megaterium, Bacillus subtilis, and Saccharomyces cerevisiae. The claimed enzymes were selected from Biosafety Level 1 microorganisms, including Bacillus megaterium, whereas Ho relies on the conventional FutC enzyme from Biosafety Level 2 H. pylori. The invention therefore addresses both the productivity limitation and the safety concern associated with the enzyme used in Ho. These comparative results are not inherent properties of the host microorganism. They arise from the selected α-1,2-fucosyltransferase sequence and directly contradict the premise that the claimed enzyme would have been merely a predictable functional equivalent of FutC.
Rejection necessitated by Amendment to the Claims:
Claim Rejections - 35 USC § 112-2nd paragraph
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 10 and 18 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 10 and 18 are vague and indefinite due to the recitation of “NCBI Reference Sequence Accession No. WP 080473865.1.” A patent claim that identifies a sequence solely by a GenBank accession number is indefinite, as the underlying sequence data can change over time. While an accession number remains constant throughout the lifetime of a record, the actual sequence data associated with it can be updated. These updates can be made by the person who initially submitted the sequence, inventors or third parties. Accordingly, reference to the database sequence leaves the claim vague and indefinite. Appropriate correction is required.
Remarks by the Examiner regarding incorporation by reference:
In order to incorporate subject matter into this application by reference to this Genbank accession number the root words “incorporate by reference” must be present.
“Essential material” may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. However, MPEP 37 CFR 1.57 (g)(1): A correction … is permitted only if the application as filed clearly conveys an intent to incorporate the material by reference. A mere reference to material does not convey an intent to incorporate the material by reference.
With regards to Genbank accession numbers, a sequence which has only one version submitted prior to the filing date may be considered uniquely identified. If multiple versions of the sequence were submitted to the database prior to the effective filing date, the sequence may not be considered as uniquely identified.
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(f).
The sequences contained in claims 10 and 18 are considered essential material because it is necessary to meet the requirements of 35 U.S.C. 112. 37 CFR 1.57(c). Upon review, the examiner noticed that the specification did not include a sequence for the protein or for nucleic acid molecule which encoded the protein.
In order for applicants to comply with 1.57(c) they must:
•provide a copy of the essential material,
•amend the specification to include the essential material,
•providing a statement under 1.57(e) and/or (f).
If applicant adds the sequence, Applicant should also comply with the sequence requirements 37 CFR 1.821-1.825.
A claim that identifies a sequence by database accession number will usually be accepted as clear intent to incorporate the sequence by reference. This claim must be an original claim that is present as of the filing date.
Language identifying a source only in passing as other prior work of no identified relevance is unlikely to be incorporated by reference.
In summary:
To comply with 1.57(b)(1): Applicants need to add root words “incorporat(e) and “reference” to the specification and to address 1.57(b)(2) as to whether the sequence was uniquely identified (only one version present in GenBank prior to the filing date).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached at (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 9/8/26
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