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 .
Claim Status
The amendment of 07/24/2026 has been entered. Claims 5 and 8-10 are pending (claim set as filed on 07/24/2026). Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. As previously acknowledged, election of invention Group Ill, drawn to a transformant, and of 'a homologous protein having a transporting activity for a fucose-containing carbohydrate and consisting of an amino acid sequence having an identity of 90% or more with the amino acid sequence represented by SEQ ID NO: 2' as protein species, was made without traverse in the reply filed on 01/12/2026.
Claim 5 is currently under examination and was examined on its merits.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 07/24/2026 has been received and considered.
Withdrawn Rejections
The previous rejections under 35 USC. § 101, 35 USC § 112(a), and the double patenting rejection as set forth in the previous Office action are withdrawn in light of the amendment filed on 07/24/2026.
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.
Claim 5 is newly rejected as necessitated by amendment 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 5 recites “wherein the ability to produce the 3-fucosyllactose is imparted by expressing a gene encoding an α1,3-fucosyltransferase” (claim 5, lines 2-3) which renders the claim indefinite since it is unclear if the E. coli transformant comprises the recited gene that encodes an α1,3-fucosyltransferase. One of ordinary skill in the art would not be able to determine the metes and bounds of claim 5, and thus, could not clearly determine how to avoid infringement of the claim.
In the interest of compact prosecution, the recited ability to produce a 3-fucosyllactose is treated as a property of the claimed transformant, and the transformant is considered capable of producing a 3-fucosyllactose if it has the instantly recited recombinant DNA encoding a protein consisting of an amino acid sequence of SEQ ID NO: 2.
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.
Claim 5 is newly rejected as necessitated by amendment under 35 U.S.C. 102(a)(1) as being anticipated by Tabata et al. (US 2010/0203592 A1, published on 08/12/2010), hereinafter ‘Tabata’,
Tabata’s general disclosure relates to a process for producing glutathione or
y-glutamylcysteine (see entire document, including abstract).
Regarding claim 5, please note the indefinite claim language and the Examiner’s interpretation discussed above under Claim Rejections - 35 USC§ 112 (b). The recited “ability to produce a 3-fucosyllactose” (claim 5, lines 1-3) is considered a property of the claimed E. coli transformant. Since it appears that the claim only requires that the transformant expresses the protein consisting of an amino acid sequence of SEQ ID NO: 2, a transformant is considered capable of producing a 3-fucosyllactose if it has the instantly recited recombinant DNA encoding a protein consisting of an amino acid sequence of SEQ ID NO: 2.
Pertaining to the transformant, Tabata teaches an Escherichia coli transformant comprising a plasmid comprising recombinant DNA encoding a protein consisting of an amino acid sequence of instant SEQ ID NO: 2 (see Example 2 including paragraphs [0211], [0215]-[0219]; see “ydeA gene, SEQ ID NO: 38” in Table 1 on page 14 and SEQ ID NO: 38 on pages 73-74; see Example 4, including paragraph [0225]). The Examiner notes that the translated amino acid sequence of positions 201-1388 of Tabata’s SEQ ID NO: 38 on pages 73-74 is identical with Tabata’s SEQ ID NO: 17 (396 aa, pages 36-37; paragraph [0040], see claim 1), which is identical with instant SEQ ID NO: 2, as shown below. It is noted that a plasmid is inherently autonomously replicable.
Tabata’s transformant implicitly has the ability to produce a 3-fucosyllactose since Tabata’s transformant comprises a plasmid comprising recombinant DNA encoding a protein consisting of an amino acid sequence of instant SEQ ID NO: 2, as required by claim 5.
Pertaining to the product by process limitations, i.e. the wherein clause, the recited process steps are given weight to the extent they impart structural limitations to the claimed transformant, i.e. a recombinant DNA encoding the protein (consisting of an amino acid sequence of SEQ ID NO: 2) is inserted into the E.coli cell. See MPEP 2113 (I).
GenCore version 6.5.3
Copyright (c) 1993 - 2026 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: April 15, 2026, 18:26:06 ; Search time 371 Seconds
(without alignments)
2077.701 Million cell updates/sec
Title: US-18-264-666-2
Perfect score: 1961
Sequence: 1 MTTNTVSRKVAWLRVVTLAV..........LIWSIIIFRRWPVTLEEQTQ 396
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 17250853 unique seqs, 1946533059 residues
Total number of hits satisfying chosen parameters: 17250853
Minimum DB seq length: 1
Maximum DB seq length: 1000000000
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 45 summaries
Database : Published_Applications_AA_Main:*
===================================
RESULT 1: 13 DUPLICATES:
===================================
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 1961 100.0 396 US-09-815-242-10164 2001-03-21 13 Identification of Essential Genes in Prokaryotes
ALIGNMENT:
Query Match 100.0%; Score 1961; Length 396;
Best Local Similarity 100.0%;
Matches 396; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MTTNTVSRKVAWLRVVTLAVAAFIFNTTEFVPVGLLSDIAQSFHMQTAQVGIMLTIYAWV 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MTTNTVSRKVAWLRVVTLAVAAFIFNTTEFVPVGLLSDIAQSFHMQTAQVGIMLTIYAWV 60
Qy 61 VALMSLPFMLMTSQVERRKLLICLFVVFIASHVLSFLSWSFTVLVISRIGVAFAHAIFWS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VALMSLPFMLMTSQVERRKLLICLFVVFIASHVLSFLSWSFTVLVISRIGVAFAHAIFWS 120
Qy 121 ITASLAIRMAPAGKRAQALSLIATGTALAMVLGLPLGRIVGQYFGWRMTFFAIGIGALIT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ITASLAIRMAPAGKRAQALSLIATGTALAMVLGLPLGRIVGQYFGWRMTFFAIGIGALIT 180
Qy 181 LLCLIKLLPLLPSEHSGSLKSLPLLFRRPALMSIYLLTVVVVTAHYTAYSYIEPFVQNIA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 LLCLIKLLPLLPSEHSGSLKSLPLLFRRPALMSIYLLTVVVVTAHYTAYSYIEPFVQNIA 240
Qy 241 GFSANFATALLLLLGGAGIIGSVIFGKLGNQYASALVSTAIA LLLVCLALLLPAANSEIH 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GFSANFATALLLLLGGAGIIGSVIFGKLGNQYASALVSTAIA LLLVCLALLLPAANSEIH 300
Qy 301 LGVLSIFWGIAMMIIGLGMQVKVLALAPDATDVAMALFSGIFNIGIGAGALVGNQVSLHW 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LGVLSIFWGIAMMIIGLGMQVKVLALAPDATDVAMALFSGIFNIGIGAGALVGNQVSLHW 360
Qy 361 SMSMIGYVGAVPAFAALIWSIIIFRRWPVTLEEQTQ 396
||||||||||||||||||||||||||||||||||||
Db 361 SMSMIGYVGAVPAFAALIWSIIIFRRWPVTLEEQTQ 396
DUPLICATES:
…
US-12-594-928A-17
Filing date in PALM: 2009-10-06
Sequence 17, US/12594928A
Publication No. US20100203592A1
GENERAL INFORMATION
APPLICANT: Tabata et al.
TITLE OF INVENTION: Process for production of glutathione or gamma-glutamylcysteine
FILE REFERENCE: 705523
CURRENT APPLICATION NUMBER: US/12/594,928A
CURRENT FILING DATE: 2010-03-31
PRIOR APPLICATION NUMBER: PCT/JP2008/056759
PRIOR FILING DATE: 2008-04-04
PRIOR APPLICATION NUMBER: JP2007-99957
PRIOR FILING DATE: 2007-04-06
NUMBER OF SEQ ID NOS: 108
SEQ ID NO 17
LENGTH: 396
TYPE: PRT
ORGANISM: Escherichia coli
Claim 5 is newly rejected as necessitated by amendment under 35 U.S.C. 102(a)(1) as being anticipated by Jennewein et al. (US 201810305724 A1, published on 10/25/2018), hereinafter ‘Jennewein’, as evidenced by Uniprot ("P31122 SOTB_ECOLI", published in 1997, retrieved from https://www.uniprot.org/uniprotkb/P31122/entry, 7 pages), hereinafter ‘Uniprot’.
Jennewein’s general disclosure relates to “methods for the production of oligosaccharides in genetically modified bacterial host cells, as well as to the genetically modified host cells used in the methods”, wherein “the genetically modified host cell comprises
at least one recombinant glycosyltransferase, and at least one nucleic acid sequence coding for a protein enabling the export of the oligosaccharide” (see entire document, including abstract).
Regarding claim 5, please note the indefinite claim language and the Examiner’s interpretation discussed above under Claim Rejections - 35 USC§ 112 (b). The recited “ability to produce a 3-fucosyllactose” (claim 5, lines 1-3) is considered a property of the claimed E. coli transformant. Since it appears that the claim only requires that the transformant expresses the protein consisting of an amino acid sequence of SEQ ID NO: 2, a transformant is considered capable of producing a 3-fucosyllactose if it has the instantly recited recombinant DNA encoding a protein consisting of an amino acid sequence of SEQ ID NO: 2.
Pertaining to the transformant, Jennewein teaches an Escherichia coli transformant comprising a plasmid comprising recombinant DNA encoding a protein consisting of an amino acid sequence of instant SEQ ID NO: 2 (“acc. no. AAC74601”; paragraphs [0026], [0049], [0054], [0060], [0127], [0129]; see “pINT-ydeA (SeqID27) … ydeA of E. coli MG 1655 integrated into vector pINT” in Table 2 on page 12). Please note that Jennewein’s YdeA of E. coli MG1655 (“acc. no. AAC74601”; paragraphs [0049], [0129]) is identical with the amino acid sequence of instant SEQ ID NO: 2, as evidenced by Uniprot (see alignment of instant SEQ ID NO:2 (Qy) with the amino acid sequence of YdeA from E.coli MG1655 taught by Uniprot (Db) below). It is noted that a plasmid is inherently autonomously replicable.
Jennewein’s E. coli transformant implicitly has the ability to produce a 3-fucosyllactose since Jennewein’s transformant comprises a plasmid comprising recombinant DNA encoding a protein consisting of an amino acid sequence of instant SEQ ID NO: 2, as required by claim 5.
Jennewein teaches wherein “the genetically modified host cell comprises at least one recombinant glycosyltransferase” (see abstract), wherein the recombinant glycosyltransferase can be α-1,3-fucosyltransferase (paragraph [0027]). Since Jennewein’s transformant comprises a gene encoding an α1,3-fucosyltransferase, it is able to produce a 3-fucosyllactose.
Pertaining to the product by process limitations, i.e. the wherein clause, the recited process steps are given weight to the extent they impart structural limitations to the claimed transformant, i.e. a recombinant DNA encoding the protein (consisting of an amino acid sequence of SEQ ID NO: 2) is inserted into the E.coli cell. See MPEP 2113 (I).
GenCore version 6.5.2 Copyright (c) 1993 - 2026 Biocceleration Ltd.OM protein - protein search, using sw modelRun on: April 17, 2026, 13:14:25 ; Search time 1 Seconds (without alignments) 0.157 Million cell updates/secTitle: US-18-264-666-2Perfect score: 1961Sequence: 1 MTTNTVSRKVAWLRVVTLAV..........LIWSIIIFRRWPVTLEEQTQ 396Scoring table: BLOSUM62 Gapop 10.0 , Gapext 0.5Searched: 1 seqs, 396 residuesTotal number of hits satisfying chosen parameters: 1Minimum DB seq length: 0Maximum DB seq length: infPost-processing: Minimum Match 0% Maximum Match 100% Listing first 50 summariesDatabase : AASEQ2_04172026_091407.fasta:* SUMMARIES %Result Query No. Score Match Length DB ID Description ---------------------------------------------------------------------------- 1 1961 100.0 396 1 AASEQ2_04172026_091407 ALIGNMENTSRESULT 1AASEQ2_04172026_091407 Query Match 100.0%; Score 1961; DB 1; Length 396; Best Local Similarity 100.0%; Matches 396; Conservative 0; Mismatches 0; Indels 0; Gaps 0;Qy 1 MTTNTVSRKVAWLRVVTLAVAAFIFNTTEFVPVGLLSDIAQSFHMQTAQVGIMLTIYAWV 60 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||Db 1 MTTNTVSRKVAWLRVVTLAVAAFIFNTTEFVPVGLLSDIAQSFHMQTAQVGIMLTIYAWV 60Qy 61 VALMSLPFMLMTSQVERRKLLICLFVVFIASHVLSFLSWSFTVLVISRIGVAFAHAIFWS 120 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||Db 61 VALMSLPFMLMTSQVERRKLLICLFVVFIASHVLSFLSWSFTVLVISRIGVAFAHAIFWS 120Qy 121 ITASLAIRMAPAGKRAQALSLIATGTALAMVLGLPLGRIVGQYFGWRMTFFAIGIGALIT 180 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||Db 121 ITASLAIRMAPAGKRAQALSLIATGTALAMVLGLPLGRIVGQYFGWRMTFFAIGIGALIT 180Qy 181 LLCLIKLLPLLPSEHSGSLKSLPLLFRRPALMSIYLLTVVVVTAHYTAYSYIEPFVQNIA 240 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||Db 181 LLCLIKLLPLLPSEHSGSLKSLPLLFRRPALMSIYLLTVVVVTAHYTAYSYIEPFVQNIA 240Qy 241 GFSANFATALLLLLGGAGIIGSVIFGKLGNQYASALVSTAIA LLLVCLALLLPAANSEIH 300 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||Db 241 GFSANFATALLLLLGGAGIIGSVIFGKLGNQYASALVSTAIA LLLVCLALLLPAANSEIH 300Qy 301 LGVLSIFWGIAMMIIGLGMQVKVLALAPDATDVAMALFSGIFNIGIGAGALVGNQVSLHW 360 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||Db 301 LGVLSIFWGIAMMIIGLGMQVKVLALAPDATDVAMALFSGIFNIGIGAGALVGNQVSLHW 360Qy 361 SMSMIGYVGAVPAFAALIWSIIIFRRWPVTLEEQTQ 396 ||||||||||||||||||||||||||||||||||||Db 361 SMSMIGYVGAVPAFAALIWSIIIFRRWPVTLEEQTQ 396Search completed: April 17, 2026, 13:14:25Job time : 1 secs
Response to Arguments
Applicant has traversed the previous rejections under USC § 102 (a)(1) in the reply filed on 07/24/2026. Tabata and Jennewein are still relied upon in the above rejections. Applicant's arguments regarding Tabata and Jennewein filed on 07/24/2026 have been fully considered but they are not persuasive.
In Applicant’s reply, Applicant states that “Tabata entirely fails to teach an Escherichia coli transformant expressing an α1,3-fucosyltransferase”, and that “Jennewein does not disclose or suggest the specific combination required by presently pending Claim 5: an Escherichia coli transformant expressing an α1,3-fucosyltransferase in combination with the specific protein consisting of SEQ ID NO: 2 to selectively produce and export 3-fucosyllactose” (remarks, page 4).
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the feature upon which Applicant relies (i.e., an Escherichia coli transformant expressing an α1,3-fucosyltransferase) is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As discussed above under Claim Rejections - 35 USC § 112 (b), it is unclear if the recited transformant in claim 5 comprises a gene encoding an α1,3-fucosyltransferase, and it appears that the claim only requires that the transformant expresses the protein consisting of an amino acid sequence of SEQ ID NO: 2. As such, a transformant is considered capable of producing a 3-fucosyllactose if it has the instantly recited recombinant DNA encoding a protein consisting of an amino acid sequence of SEQ ID NO: 2.
Because Tabata and Jennewein each teach the claimed Escherichia coli transformant having the recited plasmid comprising recombinant DNA encoding an amino acid sequence of instant SEQ ID NO: 2, Tabata’s and Jennewein’s transformants are considered capable to produce a 3-fucosyllactose, as discussed above under Claim Rejections - 35 USC § 102. Jennewein teaches wherein “the genetically modified host cell comprises at least one recombinant glycosyltransferase” (see abstract), wherein the recombinant glycosyltransferase can be α-1,3-fucosyltransferase (paragraph [0027]). Since the transformant comprises a gene encoding an α1,3-fucosyltransferase, it is able to produce a 3-fucosyllactose.
Applicant states that “nothing in Tabata teaches or suggests that its transporter could function as an exporter for 3-fucosyllactose” (remarks, page 4).
The Examiner responds that since Tabata teaches the claimed E. coli transformant and its components, Tabata’s transformant and its components inherently have the same properties as the claimed transformant.
In response to Applicant's argument that Jennewein fails to show certain features of the invention, the Examiner notes that the features upon which Applicant relies, i.e. to selectively produce and export 3-fucosyllactose, are not recited in the rejected claim(s). As discussed above, limitations from the specification are not read into the claims. It is further noted that “to selectively produce and export 3-fucosyllactose” is considered an intended use of the transformant. Please note that if an intended use of a claimed invention does not impart a structural limitation on the product itself, no patentable weight is given to the intended use. See MPEP 2111.01 (II).
Applicant describes unexpected results (remarks, page 4).
The Examiner responds that evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based (see MPEP 2131.04).
Conclusion
No claims are allowed.
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 Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA ZINGARELLI whose telephone number is (703)756-1799. The examiner can normally be reached M-F 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SANDRA ZINGARELLI/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights