DETAILED ACTION
Application status
In response to the previous Office action, a non-Final rejection (mailed on 12/15/2025), Applicants filed a response and amendment received on 04/14/2026. Said amendment canceled Claims 2-6, amended Claims 1, 7 and 8, and added Claims 10-18 Thus, Claims 1, 7 and 10-18 are at issue and present for examination.
It is noted by the Examiner that Claims 8-9 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b) as being drawn to a non-elected invention in the previous Office actions, a non-Final rejection (mailed on 12/15/2025).
Claim Objections - MAINTAINED
Claim 1 is objected to because of the following informalities:
Claim 1 is objected to because the recitation of “shown in” can be substantially improved grammar. The Examiner suggests replacing the noted phrase with “of”.
Although Applicants note that Applicants’ have amended claim 1 as suggested by the Examiner, claim 1 remains to recite “shown in” language throughout. Therefore, the instant objection is maintained.
Appropriate correction is required.
Claim Rejections - 35 USC § 101 - MAINTAINTED
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.
The previous rejection of Claim 1 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon) without significantly more, is maintained.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of the following steps:
(1) whether the claim is directed to one of the four categories recited in §101 (process, machine, manufacture or composition of matter);
(Revised 2A - Prong 1) do the claims recite an abstract idea (mathematical concepts, mental processes or method of organizing human activity), law of nature or natural phenomenon;
(Revised 2A - Prong 2) do the claims recite additional elements that integrate the judicial exception into a practical application; and
(2B) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. (See 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG))
Question 1: Yes; the claims are directed to a composition of matter.
Question 2A – Prong 1: Yes, the claims recite a natural phenomenon, namely, a naturally occurring polypeptide, and any excipient which includes water.
Question 2A – Prong 2: No, the claims do not recite anything additional which integrate the naturally occurring polypeptide into a practical application. It is noted that the addition of an excipient which includes water to naturally glutaminases, i.e., SEQ ID NOs: 1 and 2, derived from Chryseobacterium sp. strain 57594 and strain 61798, does not change the naturally occurring enzymes which are naturally found in the cytoplasm (water) of Chryseobacterium. There is nothing in the claims and specification which differentiates these naturally occurring enzymes in terms of structure and/or function from the naturally occurring protein-glutaminases found in Chryseobacterium sp. strain 57594 and strain 61798 just by adding an excipient which includes water. Thus, there is ultimately nothing in the claims which amounts to significantly more or significantly different from those protein-glutaminases found in nature. It is noted by the Examiner that even when there are some insertions, deletions and substitutions, especially with respect to parts (b) and (c) of claim 1, the end result is naturally occurring enzymes. For instance, the sequence search results of SEQ ID NOs: 1 and 2 disclose that a naturally occurring protein-glutaminase having 99.2% or 97.9% sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2, respectively as shown below.
(copied/pasted from Sequence Search Result 20251201_132705_us-18-037-934-1.rup, available in SCV)
RESULT 1
A0A2S9CPY3_CHRCI
ID A0A2S9CPY3_CHRCI Unreviewed; 319 AA.
AC A0A2S9CPY3;
DT 18-JUL-2018, integrated into UniProtKB/TrEMBL.
DT 18-JUL-2018, sequence version 1.
DT 08-OCT-2025, entry version 14.
DE RecName: Full=Protein glutaminase domain-containing protein {ECO:0000259|Pfam:PF18626};
GN ORFNames=CQ022_17855 {ECO:0000313|EMBL:PRB82551.1}, CQ033_16750
GN {ECO:0000313|EMBL:PRB88926.1};
OS Chryseobacterium culicis.
OC Bacteria; Pseudomonadati; Bacteroidota; Flavobacteriia; Flavobacteriales;
OC Weeksellaceae; Chryseobacterium group; Chryseobacterium.
OX NCBI_TaxID=680127 {ECO:0000313|EMBL:PRB82551.1, ECO:0000313|Proteomes:UP000238534};
RN [1] {ECO:0000313|Proteomes:UP000238325, ECO:0000313|Proteomes:UP000238534}
RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA].
RC STRAIN=MYb25 {ECO:0000313|EMBL:PRB82551.1,
RC ECO:0000313|Proteomes:UP000238534}, and MYb44
RC {ECO:0000313|EMBL:PRB88926.1, ECO:0000313|Proteomes:UP000238325};
RA Zimmermann J., Obeng N., Yang W., Obeng O., Kissoyan K., Pees B.,
RA Dirksen P., Hoppner M., Franke A., Rosenstiel P., Leippe M., Dierking K.,
RA Kaleta C., Schulenburg H.;
RT "Genomic, metabolic, and phenotypic characteristics of bacterial isolates
RT from the natural microbiome of the model nematode Caenorhabditis elegans.";
RL Submitted (SEP-2017) to the EMBL/GenBank/DDBJ databases.
CC -!- CAUTION: The sequence shown here is derived from an EMBL/GenBank/DDBJ
CC whole genome shotgun (WGS) entry which is preliminary data.
CC {ECO:0000313|EMBL:PRB82551.1}.
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DR EMBL; PCPP01000003; PRB82551.1; -; Genomic_DNA.
DR EMBL; PCPH01000004; PRB88926.1; -; Genomic_DNA.
DR RefSeq; WP_105683660.1; NZ_JBBGZD010000003.1.
DR AlphaFoldDB; A0A2S9CPY3; -.
DR OrthoDB; 8417456at2; -.
DR Proteomes; UP000238325; Unassembled WGS sequence.
DR Proteomes; UP000238534; Unassembled WGS sequence.
DR Gene3D; 2.40.50.340; -; 1.
DR Gene3D; 3.10.620.30; -; 1.
DR InterPro; IPR041325; Gln_deamidase_2.
DR NCBIfam; NF040782; PG_glutam_Chrys; 1.
DR Pfam; PF18626; Gln_deamidase_2; 1.
PE 4: Predicted;
KW Reference proteome {ECO:0000313|Proteomes:UP000238325};
KW Signal {ECO:0000256|SAM:SignalP}.
FT SIGNAL 1..21
FT /evidence="ECO:0000256|SAM:SignalP"
FT CHAIN 22..319
FT /note="Protein glutaminase domain-containing protein"
FT /evidence="ECO:0000256|SAM:SignalP"
FT /id="PRO_5015407182"
FT DOMAIN 146..254
FT /note="Protein glutaminase"
FT /evidence="ECO:0000259|Pfam:PF18626"
SQ SEQUENCE 319 AA; 34739 MW; 939C596E4AFEE2CD CRC64;
Query Match 99.2%; Score 1651; Length 319;
Best Local Similarity 99.1%;
Matches 316; Conservative 1; Mismatches 2; Indels 0; Gaps 0;
Qy 1 MKKFLLSMMVFVTMLSFNACSDSAANQDPNLVAKESNEIAMKDFGKTVPVGIEKEEGKFK 60
||||||||||||||||||||||| ||||||||||||||||||||||||||||||||||||
Db 1 MKKFLLSMMVFVTMLSFNACSDSGANQDPNLVAKESNEIAMKDFGKTVPVGIEKEEGKFK 60
Qy 61 VSFMVSAQPYHIKDSKENAGYISMIRQAVENETPVHIFLKTNTTEIAKVDKPTDDDIRYF 120
||||||||||||||||||||||||||||||||||||||||||| ||||||||||||||||
Db 61 VSFMVSAQPYHIKDSKENAGYISMIRQAVENETPVHIFLKTNTNEIAKVDKPTDDDIRYF 120
Qy 121 KSVFNKEERGDSKKAVSVIPNLATLNSLFTQIKNQACGTSTASSPCITFRYPVDGCYARA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KSVFNKEERGDSKKAVSVIPNLATLNSLFTQIKNQACGTSTASSPCITFRYPVDGCYARA 180
Qy 181 HKMRQILLNAGYDCEKQFVYGNLRASTGTCCVSWVYHVAILVSFKNASGIVEKRIIDPSL 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 HKMRQILLNAGYDCEKQFVYGNLRASTGTCCVSWVYHVAILVSFKNASGIVEKRIIDPSL 240
Qy 241 FSSGPVTDAAWRAACTNTSCGSASVSSYANTAGNVYYRSPSGSLLYDNNYVNTNCVLNIF 300
|||||||||||||||||||||||||||:||||||||||||||||||||||||||||||||
Db 241 FSSGPVTDAAWRAACTNTSCGSASVSSFANTAGNVYYRSPSGSLLYDNNYVNTNCVLNIF 300
Qy 301 SSLSGCSPSPAPSVASCGF 319
|||||||||||||||||||
Db 301 SSLSGCSPSPAPSVASCGF 319
(copied/pasted from Sequence Search Result 20251201_132705_us-18-037-934-2.rup, available in SCV)
RESULT 1
A0ABX9X9X8_9FLAO
ID A0ABX9X9X8_9FLAO Unreviewed; 319 AA.
AC A0ABX9X9X8;
DT 08-OCT-2025, integrated into UniProtKB/TrEMBL.
DT 08-OCT-2025, sequence version 1.
DT 08-OCT-2025, entry version 1.
DE SubName: Full=Uncharacterized protein {ECO:0000313|EMBL:ROH95086.1};
GN ORFNames=EGI15_04285 {ECO:0000313|EMBL:ROH95086.1};
OS Chryseobacterium cucumeris.
OC Bacteria; Pseudomonadati; Bacteroidota; Flavobacteriia; Flavobacteriales;
OC Weeksellaceae; Chryseobacterium group; Chryseobacterium.
OX NCBI_TaxID=1813611 {ECO:0000313|EMBL:ROH95086.1, ECO:0000313|Proteomes:UP000281899};
RN [1] {ECO:0000313|EMBL:ROH95086.1, ECO:0000313|Proteomes:UP000281899}
RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA].
RC STRAIN=G0235 {ECO:0000313|EMBL:ROH95086.1,
RC ECO:0000313|Proteomes:UP000281899};
RA Nicholson A.C., Gulvik C.A., Whitney A.M., Humrighouse B.W., Bell M.,
RA Holmes B., Steigerwalt A., Villarma A., Sheth M., Batra D., Pryor J.,
RA Bernardet J.-F., Hugo C., Kampfer P., Newman J., Mcquiston J.R.;
RT "Proposal to divide the Flavobacteriaceae and reorganize its genera based
RT on Amino Acid Identity values calculated from whole genome sequences.";
RL Submitted (NOV-2018) to the EMBL/GenBank/DDBJ databases.
CC -!- CAUTION: The sequence shown here is derived from an EMBL/GenBank/DDBJ
CC whole genome shotgun (WGS) entry which is preliminary data.
CC {ECO:0000313|EMBL:ROH95086.1}.
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DR EMBL; RJTW01000003; ROH95086.1; -; Genomic_DNA.
DR Proteomes; UP000281899; Unassembled WGS sequence.
PE 4: Predicted;
KW Reference proteome {ECO:0000313|Proteomes:UP000281899}.
SQ SEQUENCE 319 AA; 34587 MW; A4D2CB204924F21F CRC64;
Query Match 97.9%; Score 1618; Length 319;
Best Local Similarity 97.2%;
Matches 310; Conservative 7; Mismatches 2; Indels 0; Gaps 0;
Qy 1 MKKFLLSMMVFVTVLSFNSCSDSSANQDPNLVAKESNEIAMKDFGKTVPVGIEKEDGKFK 60
|||||||||||||||| ||||||:||||||||||||||||||||||||||||||||||||
Db 1 MKKFLLSMMVFVTVLSVNSCSDSAANQDPNLVAKESNEIAMKDFGKTVPVGIEKEDGKFK 60
Qy 61 VSFIVSAQPYQIKDTKENAGYISMIKEAVENETPVQVFLKANSNEIAKVDKATADDIRYF 120
|||:||||||||||||||||:||||||||||||||||||| ||||||||:||||||||||
Db 61 VSFMVSAQPYQIKDTKENAGFISMIKEAVENETPVQVFLKVNSNEIAKVEKATADDIRYF 120
Qy 121 KSVFNKEERGDSRKAVSVIPNLATLNSLFTQIKNQACGTSTASSPCITFRYPVDGCYARA 180
|:||||||||||:|||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KTVFNKEERGDSKKAVSVIPNLATLNSLFTQIKNQACGTSTASSPCITFRYPVDGCYARA 180
Qy 181 HKMRQILLNAGYDCEKQFVYGNLRASTGTCCVSWVYHVAILVSFKNASGIVEKRIIDPSL 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 HKMRQILLNAGYDCEKQFVYGNLRASTGTCCVSWVYHVAILVSFKNASGIVEKRIIDPSL 240
Qy 241 FSSGPVTDTAWRAACTNTSCGSASVSSYANTAGNVYYRSPSGSLLYDNNYVNTNCVLNIF 300
||||||||:|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 FSSGPVTDSAWRAACTNTSCGSASVSSYANTAGNVYYRSPSGSLLYDNNYVNTNCVLNIF 300
Qy 301 SSLSGCSPSPAPSVASCGF 319
|||||||||||||||||||
Db 301 SSLSGCSPSPAPSVASCGF 319
Question 2B: As noted in answering that of 2A – Prong 2 above, there is nothing in the claims which amounts to significantly more in terms of structure and/or function and the claims read on naturally occurring protein-glutaminases with water (an example of excipient). Thus, the claims are drawn to a judicial exception, namely, a naturally occurring product, and the instant rejection is maintained.
Applicants’ Arguments / Examiner’s Explanation:
Although Applicants argue that adding a limitation “(b) an additive selected from the group consisting of another enzyme, an excipient, a buffer, a suspending agent, a stabilizer, a preservative, an antiseptic and physiological saline” to claim 1 makes it patent-eligible, the Examiner explained above that a water is an excipient which the naturally occurring enzymes are naturally found in, i.e. cytoplasm of Chryseobacterium. Therefore, claim 1 remains to be patent ineligible under 35 U.S.C. 101.
Claim Rejections - 35 U.S.C. § 112 - WITHDRAWN
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 previous rejection of Claim under 35 U.S.C. § 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention, is withdrawn by virtue of Applicants’ amendment.
The following is a quotation 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 previous rejection of Claims 1 and 6-7 under 35 U.S.C. § 112(a), written description, as failing to comply with the written description requirement, is withdrawn by virtue of Applicants’ amendment.
Claim Rejections - 35 U.S.C. § 102 - WITHDRAWN
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.
The previous rejection of Claims 1 and 6-7 under 35 U.S.C. 102(a)(1) as being anticipated by Zimmermann et al. (UniProt accession no. A0A2S9CPY3, see sequence search result 1 from 20251201_132705_us-18-037-934-1.rup, available in SCV, which has been copied/pasted below for Applicants’ convenience), is withdrawn because Zimmermann et al. do not teach the newly added limitation of claim 1: “(b) an additive selected from the group consisting of another enzyme, an excipient, a buffer, a suspending agent, a stabilizer, a preservative, an antiseptic and physiological saline”.
The previous rejection of Claims 1 and 6-7 under 35 U.S.C. 102(a)(1) as being anticipated by de Groot (UniProt accession no. A0A1H6I911, see sequence search result 3 copied/pasted from Sequence Search Result 20251201_132705_us-18-037-934-2.rup, available in SCV), is withdrawn because de Groot do not teach the newly added limitation of claim 1: “(b) an additive selected from the group consisting of another enzyme, an excipient, a buffer, a suspending agent, a stabilizer, a preservative, an antiseptic and physiological saline”.
Claim Rejections - 35 USC § 103 – New Grounds of Rejection Necessitated by Applicants’ Amendment to Claims
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 7 and 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Zimmermann et al. (UniProt accession no. A0A2S9CPY3, see sequence search result 1 from 20251201_132705_us-18-037-934-1.rup, available in SCV, which has been copied/pasted below for Applicants’ convenience) and de Groot (UniProt accession no. A0A1H6I911, see sequence search result 3 copied/pasted from Sequence Search Result 20251201_132705_us-18-037-934-2.rup, available in SCV) in
view of Jones et al. (US Patent No. 12227565 with an effective filing date of 06/20/2018).
The instant claims are drawn to an enzyme preparation comprising:
a protein-glutaminase polypeptide of any one of the following (1) to (3):
a polypeptide having the amino acid sequence shown in SEQ ID NO: 1 or 2; and
a polypeptide having an amino acid sequence obtained by substituting, adding, inserting, or deleting 1-50 amino acid residues in the amino acid sequence shown in SEQ ID NO: 1 or 2; and
a polypeptide having an amino acid sequence having at least 85% sequence identity to the amino acid sequence shown in SEQ ID NO: 1 or 2; and
an additive selected from the group consisting of another enzyme, an excipient, a buffer, a suspending agent, a stabilizer, a preservative, an antiseptic and physiological saline.
Zimmermann et al. teach a polypeptide having 99.2% sequence identity to Applicants’ SEQ ID NO: 1 (see below sequence search result).
RESULT 1
A0A2S9CPY3_CHRCI
ID A0A2S9CPY3_CHRCI Unreviewed; 319 AA.
AC A0A2S9CPY3;
DT 18-JUL-2018, integrated into UniProtKB/TrEMBL.
DT 18-JUL-2018, sequence version 1.
DT 08-OCT-2025, entry version 14.
DE RecName: Full=Protein glutaminase domain-containing protein {ECO:0000259|Pfam:PF18626};
GN ORFNames=CQ022_17855 {ECO:0000313|EMBL:PRB82551.1}, CQ033_16750
GN {ECO:0000313|EMBL:PRB88926.1};
OS Chryseobacterium culicis.
OC Bacteria; Pseudomonadati; Bacteroidota; Flavobacteriia; Flavobacteriales;
OC Weeksellaceae; Chryseobacterium group; Chryseobacterium.
OX NCBI_TaxID=680127 {ECO:0000313|EMBL:PRB82551.1, ECO:0000313|Proteomes:UP000238534};
RN [1] {ECO:0000313|Proteomes:UP000238325, ECO:0000313|Proteomes:UP000238534}
RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA].
RC STRAIN=MYb25 {ECO:0000313|EMBL:PRB82551.1,
RC ECO:0000313|Proteomes:UP000238534}, and MYb44
RC {ECO:0000313|EMBL:PRB88926.1, ECO:0000313|Proteomes:UP000238325};
RA Zimmermann J., Obeng N., Yang W., Obeng O., Kissoyan K., Pees B.,
RA Dirksen P., Hoppner M., Franke A., Rosenstiel P., Leippe M., Dierking K.,
RA Kaleta C., Schulenburg H.;
RT "Genomic, metabolic, and phenotypic characteristics of bacterial isolates
RT from the natural microbiome of the model nematode Caenorhabditis elegans.";
RL Submitted (SEP-2017) to the EMBL/GenBank/DDBJ databases.
CC -!- CAUTION: The sequence shown here is derived from an EMBL/GenBank/DDBJ
CC whole genome shotgun (WGS) entry which is preliminary data.
CC {ECO:0000313|EMBL:PRB82551.1}.
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DR EMBL; PCPP01000003; PRB82551.1; -; Genomic_DNA.
DR EMBL; PCPH01000004; PRB88926.1; -; Genomic_DNA.
DR RefSeq; WP_105683660.1; NZ_JBBGZD010000003.1.
DR AlphaFoldDB; A0A2S9CPY3; -.
DR OrthoDB; 8417456at2; -.
DR Proteomes; UP000238325; Unassembled WGS sequence.
DR Proteomes; UP000238534; Unassembled WGS sequence.
DR Gene3D; 2.40.50.340; -; 1.
DR Gene3D; 3.10.620.30; -; 1.
DR InterPro; IPR041325; Gln_deamidase_2.
DR NCBIfam; NF040782; PG_glutam_Chrys; 1.
DR Pfam; PF18626; Gln_deamidase_2; 1.
PE 4: Predicted;
KW Reference proteome {ECO:0000313|Proteomes:UP000238325};
KW Signal {ECO:0000256|SAM:SignalP}.
FT SIGNAL 1..21
FT /evidence="ECO:0000256|SAM:SignalP"
FT CHAIN 22..319
FT /note="Protein glutaminase domain-containing protein"
FT /evidence="ECO:0000256|SAM:SignalP"
FT /id="PRO_5015407182"
FT DOMAIN 146..254
FT /note="Protein glutaminase"
FT /evidence="ECO:0000259|Pfam:PF18626"
SQ SEQUENCE 319 AA; 34739 MW; 939C596E4AFEE2CD CRC64;
Query Match 99.2%; Score 1651; Length 319;
Best Local Similarity 99.1%;
Matches 316; Conservative 1; Mismatches 2; Indels 0; Gaps 0;
Qy 1 MKKFLLSMMVFVTMLSFNACSDSAANQDPNLVAKESNEIAMKDFGKTVPVGIEKEEGKFK 60
||||||||||||||||||||||| ||||||||||||||||||||||||||||||||||||
Db 1 MKKFLLSMMVFVTMLSFNACSDSGANQDPNLVAKESNEIAMKDFGKTVPVGIEKEEGKFK 60
Qy 61 VSFMVSAQPYHIKDSKENAGYISMIRQAVENETPVHIFLKTNTTEIAKVDKPTDDDIRYF 120
||||||||||||||||||||||||||||||||||||||||||| ||||||||||||||||
Db 61 VSFMVSAQPYHIKDSKENAGYISMIRQAVENETPVHIFLKTNTNEIAKVDKPTDDDIRYF 120
Qy 121 KSVFNKEERGDSKKAVSVIPNLATLNSLFTQIKNQACGTSTASSPCITFRYPVDGCYARA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KSVFNKEERGDSKKAVSVIPNLATLNSLFTQIKNQACGTSTASSPCITFRYPVDGCYARA 180
Qy 181 HKMRQILLNAGYDCEKQFVYGNLRASTGTCCVSWVYHVAILVSFKNASGIVEKRIIDPSL 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 HKMRQILLNAGYDCEKQFVYGNLRASTGTCCVSWVYHVAILVSFKNASGIVEKRIIDPSL 240
Qy 241 FSSGPVTDAAWRAACTNTSCGSASVSSYANTAGNVYYRSPSGSLLYDNNYVNTNCVLNIF 300
|||||||||||||||||||||||||||:||||||||||||||||||||||||||||||||
Db 241 FSSGPVTDAAWRAACTNTSCGSASVSSFANTAGNVYYRSPSGSLLYDNNYVNTNCVLNIF 300
Qy 301 SSLSGCSPSPAPSVASCGF 319
|||||||||||||||||||
Db 301 SSLSGCSPSPAPSVASCGF 319
de Groot teaches a polypeptide having 96.3% sequence identity to Applicants’ SEQ ID NO: 2 (see below sequence search result).
RESULT 3
A0A1H6I911_CHRCI
ID A0A1H6I911_CHRCI Unreviewed; 312 AA.
AC A0A1H6I911;
DT 22-NOV-2017, integrated into UniProtKB/TrEMBL.
DT 22-NOV-2017, sequence version 1.
DT 02-APR-2025, entry version 20.
DE RecName: Full=Protein glutaminase domain-containing protein {ECO:0000259|Pfam:PF18626};
GN ORFNames=SAMN05421593_4276 {ECO:0000313|EMBL:SEH45085.1};
OS Chryseobacterium culicis.
OC Bacteria; Pseudomonadati; Bacteroidota; Flavobacteriia; Flavobacteriales;
OC Weeksellaceae; Chryseobacterium group; Chryseobacterium.
OX NCBI_TaxID=680127 {ECO:0000313|EMBL:SEH45085.1, ECO:0000313|Proteomes:UP000198561};
RN [1] {ECO:0000313|EMBL:SEH45085.1, ECO:0000313|Proteomes:UP000198561}
RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA].
RC STRAIN=DSM 23031 {ECO:0000313|EMBL:SEH45085.1,
RC ECO:0000313|Proteomes:UP000198561};
RA de Groot N.N.;
RL Submitted (OCT-2016) to the EMBL/GenBank/DDBJ databases.
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DR EMBL; FNWQ01000007; SEH45085.1; -; Genomic_DNA.
DR AlphaFoldDB; A0A1H6I911; -.
DR Proteomes; UP000198561; Unassembled WGS sequence.
DR Gene3D; 2.40.50.340; -; 1.
DR Gene3D; 3.10.620.30; -; 1.
DR InterPro; IPR041325; Gln_deamidase_2.
DR NCBIfam; NF040782; PG_glutam_Chrys; 1.
DR Pfam; PF18626; Gln_deamidase_2; 1.
PE 4: Predicted;
FT DOMAIN 139..247
FT /note="Protein glutaminase"
FT /evidence="ECO:0000259|Pfam:PF18626"
SQ SEQUENCE 312 AA; 33816 MW; 8F837575DC5F7DE4 CRC64;
Query Match 96.3%; Score 1592; Length 312;
Best Local Similarity 96.8%;
Matches 302; Conservative 8; Mismatches 2; Indels 0; Gaps 0;
Qy 8 MMVFVTVLSFNSCSDSSANQDPNLVAKESNEIAMKDFGKTVPVGIEKEDGKFKVSFIVSA 67
||||||:||||:|||||||||||||||||||:||||||||||||||||||||:|||:|||
Db 1 MMVFVTMLSFNACSDSSANQDPNLVAKESNEVAMKDFGKTVPVGIEKEDGKFRVSFMVSA 60
Qy 68 QPYQIKDTKENAGYISMIKEAVENETPVQVFLKANSNEIAKVDKATADDIRYFKSVFNKE 127
||| :||||||||||||||||||||||||:||||||||||||||||||||||||||||||
Db 61 QPYHLKDTKENAGYISMIKEAVENETPVQIFLKANSNEIAKVDKATADDIRYFKSVFNKE 120
Qy 128 ERGDSRKAVSVIPNLATLNSLFTQIKNQACGTSTASSPCITFRYPVDGCYARAHKMRQIL 187
|||||:||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ERGDSKKAVSVIPNLATLNSLFTQIKNQACGTSTASSPCITFRYPVDGCYARAHKMRQIL 180
Qy 188 LNAGYDCEKQFVYGNLRASTGTCCVSWVYHVAILVSFKNASGIVEKRIIDPSLFSSGPVT 247
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 LNAGYDCEKQFVYGNLRASTGTCCVSWVYHVAILVSFKNASGIVEKRIIDPSLFSSGPVT 240
Qy 248 DTAWRAACTNTSCGSASVSSYANTAGNVYYRSPSGSLLYDNNYVNTNCVLNIFSSLSGCS 307
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 DTAWRAACTNTSCGSASVSSYANTAGNVYYRSPSGSLLYDNNYVNTNCVLNIFSSLSGCS 300
Qy 308 PSPAPSVASCGF 319
||||||| ||||
Db 301 PSPAPSVGSCGF 312
Zimmermann et al. and de Groot do not teach “an additive selected from the group consisting of another enzyme, an excipient, a buffer, a suspending agent, a stabilizer, a preservative, an antiseptic and physiological saline”.
Jones et al. teach that all of the additives recited in claims 1 and 10-18 selected from the group consisting of another enzyme, i.e. amylase (claim 10), an excipient, i.e. starch, dextrin (claim 11), a buffer, i.e. phosphate buffer (claim 12), a suspending agent, a stabilizer, i.e. propylene glycol (claim 13), a preservative, i.e. benzoate or sorbate as alkali metal salt, a potassium or sodium salt (claims 14-17), an antiseptic, i.e. ethanol (claim 18) and physiological saline as part of a pharmaceutical composition or drug formulation (see the entire patent).
It would have been obvious to a person of ordinary skill in the art (POSITA) prior to the effective filing date of the instant application to make and use the composition comprising the glutaminases taught by Zimmermann et al. and de Groot with an additive taught by Jones et al. A POSITA would have been motivated to make and use such composition because such additives are routinely added in pharmaceutical compositions or drug formulations as taught by Jones et al. for the purposes of enhancing the shelf life and/or effectiveness of the agent (see the entire patent). A POSITA would have had a reasonable expectation of success to make and use such composition because all of the required biochemical reagents and techniques were readily available and rampantly used as evidenced by Zimmermann et al., de Groot and Jones et al. prior to the filing of the instant application.
For the reasons provided herein, the invention as claimed is prima facie obvious over the combined teachings of the prior art.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 7 and 10-18 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5 of copending Application No. 18/562750.
A timely filed terminal disclaimer in compliance with 37 C.F.R. § 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 C.F.R. § 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 C.F.R. § 3.73(b).
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows:
Claim 1 of the instant application:
An enzyme preparation comprising:
a protein-glutaminase polypeptide of any one of the following (1) to (3):
a polypeptide having the amino acid sequence shown in SEQ ID NO: 1 or 2; and
a polypeptide having an amino acid sequence obtained by substituting, adding, inserting, or deleting 1-50 amino acid residues in the amino acid sequence shown in SEQ ID NO: 1 or 2; and
a polypeptide having an amino acid sequence having at least 85% sequence identity to the amino acid sequence shown in SEQ ID NO: 1 or 2; and
an additive selected from the group consisting of another enzyme, an excipient, a buffer, a suspending agent, a stabilizer, a preservative, an antiseptic and physiological saline.
Claims 1-3 of ‘750 application:
Claims 1. A method for producing a processed oat-food or drink product or food ingredient, the method comprising the step for treating an oat-food or drink product or food ingredient that has not been subjected to heat treatment, with a protein deamidase under a temperature condition of 65 to 75° C.
Claim 2. The method according to claim 1, wherein the protein deamidase is a protein glutaminase derived from Chryseobacterium proteolyticum.
Claim 3. The method according to claim 1, wherein the protein deamidase is a protein glutaminase comprising a polypeptide described in any of (1) to (3) below: (1) a polypeptide having an amino acid sequence set forth in SEQ ID NO: 1 or 2; (2) a polypeptide in which one or several amino acid residues are substituted, added, inserted, or deleted in the amino acid sequence set forth in SEQ ID NO: 1 or 2 and that exhibits heat resistance equivalent to heat resistance of a polypeptide having the amino acid sequence set forth in SEQ ID NO: 1 or 2; and (3) a polypeptide having a sequence identity of 76% or more to the amino acid sequence set forth in SEQ ID NO: 1 or 2 and exhibiting heat resistance equivalent to heat resistance of a polypeptide having the amino acid sequence set forth in SEQ ID NO: 1 or 2.
Thus, the claims in their broadest differ because the instant claims are drawn to a composition comprising glutaminases, and the claims of ‘750 application are drawn to methods of using the same glutaminases of SEQ ID NO: 1 or 2 having 100% sequence identity as shown below (Qy is SEQ ID NO: 1 and 2 from the instant application and Db is SEQ ID NO: 1 and 2 from ‘750 application). The instant specification further disclose that said glutaminases can be use in methods for production of food and drink with optimal temperature between 60 to 70°C (see para [0076]-[0079]). As such, it would have been obvious for a POSITA to use the claimed invention in the methods claimed in ‘750 application. A POSITA would have been motivated to use the claimed invention in in methods for production of food and drink with optimal temperature between 60 to 70°C as this was already disclosed in the instant specification under para [0076]-[0079]. A POSITA would have had a reasonable expectation of success to make and use such composition because all of the required biochemical reagents, additives and techniques were readily available as the instant application discloses.
GenCore version 6.5.2
Copyright (c) 1993 - 2026 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: May 20, 2026, 15:27:29 ; Search time 1 Seconds
(without alignments)
0.102 Million cell updates/sec
Title: US-18-037-934-1
Perfect score: 1664
Sequence: 1 MKKFLLSMMVFVTMLSFNAC..........FSSLSGCSPSPAPSVASCGF 319
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 319 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-18-562-750-1.fasta:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 1664 100.0 319 1 US-18-562-750-1 Method for manufac
ALIGNMENTS
RESULT 1
US-18-562-750-1
Query Match 100.0%; Score 1664; DB 1; Length 319;
Best Local Similarity 100.0%;
Matches 319; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKKFLLSMMVFVTMLSFNACSDSAANQDPNLVAKESNEIAMKDFGKTVPVGIEKEEGKFK 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKKFLLSMMVFVTMLSFNACSDSAANQDPNLVAKESNEIAMKDFGKTVPVGIEKEEGKFK 60
Qy 61 VSFMVSAQPYHIKDSKENAGYISMIRQAVENETPVHIFLKTNTTEIAKVDKPTDDDIRYF 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VSFMVSAQPYHIKDSKENAGYISMIRQAVENETPVHIFLKTNTTEIAKVDKPTDDDIRYF 120
Qy 121 KSVFNKEERGDSKKAVSVIPNLATLNSLFTQIKNQACGTSTASSPCITFRYPVDGCYARA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KSVFNKEERGDSKKAVSVIPNLATLNSLFTQIKNQACGTSTASSPCITFRYPVDGCYARA 180
Qy 181 HKMRQILLNAGYDCEKQFVYGNLRASTGTCCVSWVYHVAILVSFKNASGIVEKRIIDPSL 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 HKMRQILLNAGYDCEKQFVYGNLRASTGTCCVSWVYHVAILVSFKNASGIVEKRIIDPSL 240
Qy 241 FSSGPVTDAAWRAACTNTSCGSASVSSYANTAGNVYYRSPSGSLLYDNNYVNTNCVLNIF 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 FSSGPVTDAAWRAACTNTSCGSASVSSYANTAGNVYYRSPSGSLLYDNNYVNTNCVLNIF 300
Qy 301 SSLSGCSPSPAPSVASCGF 319
|||||||||||||||||||
Db 301 SSLSGCSPSPAPSVASCGF 319
GenCore version 6.5.2
Copyright (c) 1993 - 2026 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: May 20, 2026, 15:35:00 ; Search time 1 Seconds
(without alignments)
0.102 Million cell updates/sec
Title: US-18-037-934-2
Perfect score: 1653
Sequence: 1 MKKFLLSMMVFVTVLSFNSC..........FSSLSGCSPSPAPSVASCGF 319
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 319 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-18-562-750-2.fasta:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 1653 100.0 319 1 US-18-562-750-2 Method for manufac
ALIGNMENTS
RESULT 1
US-18-562-750-2
Query Match 100.0%; Score 1653; DB 1; Length 319;
Best Local Similarity 100.0%;
Matches 319; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKKFLLSMMVFVTVLSFNSCSDSSANQDPNLVAKESNEIAMKDFGKTVPVGIEKEDGKFK 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKKFLLSMMVFVTVLSFNSCSDSSANQDPNLVAKESNEIAMKDFGKTVPVGIEKEDGKFK 60
Qy 61 VSFIVSAQPYQIKDTKENAGYISMIKEAVENETPVQVFLKANSNEIAKVDKATADDIRYF 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VSFIVSAQPYQIKDTKENAGYISMIKEAVENETPVQVFLKANSNEIAKVDKATADDIRYF 120
Qy 121 KSVFNKEERGDSRKAVSVIPNLATLNSLFTQIKNQACGTSTASSPCITFRYPVDGCYARA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KSVFNKEERGDSRKAVSVIPNLATLNSLFTQIKNQACGTSTASSPCITFRYPVDGCYARA 180
Qy 181 HKMRQILLNAGYDCEKQFVYGNLRASTGTCCVSWVYHVAILVSFKNASGIVEKRIIDPSL 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 HKMRQILLNAGYDCEKQFVYGNLRASTGTCCVSWVYHVAILVSFKNASGIVEKRIIDPSL 240
Qy 241 FSSGPVTDTAWRAACTNTSCGSASVSSYANTAGNVYYRSPSGSLLYDNNYVNTNCVLNIF 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 FSSGPVTDTAWRAACTNTSCGSASVSSYANTAGNVYYRSPSGSLLYDNNYVNTNCVLNIF 300
Qy 301 SSLSGCSPSPAPSVASCGF 319
|||||||||||||||||||
Db 301 SSLSGCSPSPAPSVASCGF 319
Conclusion
Claims 1, 7 and 10-18 are rejected for the reasons as stated above. Applicants must respond to the objections/rejections in this Office action to be fully responsive in prosecution.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE W LEE whose telephone number is (571)272-9949. The examiner can normally be reached on M-F between 9:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571)272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAE W LEE/
Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Prosecution Insights