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 invention Group III, claims 5-7, 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, in the reply filed on 01/12/2026 is acknowledged. Claims 8-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claim Status
Claims 1-16 are pending (claim set as filed on 08/08/2023). Claims 8-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/12/2026.
Claims 1-7 are currently under examination and were examined on their merits.
Priority
This application filed on 08/08/2023 claims priority to PCT application no. PCT/JP2022/004972, filed on 02/08/2022, and claims foreign priority to application no. JP2021-018484, filed on 02/08/2021. Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 01/12/2026, 07/14/2025, 10/06/2023, and 08/08/2023 have been received and considered.
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 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a combination of judicial exceptions without significantly more. The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on January 7, 2019 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S.,132 S. Ct. 1289, 101 USPQ2d 1961 (2012)). This guidance indicates that claims must pass an eligibility test to avoid rejection under 35 U.S.C. 101. Under this test, the product must
(a) not be directed to a judicial exception or must (b) contain additional elements that
amount to significantly more than the judicial exception itself.
'Directed to a judicial exception' analysis:
Prong One: Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
Claims 1-2 recite “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” (lines 8-10), wherein ‘homologous protein’ reads on natural protein (see specification, paragraphs [0028], [0040], [0046]), and thus is considered a natural phenomenon.
Claim 3 recites “[a] DNA comprising the nucleotide sequence represented by SEQ ID NO: 1 or 3 or a homologous sequence thereof and encoding the protein according to claim 1” (lines 1-3), wherein ‘homologous sequence thereof’ reads on natural DNA (see specification, paragraphs [0028], [0040], [0046]), and thus is considered a natural phenomenon.
Homologous protein and homologous sequence encoding the protein according to claim 1 are all directed to natural products that do not interact to yield significantly more.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No additional elements are cited that would integrate the judicial exception into a practical application.
'Significantly more' analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because the claims do not include any additional elements other than the judicial exceptions.
Therefore, claims 1-3 are directed to subject matter that is not patent-eligible and are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112(a)
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 1-7 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As stated in MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. Claims 1-7 are directed in part to a genus of proteins having transporting activity for a fucose-containing carbohydrate that are homologous to the polypeptide of SEQ ID NO: 2, and have at least 90% sequence identity to the polypeptide of SEQ ID NO: 2.
In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials”. As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
There is either (a) no structural limitation, or (b) a significant amount of structural variability with respect to the members of the genus of transport proteins required by the claims. While the specification in the instant application discloses the structure of the transport protein of SEQ ID NO: 2, it provides no clue as to the structural elements required in any protein having a transporting activity for a fucose-containing carbohydrate, nor does it teach which structural elements within SEQ ID NO: 2 are required in any protein having a transporting activity for a fucose-containing carbohydrate. Moreover, while the claims require homologues having a transporting activity for a fucose-containing carbohydrate (claim 1), the specification is silent to those structural features in any transport protein, that are associated with these functional properties. No disclosure of a structure/function correlation has been provided which would allow one of skill in the art to recognize which homologues of the polypeptide of SEQ ID NO: 2 having the recited % sequence identity have the desired transport activity for a fucose-containing carbohydrate.
The claims encompass a large genus of proteins which are structurally unrelated or substantially unrelated in structure. A polypeptide having 90% sequence identity with the polypeptide of SEQ ID NO: 2 allows for any combination of 39 amino acid modifications within SEQ ID NO: 2 (39.6 = 0.1x396; SEQ ID NO: 2 has 396 amino acids). The total number of homologs of a polypeptide having a specific number of amino acid substitutions can be calculated from the formula N!x19A/(N-A)!/A!, where N is the length in amino acids of the reference polypeptide and A is the number of allowed substitutions. Thus, the total number of homologs of the polypeptide of SEQ ID NO: 2 having 90% sequence identity to the polypeptide of SEQ ID NO: 2 that result from amino acid substitutions is 396!x1939/(396-39)!/39! or 1.08x10104 homologs. A sufficient written description of a genus of polypeptides may be achieved by a recitation of a representative number of polypeptides defined by their amino acid sequence or a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. However, in the instant case, there is either no recited structural feature which is representative of all the members of the genus of proteins recited, or the recited structural feature, i.e., 90% sequence identity to SEQ ID NO: 2, is not representative of all the members of the genus of protein homologs having transporting activity for a fucose-containing carbohydrate recited, since there is no information as to which are the structural elements within the polypeptide of SEQ ID NO: 2 that are essential for the recited activity, which are the remaining structural elements required in the recited polypeptides in addition to those recited in the claims such that the desired transporting activity is displayed, or a correlation between structure and function which would provide those unknown structural features.
Due to the fact that the specification does not disclose any species of the genus of homologous proteins having transporting activity for a fucose-containing carbohydrate required by the claims, and the lack of description of any additional species by any relevant, identifying structural characteristics or properties, one of skill in the art would not recognize from the disclosure that Applicant was in possession of the claimed invention.
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 6-7 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 6 recites the functional limitation “an enhanced activity of the protein of any one of [ 1] to [3] according to claim 1” is a relative term which renders the claim indefinite since it is unclear which activity of the protein is referred to, and to what the activity of the protein is compared to. Claim 6 further recites the functional limitation “enhanced productivity of the fucose-containing carbohydrate” which renders the claim indefinite since it is unclear to what the productivity of the microorganism is compared to. One of ordinary skill in the art would not be able to determine the metes and bounds of the claim, and thus, could not clearly determine how to avoid infringement of claim 6.
In the interest of compact prosecution, claim 6 is interpreted to the broadest embodiment claimed.
Dependent claim 7 is further rejected since it does not clarify the indefinite language in claim 6.
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.
Claims 1-7 are rejected 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 claims 1-7, please note the elected species ‘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’ under Elections/Restrictions above.
Regarding claims 1-2, pertaining to the protein, Tabata teaches a homologous protein consisting of an amino acid sequence (SEQ ID NO: 17; 396 aa, pages 36-37; paragraph [0040], see claim 1) having 100% identity with the amino acid sequence represented by instant SEQ ID NO: 2, as shown in the alignment below.
Pertaining to the transporting activity for a fucose-containing carbohydrate of the protein (instant claim 1), wherein the fucose-containing carbohydrate is an oligosaccharide (instant claim 2), the transporting activity is an inherent feature of the protein. Tabata teaches the same protein as the instant protein, and as such Tabata’s protein has the same properties, i.e. transporting activity for a fucose-containing carbohydrate, wherein the fucose-containing carbohydrate is an oligosaccharide.
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
Regarding claim 3, pertaining to a DNA, Tabata teaches a DNA (SEQ ID NO: 38; 1591 nt, pages 73-74) comprising a homologous sequence of instant SEQ ID NO:1 (see alignment of instant SEQ ID NO: 38 with Tabata’s SEQ ID NO: 1 below), and encoding the elected homologous protein of claim 1 (see translated amino acid sequence of positions 201-1388 of SEQ ID NO: 38 on pages 73-74; it is noted that the translated amino acid sequence is identical with Tabata’s SEQ ID NO: 17, corresponding to the homologous protein of instant claim 1 discussed above).
GenCore version 6.5.3
Copyright (c) 1993 - 2026 Biocceleration Ltd.
OM nucleic - nucleic search, using sw model
Run on: April 15, 2026, 18:26:17 ; Search time 503 Seconds
(without alignments)
110654.493 Million cell updates/sec
Title: US-18-264-666-1
Perfect score: 1191
Sequence: 1 atgacaacaaacactgtttc..........tcgaagaacagacgcaatag 1191
Scoring table: IDENTITY_NUC
Gapop 10.0 , Gapext 1.0
Searched: 71081971 unique seqs, 23366586982 residues
Total number of hits satisfying chosen parameters: 142163942
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_NA_Main:*
RESULT 2
US-12-594-928A-38
Sequence 38, 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 38
LENGTH: 1591
TYPE: DNA
ORGANISM: Escherichia coli
FEATURE:
NAME/KEY: CDS
LOCATION: (201)..(1388)
Query Match 100.0%; Score 1191; Length 1591;
Best Local Similarity 100.0%;
Matches 1191; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATGACAACAAACACTGTTTCCCGCAAAGTGGCGTGGCTACGGGTCGTTACGCTGGCAGTC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 201 ATGACAACAAACACTGTTTCCCGCAAAGTGGCGTGGCTACGGGTCGTTACGCTGGCAGTC 260
Qy 61 GCCGCCTTCATCTTCAACACCACCGAATTTGTCCCTGTTGGCCTGCTCTCTGACATTGCG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 261 GCCGCCTTCATCTTCAACACCACCGAATTTGTCCCTGTTGGCCTGCTCTCTGACATTGCG 320
Qy 121 CAAAGTTTTCACATGCAAACCGCTCAGGTCGGCATCATGTTGACCATTTACGCATGGGTA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 321 CAAAGTTTTCACATGCAAACCGCTCAGGTCGGCATCATGTTGACCATTTACGCATGGGTA 380
Qy 181 GTAGCGCTAATGTCATTGCCTTTTATGTTAATGACCAGTCAGGTTGAACGGCGCAAATTA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 381 GTAGCGCTAATGTCATTGCCTTTTATGTTAATGACCAGTCAGGTTGAACGGCGCAAATTA 440
Qy 241 CTGATCTGCCTGTTTGTGGTGTTTATTGCCAGCCACGTACTGTCGTTTTTGTCGTGGAGC 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 441 CTGATCTGCCTGTTTGTGGTGTTTATTGCCAGCCACGTACTGTCGTTTTTGTCGTGGAGC 500
Qy 301 TTTACCGTTCTGGTGATCAGTCGCATTGGTGTGGCTTTTGCACATGCGATTTTCTGGTCG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 501 TTTACCGTTCTGGTGATCAGTCGCATTGGTGTGGCTTTTGCACATGCGATTTTCTGGTCG 560
Qy 361 ATTACGGCGTCTCTGGCGATCCGTATGGCTCCGGCCGGGAAGCGAGCACAGGCATTGAGT 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 561 ATTACGGCGTCTCTGGCGATCCGTATGGCTCCGGCCGGGAAGCGAGCACAGGCATTGAGT 620
Qy 421 TTAATTGCCACCGGTACAGCACTGGCGATGGTCTTAGGTTTACCTCTCGGGCGCATTGTG 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 621 TTAATTGCCACCGGTACAGCACTGGCGATGGTCTTAGGTTTACCTCTCGGGCGCATTGTG 680
Qy 481 GGCCAGTATTTCGGTTGGCGAATGACCTTCTTCGCGATTGGTATTGGGGCGCTTATCACC 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 681 GGCCAGTATTTCGGTTGGCGAATGACCTTCTTCGCGATTGGTATTGGGGCGCTTATCACC 740
Qy 541 CTTTTGTGCCTGATTAAGTTACTTCCCTTACTGCCCAGTGAGCATTCCGGTTCACTGAAA 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 741 CTTTTGTGCCTGATTAAGTTACTTCCCTTACTGCCCAGTGAGCATTCCGGTTCACTGAAA 800
Qy 601 AGCCTCCCGCTATTGTTCCGCCGCCCGGCATTGATGAGCATTTATTTGTTAACTGTGGTG 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 801 AGCCTCCCGCTATTGTTCCGCCGCCCGGCATTGATGAGCATTTATTTGTTAACTGTGGTG 860
Qy 661 GTTGTCACCGCCCATTACACGGCATACAGCTATATCGAGCCTTTTGTACAAAACATTGCG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 861 GTTGTCACCGCCCATTACACGGCATACAGCTATATCGAGCCTTTTGTACAAAACATTGCG 920
Qy 721 GGATTCAGCGCCAACTTTGCCACGGCATTACTGTTATTACTCGGTGGTGCGGGCATTATT 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 921 GGATTCAGCGCCAACTTTGCCACGGCATTACTGTTATTACTCGGTGGTGCGGGCATTATT 980
Qy 781 GGCAGCGTGATTTTCGGTAAACTGGGTAATCAGTATGCGTCTGCGTTGGTGAGTACGGCG 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 981 GGCAGCGTGATTTTCGGTAAACTGGGTAATCAGTATGCGTCTGCGTTGGTGAGTACGGCG 1040
Qy 841 ATTGCGCTGTTGCTGGTGTGCCTGGCATTGCTGTTACCTGCGGCGAACAGTGAAATACAC 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1041 ATTGCGCTGTTGCTGGTGTGCCTGGCATTGCTGTTACCTGCGGCGAACAGTGAAATACAC 1100
Qy 901 CTCGGGGTGCTGAGTATTTTCTGGGGGATCGCGATGATGATCATCGGGCTTGGTATGCAG 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1101 CTCGGGGTGCTGAGTATTTTCTGGGGGATCGCGATGATGATCATCGGGCTTGGTATGCAG 1160
Qy 961 GTTAAAGTGCTGGCGCTGGCACCAGATGCTACCGACGTCGCGATGGCGCTATTCTCCGGC 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1161 GTTAAAGTGCTGGCGCTGGCACCAGATGCTACCGACGTCGCGATGGCGCTATTCTCCGGC 1220
Qy 1021 ATATTTAATATTGGAATCGGGGCGGGTGCGTTGGTAGGTAATCAGGTGAGTTTGCACTGG 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1221 ATATTTAATATTGGAATCGGGGCGGGTGCGTTGGTAGGTAATCAGGTGAGTTTGCACTGG 1280
Qy 1081 TCAATGTCGATGATTGGTTATGTGGGCGCGGTGCCTGCTTTTGCCGCGTTAATTTGGTCA 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1281 TCAATGTCGATGATTGGTTATGTGGGCGCGGTGCCTGCTTTTGCCGCGTTAATTTGGTCA 1340
Qy 1141 ATCATTATATTTCGCCGCTGGCCAGTGACACTCGAAGAACAGACGCAATAG 1191
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1341 ATCATTATATTTCGCCGCTGGCCAGTGACACTCGAAGAACAGACGCAATAG 1391
Regarding claim 4, pertaining to a recombinant DNA, Tabata teaches a recombinant DNA comprising the DNA according to claim 3 (see Example 2 including paragraphs [0211]-[0217], [0219]; see SEQ ID NO: 38 in Table 1).
Regarding claim 5, pertaining to a transformant, Tabata teaches a transformant obtained by transforming a host cell with the recombinant DNA according to claim 4 (see Example 2 including paragraph [0218]; see Example 4, including paragraph [0225]).
Regarding claim 6, please note the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the transformant, Tabata teaches that the transformant is a microorganism (paragraphs [0123]-[0124]; see Example 2 including paragraph [0218]; see Example 4, including paragraph [0225]).
Claim 6 further recites the functional limitations “with an enhanced activity of the protein” and “enhanced productivity of the fucose-containing carbohydrate“ of the claimed transformant. As discussed above, Tabata teaches the claimed transformant, and thus teaches the inherent functionalities ‘enhanced activity of the protein’ and ‘enhanced productivity of the fucose-containing carbohydrate’ of said transformant.
Regarding claim 7, please note the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the transformant, Tabata teaches wherein the microorganism is Escherichia coli (paragraphs [0123]-[0124]; see Example 2 including paragraph [0218]; see Example 4, including paragraph [0225]).
Claim 7 further recites the functional limitation “having an ability to produce the fucose-containing carbohydrate”. As discussed above, Tabata teaches the claimed transformant of claim 7, and thus teaches the inherent functionality ‘having an ability to produce the fucose-containing carbohydrate’ of said transformant.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jennewein et al. (US 2018/0305724 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 (see entire document, including abstract).
Regarding claims 1-7, please note the elected species ‘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’ under Elections/Restrictions above.
Regarding claims 1-2, pertaining to the protein, Jennewein teaches YdeA of E. coli MG1655 (“acc. no. AAC74601”; paragraphs [0049], [0129]) consisting of an amino acid sequence having an identity of 100% with the amino acid sequence represented by 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).
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
Pertaining to the transporting activity for a fucose-containing carbohydrate of the protein (instant claim 1), wherein the fucose-containing carbohydrate is an oligosaccharide (instant claim 2), the transporting activity is an inherent feature of the protein. Jennewein teaches the same protein as the instant protein, and as such Jennewein’s protein has the same properties, i.e. transporting activity for a fucose-containing carbohydrate, wherein the fucose-containing carbohydrate is an oligosaccharide pertaining to the fucose-containing carbohydrate.
Regarding claim 3, pertaining to the DNA, Jennewein teaches a DNA (SEQ ID NO: 27; 6684 nt; pages 87-90) comprising a homologous sequence of instant SEQ ID NO:1 (see alignment of instant SEQ ID NO: 1 with Jennewein’s SEQ ID NO: 27 below) and encoding the the elected homologous protein according to claim 1 (see “pINT-ydeA (SeqID27) … ydeA of E. coli MG 1655 integrated into vector pINT” in Table 2 on page 12).
GenCore version 6.5.3
Copyright (c) 1993 - 2026 Biocceleration Ltd.
OM nucleic - nucleic search, using sw model
Run on: April 15, 2026, 18:26:17 ; Search time 503 Seconds
(without alignments)
110654.493 Million cell updates/sec
Title: US-18-264-666-1
Perfect score: 1191
Sequence: 1 atgacaacaaacactgtttc..........tcgaagaacagacgcaatag 1191
Scoring table: IDENTITY_NUC
Gapop 10.0 , Gapext 1.0
Searched: 71081971 unique seqs, 23366586982 residues
Total number of hits satisfying chosen parameters: 142163942
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_NA_Main:*
RESULT 3
US-15-758-653-27
(NOTE: this sequence has 3 duplicates in the database searched.
See complete list at the end of this report)
Sequence 27, US/15758653
Publication No. US20180305724A1
GENERAL INFORMATION
APPLICANT: Jennewein Biotechnologie GmbH
TITLE OF INVENTION: Production of human milk oligosaccharides in microbial hosts with
TITLE OF INVENTION: engineered import/export
FILE REFERENCE: 2827P111EP ; 3000045-002000
CURRENT APPLICATION NUMBER: US/15/758,653
CURRENT FILING DATE: 2018-03-08
PRIOR APPLICATION NUMBER: PCT/EP2016/071420
PRIOR FILING DATE: 2016-09-12
NUMBER OF SEQ ID NOS: 102
SEQ ID NO 27
LENGTH: 6684
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: construct pINT-ydeA
Query Match 100.0%; Score 1191; Length 6684;
Best Local Similarity 100.0%;
Matches 1191; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATGACAACAAACACTGTTTCCCGCAAAGTGGCGTGGCTACGGGTCGTTACGCTGGCAGTC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1490 ATGACAACAAACACTGTTTCCCGCAAAGTGGCGTGGCTACGGGTCGTTACGCTGGCAGTC 1549
Qy 61 GCCGCCTTCATCTTCAACACCACCGAATTTGTCCCTGTTGGCCTGCTCTCTGACATTGCG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1550 GCCGCCTTCATCTTCAACACCACCGAATTTGTCCCTGTTGGCCTGCTCTCTGACATTGCG 1609
Qy 121 CAAAGTTTTCACATGCAAACCGCTCAGGTCGGCATCATGTTGACCATTTACGCATGGGTA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1610 CAAAGTTTTCACATGCAAACCGCTCAGGTCGGCATCATGTTGACCATTTACGCATGGGTA 1669
Qy 181 GTAGCGCTAATGTCATTGCCTTTTATGTTAATGACCAGTCAGGTTGAACGGCGCAAATTA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1670 GTAGCGCTAATGTCATTGCCTTTTATGTTAATGACCAGTCAGGTTGAACGGCGCAAATTA 1729
Qy 241 CTGATCTGCCTGTTTGTGGTGTTTATTGCCAGCCACGTACTGTCGTTTTTGTCGTGGAGC 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1730 CTGATCTGCCTGTTTGTGGTGTTTATTGCCAGCCACGTACTGTCGTTTTTGTCGTGGAGC 1789
Qy 301 TTTACCGTTCTGGTGATCAGTCGCATTGGTGTGGCTTTTGCACATGCGATTTTCTGGTCG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1790 TTTACCGTTCTGGTGATCAGTCGCATTGGTGTGGCTTTTGCACATGCGATTTTCTGGTCG 1849
Qy 361 ATTACGGCGTCTCTGGCGATCCGTATGGCTCCGGCCGGGAAGCGAGCACAGGCATTGAGT 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1850 ATTACGGCGTCTCTGGCGATCCGTATGGCTCCGGCCGGGAAGCGAGCACAGGCATTGAGT 1909
Qy 421 TTAATTGCCACCGGTACAGCACTGGCGATGGTCTTAGGTTTACCTCTCGGGCGCATTGTG 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1910 TTAATTGCCACCGGTACAGCACTGGCGATGGTCTTAGGTTTACCTCTCGGGCGCATTGTG 1969
Qy 481 GGCCAGTATTTCGGTTGGCGAATGACCTTCTTCGCGATTGGTATTGGGGCGCTTATCACC 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1970 GGCCAGTATTTCGGTTGGCGAATGACCTTCTTCGCGATTGGTATTGGGGCGCTTATCACC 2029
Qy 541 CTTTTGTGCCTGATTAAGTTACTTCCCTTACTGCCCAGTGAGCATTCCGGTTCACTGAAA 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2030 CTTTTGTGCCTGATTAAGTTACTTCCCTTACTGCCCAGTGAGCATTCCGGTTCACTGAAA 2089
Qy 601 AGCCTCCCGCTATTGTTCCGCCGCCCGGCATTGATGAGCATTTATTTGTTAACTGTGGTG 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2090 AGCCTCCCGCTATTGTTCCGCCGCCCGGCATTGATGAGCATTTATTTGTTAACTGTGGTG 2149
Qy 661 GTTGTCACCGCCCATTACACGGCATACAGCTATATCGAGCCTTTTGTACAAAACATTGCG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2150 GTTGTCACCGCCCATTACACGGCATACAGCTATATCGAGCCTTTTGTACAAAACATTGCG 2209
Qy 721 GGATTCAGCGCCAACTTTGCCACGGCATTACTGTTATTACTCGGTGGTGCGGGCATTATT 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2210 GGATTCAGCGCCAACTTTGCCACGGCATTACTGTTATTACTCGGTGGTGCGGGCATTATT 2269
Qy 781 GGCAGCGTGATTTTCGGTAAACTGGGTAATCAGTATGCGTCTGCGTTGGTGAGTACGGCG 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2270 GGCAGCGTGATTTTCGGTAAACTGGGTAATCAGTATGCGTCTGCGTTGGTGAGTACGGCG 2329
Qy 841 ATTGCGCTGTTGCTGGTGTGCCTGGCATTGCTGTTACCTGCGGCGAACAGTGAAATACAC 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2330 ATTGCGCTGTTGCTGGTGTGCCTGGCATTGCTGTTACCTGCGGCGAACAGTGAAATACAC 2389
Qy 901 CTCGGGGTGCTGAGTATTTTCTGGGGGATCGCGATGATGATCATCGGGCTTGGTATGCAG 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2390 CTCGGGGTGCTGAGTATTTTCTGGGGGATCGCGATGATGATCATCGGGCTTGGTATGCAG 2449
Qy 961 GTTAAAGTGCTGGCGCTGGCACCAGATGCTACCGACGTCGCGATGGCGCTATTCTCCGGC 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2450 GTTAAAGTGCTGGCGCTGGCACCAGATGCTACCGACGTCGCGATGGCGCTATTCTCCGGC 2509
Qy 1021 ATATTTAATATTGGAATCGGGGCGGGTGCGTTGGTAGGTAATCAGGTGAGTTTGCACTGG 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2510 ATATTTAATATTGGAATCGGGGCGGGTGCGTTGGTAGGTAATCAGGTGAGTTTGCACTGG 2569
Qy 1081 TCAATGTCGATGATTGGTTATGTGGGCGCGGTGCCTGCTTTTGCCGCGTTAATTTGGTCA 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2570 TCAATGTCGATGATTGGTTATGTGGGCGCGGTGCCTGCTTTTGCCGCGTTAATTTGGTCA 2629
Qy 1141 ATCATTATATTTCGCCGCTGGCCAGTGACACTCGAAGAACAGACGCAATAG 1191
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2630 ATCATTATATTTCGCCGCTGGCCAGTGACACTCGAAGAACAGACGCAATAG 2680
Regarding claim 4, pertaining to a recombinant DNA, Jennewein teaches a recombinant DNA comprising the DNA according to claim 3 (paragraphs [0020], [0024], [0026]; see “pINT-ydeA (SeqID27) …. ydeA of E. coli MG1655 integrated into vector pINT” in Table 2).
Regarding claim 5, pertaining to a transformant, Jennewein teaches a transformant obtained by transforming a host cell with the recombinant DNA according to claim 4 (paragraph [0054], paragraph [0127], see Table 2).
Regarding claim 6, please note the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the transformant, Jennnewein teaches the transformant being a microorganism (paragraphs [0054], [0127]).
Claim 6 further recites the functional limitations “an enhanced activity of the protein” and “enhanced productivity of the fucose-containing carbohydrate“ of the claimed transformant. As discussed above, Jennewein teaches the claimed transformant, and thus teaches the inherent functionalities ‘enhanced activity of the protein’ and ‘enhanced productivity of the fucose-containing carbohydrate’ of said transformant.
Regarding claim 7, please note the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the transformant, Jennewein teaches wherein the microorganism is Escherichia coli (paragraphs [0060], [0127]).
Claim 7 further recites the functional limitation “having an ability to produce the fucose-containing carbohydrate” of the transformant. As discussed above, Tabata teaches the claimed transformant of claim 7, and thus teaches the inherent functionality ‘having an ability to produce the fucose-containing carbohydrate’ of said transformant.
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 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/723,065 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘065 and the instant application claim the same protein.
‘065 provides for a homologous protein consisting of an amino acid sequence having an identity of 90% or more with the amino acid sequence represented by SEQ ID NO: 2 wherein SEQ ID NO: 2 taught by ‘065 is identical with instant SEQ ID NO: 2 (see alignment below).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
GenCore version 6.5.2
Copyright (c) 1993 - 2026 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: April 17, 2026, 18:55:17 ; Search time 1 Seconds
(without alignments)
0.157 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: 1 seqs, 396 residues
Total number of hits satisfying chosen parameters: 1
Minimum DB seq length: 0
Maximum DB seq length: inf
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 50 summaries
Database : US-18-723-065-2.fasta:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 1961 100.0 396 1 US-18-723-065-2 METHOD FOR PRODUCI
ALIGNMENTS
RESULT 1
US-18-723-065-2
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 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
Search completed: April 17, 2026, 18:55:17
Job time : 1 secs
Conclusion
No claims are allowed.
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
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