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 .
Claims Status
Claims 1-26 are cancelled.
Claims 27-41 are pending.
Claims 28 and 35 are amended.
Election/Restrictions
Applicant's election with traverse of Group 1 (Claims 27-28) in the reply filed on 06/25/2026 is acknowledged. The traversal is on the ground(s) that applicant argues that claims 27 and 28 have both endo-b-1,4-xylanse activity and transglycosylase activity and that the reference of Aspeborg does not disclose endo,1,4-xylanase that have an added transglycosylase activity and that for this reason, Aspeborg does not defeat the unity of claims of Group 1-7. Upon further consideration of the Applicant’s argument, the Examiner has modified Group 1 to include claims 27-38. Applicant also argues that, with respect to Groups 8-9, the reference of Chen fails to disclose a high degree of XOS. This is not found persuasive because the instant claims do not recite the requirement of a high degree of XOS. Group 1 and Groups 8-9 do not share the requirement of a special technical feature of a polypeptide with at least 90% sequence identity to SEQ ID NO. 1.
Applicant’s election of Species Group 1: SEQ ID NO: 1 in the reply filed on 06/25/2026 is acknowledged. Applicant did not elect a single species from Species Groups 2-6 that was listed in the Restriction/Election requirement. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 39-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/25/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/12/2024 is acknowledged. The submission is in compliance with the provision of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered.
Claim Rejections - 35 USC § 112
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 27-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a polypeptide with SEQ ID NO.1 that is an endo-b-1,4-xylanse does not reasonably provide enablement for all possible polypeptides that have at least 90% sequence identity to SEQ ID NO: 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required, are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988)) as follows: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claim(s).
Claims 27 (and dependent claims 28-34) are so broad as to encompass any polypeptide with at least 90% sequence identity to SEQ ID NO. 1. The scope of the claim is not commensurate with the enablement provided by the disclosure with regard to utility of the extremely large number of polypeptides broadly encompassed by the claim. Those polypeptides which are encompassed by the claim which consist of polypeptides with at least 90% sequence identity to SEQ ID NO.1 have utility such as endo- b-1,4-xylanses. However, the claimed polypeptides also encompass polypeptides with at least 90% sequence identity to SEQ ID NO.1 which may lack defined function. One of ordinary skill would not reasonably expect such polypeptides to be useful as endo- b-1,4-xylanses as the additional polypeptides may have undefined function or lack endo- b-1,4-xylanse function. As such, the specification fails to teach one of ordinary skill how to use the full scope of the polypeptides encompassed by this claim.
Thus, applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including any number of polypeptides with at least 90% sequence identity to SEQ ID NO. 1.
The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of:
(claim 27 and dependent claims 28-34) a polypeptide with at least 90% sequence identity having the desired biological characteristics and function is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
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 27 (and dependent claims 28-32 and 35-38) are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) a polypeptide with at least 90% sequence identity to SEQ ID NO:1 and a polypeptide according to claim 27 wherein the polypeptide has at least 95% sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2. This judicial exception is not integrated into a practical application because the additional elements to not contribute to any meaningful limitation tot the natural product. The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 27 recites a polypeptide with at least 90% sequence identity to SEQ ID NO: 1 and claim 28 recites wherein the polypeptide has at least 95% sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2. The claims encompass a composition of a polypeptide that is structurally identical to a natural occurring polypeptide as evidenced by UniProt Database Entry A0AAV8WVR9_9CUCU (integrated into UniProtKB/TrEMBL November 24, 2024) that has 99.1% sequence identity to SEQ ID NO: 1 and UniProt Database Entry A0AAV8WV56_9CUCU (integrated into UniProtKB/TrEMBL November 27, 2024) that has 100% sequence identity to SEQ ID NO: 2. UniProt Database Entry A0AAV8WVR9_9CUCU discloses a glycoside hydrolase family 5 domain-containing protein from Rhamnusium bicolor and UniProt Database Entry A0AAV8WVR9_9CUCU discloses a glycoside hydrolase family 5 domain-containing protein from Rhamnusium bicolor. Sequence alignments are presented below:
RESULT 1
A0AAV8WVR9_9CUCU
ID A0AAV8WVR9_9CUCU Unreviewed; 323 AA.
AC A0AAV8WVR9;
DT 27-NOV-2024, integrated into UniProtKB/TrEMBL.
DT 27-NOV-2024, sequence version 1.
DT 28-JAN-2026, entry version 5.
DE RecName: Full=Glycoside hydrolase family 5 domain-containing protein {ECO:0000259|Pfam:PF00150};
GN ORFNames=NQ314_016895 {ECO:0000313|EMBL:KAJ8930345.1};
OS Rhamnusium bicolor.
Query Match 99.1%; Score 1693; Length 323;
Best Local Similarity 99.1%;
Matches 320; Conservative 2; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MNSLLLISLAILGCIINIATSLDAALETVSKHGKLSVNGIQLTDSHGQAVQLKGMSLFWS 60
||| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MNSSLLISLAILGCIINIATSLDAALETVSKHGKLSVNGIQLTDSHGQAVQLKGMSLFWS 60
Qy 61 VWMPYYWNRPTVDSIHSACHSNIVRAAMAVENDGYLTHPDVEMERVETIIEAAIA DDIYV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VWMPYYWNRPTVDSIHSACHSNIVRAAMAVENDGYLTHPDVEMERVETIIEAAIA DDIYV 120
Qy 121 IVDWHDSESEKYLSESKDFFDKISKKYGRYPNIIYETYNEPIGQSWSAVIKPYHQSVINT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 IVDWHDSESEKYLSESKDFFDKISKKYGRYPNIIYETYNEPIGQSWSAVIKPYHQSVINT 180
Qy 181 IRANDPDNVILLGTPHYNQEYDSVINDPITGQRNIMYTLHFYSNEGGNDQLRDRADKAMS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 IRANDPDNVILLGTPHYNQEYDSVINDPITGQRNIMYTLHFYSNEGGNDQLRDRADKAMS 240
Qy 241 AGLPIFVTEYGTSMGSGNGTVDAAATQVWYDWLDGNGISYVNWALSDKDESASSQIAGTP 300
|||||||||||||||||||||:||||||||||||||||||||||||||||||||||||||
Db 241 AGLPIFVTEYGTSMGSGNGTVNAAATQVWYDWLDGNGISYVNWALSDKDESASSQIAGTP 300
Qy 301 PEQACRDNYLTESGRIVVAQNRK 323
|||||:|||||||||||||||||
Db 301 PEQACQDNYLTESGRIVVAQNRK 323
RESULT 1
A0AAV8WV56_9CUCU
ID A0AAV8WV56_9CUCU Unreviewed; 323 AA.
AC A0AAV8WV56;
DT 27-NOV-2024, integrated into UniProtKB/TrEMBL.
DT 27-NOV-2024, sequence version 1.
DT 28-JAN-2026, entry version 5.
DE RecName: Full=Glycoside hydrolase family 5 domain-containing protein {ECO:0000259|Pfam:PF00150};
GN ORFNames=NQ314_016896 {ECO:0000313|EMBL:KAJ8930346.1};
OS Rhamnusium bicolor.
Query Match 100.0%; Score 1703; Length 323;
Best Local Similarity 100.0%;
Matches 323; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MNSSLLISLAILSCIINIATSLDAAQETVSKHGKLSVNGIRLTDSHGQPVQLKGMSLFWS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MNSSLLISLAILSCIINIATSLDAAQETVSKHGKLSVNGIRLTDSHGQPVQLKGMSLFWS 60
Qy 61 VWMPYYWNRATVDSIHKACHSNIVRAAMAVENDGYLTHPDVEMERVETIIEAAIA NDIYV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VWMPYYWNRATVDSIHKACHSNIVRAAMAVENDGYLTHPDVEMERVETIIEAAIA NDIYV 120
Qy 121 IVDWHDSDSEKHLAESKDFFDKISKKYGRYPNIIYETYNEPISQSWSAVIKPYHQSIIST 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 IVDWHDSDSEKHLAESKDFFDKISKKYGRYPNIIYETYNEPISQSWSAVIKPYHQSIIST 180
Qy 181 IRSNDQDNVIIVGVPHFDQEYDQAINDPITGQRNIMYTLHFYSNEGGNDQLRDRADKAMS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 IRSNDQDNVIIVGVPHFDQEYDQAINDPITGQRNIMYTLHFYSNEGGNDQLRDRADKAMS 240
Qy 241 AGLPIFVTEYGTSMGSGNGTVNAAATQVWYDWLDRNGLSYVNWALSDKDESASSQKAGTP 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 AGLPIFVTEYGTSMGSGNGTVNAAATQVWYDWLDRNGLSYVNWALSDKDESASSQKAGTP 300
Qy 301 PEQACQDNYLTESGRIVVAQNKK 323
|||||||||||||||||||||||
Db 301 PEQACQDNYLTESGRIVVAQNKK 323
Because there is no difference in characteristics (structural, functional, or otherwise) between the claimed and naturally occurring composition, the claimed composition does not have markedly different characteristics and thus is a product of nature exception. Accordingly, the product is directed to an exception (Step 2A: Yes). Because the claims do not include any additional features that could add significantly more to the exception (Step 2B: No), the claims do not qualify as eligible subject matter and are rejected.
Closest Prior Art
Aspeborg et al. “Evolution, substrate specificity and subfamily classification of glycoside hydrolase family 5 (GH5)”, BMC Evolutionary Biology, Vol. 12:186, doi: 10.1186/1471-2148-12-196; published September 20, 2012.
Jaichakan et al. “Two-stage processing for xylooligosaccharide recovery from rice by-products and evaluation of products: Promotion of lactic acid-producing bacterial growth and food application in a high-pressure process” vol. 147:110529; published 2021.
Pauchet et al. “Analyzing the substrate specificity of a class of Long-Horned Beetle-Derived Xylanases by using synthetic arabinoxylan oligo- and polysaccharides”, ChemBioChem, Vol. 21, pg. 1517-1525; published January 21, 2020.
St. John et al. “Glycosyl Hydrolase xylanses, compositions and methods of use for efficient hydrolysis and processing of xylan” US Patent Application Publication No. US 2016/0040203A1; published February 11, 2016.
Zheng et al. “An endoxylanse rapidly hydrolyzes xylan into major product xylobiose via transglycosylation of xylose to xylotriose or xylotetraose” Carbohydrate Polymers, Vol. 237, pg. 116121; published 2020.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE T LOUNTOS whose telephone number is (571)272-0502. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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/GEORGE THEMISTOCLIS LOUNTOS/ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652
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