DETAILED ACTION
Status of Application
The amendments and response filed 25 February 2026 are acknowledged and have been considered in their entireties. Claim 6 is cancelled, thus, claims 1, 3, 5 and 7-18 remain pending; Claims 1, 3, 5 and 7-17 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claim 18 remains subject to examination on the merits.
Withdrawal of Previous Objections/Rejections
The objection to the specification for reference to positions in SEQ ID NO: 1 which were off by single numbers (E.g. referencing H59 rather than H58, etc.) is withdrawn in view of the amendments to the specification.
The rejection of claim 18 under 35 U.S.C. 112(a), written description is withdrawn in view of the amendments to recite which xanthine amide hydrolases are utilized in the method.
The rejection of claim 18 under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (WO 2019183292 – cited previously) in view of UniProt A0A336K523 - Allantoinase from Cytobacillus firmus (Bacillus firmus) – deposited 2018 and cited previously, and Guo et al. (Scientific Reports, 2016 – cited previously).
It is noted, said UniProt A0A336K523 reference was cited previously but inadvertently not included in the previous Office action. It is included herein for completeness of record.
New Rejection
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.
Claim 18 is 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.
The claim recites that the natural isozyme is selected from the group consisting of Bacillus firmus, Compost metagenome, etc.; and wherein the natural isozyme is anyone of the amino acid sequences selected from SEQ ID NOs: 4-104.
However, stating the natural isozymes are selected from Bacillus firmus, Compost metagenome is improper because these are microorganism species and are not enzymes/isozymes. It is suggested, to overcome this rejection, to stipulate that the isozymes are derived from the noted species.
Claim 18 is further 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.
The claim recites that the functional variant has a catalytic site defined as follows in spatial conformation: the catalytic site comprises amino acid residues H59, H61, K151, H186, H242, and D316 that are close to each other in spatial conformation and refer to SEQ ID NO: 1.
However, for example, natural isozyme of SEQ ID NO: 4 does not have these exact amino acids in those exact same referenced numbered positions. There is a His at position 60; and another at position 62; but there are none at positions 58 and 60. Applicant’s overcome this rejection by stating the amino acids correspond to these positions in SEQ ID NO: 1. Below is SEQ ID NO: 4, catalytic residues appear to be in yellow, bold and underlined; metal binding site in green, bold and underlined.
The claim will be interpreted that the recited catalytic site residues and metal binding site residues correspond to those positions recited for SEQ ID NO: 1.
<210> 4
<211> 531
<212> PRT
<213> Clostridium purinilytica
<220>
<223>xanthine amide hydrolase
<400> 4
Met Tyr Asp Leu Ile Leu Lys Asn Ala Arg Ile Pro Gln Gly Asp Asp
1 5 10 15
Thr Ile Val Thr Asn Ile Leu Val Arg Asp Glu Lys Ile Ala Gly Phe
20 25 30
Thr Asp Cys Ile Glu Glu Val Gln Ala Lys Glu Ile Ile Asp Ile Glu
35 40 45
Gly Gln Leu Thr Leu Pro Gly Cys Ile Asp Ser His Thr His Phe Met
50 55 60
Tyr Gln Gly Phe Pro His Arg Glu Asn Phe Leu Thr Gly Thr Ala Ala
65 70 75 80
Ala Ala Thr Gly Gly Ile Thr Thr Val Ile Asp Met Pro Cys Cys Ser
85 90 95
Val Pro Ser Ala Arg Ser Val Glu Gln Leu Gln Leu Lys Ile Asp Leu
100 105 110
Cys Gln Pro Gln Ser Leu Val Asp Phe Ala Met Trp Gly Gly Val Thr
115 120 125
Gly Glu Asp Val Arg Glu Asp Trp Met His Asn Val Lys Glu Gln Ala
130 135 140
Asp Tyr Gly Val Val Ala Phe Lys Val Tyr Met Thr Pro Ser Val Pro
145 150 155 160
Thr Tyr Pro Arg Val Thr Asp Pro Glu Met Leu Glu Cys Phe Arg Ala
165 170 175
Val Ala Glu Thr Gly Leu Pro Ile Gly Ile His Ala Glu Asn Phe Ala
180 185 190
Met Cys Asp Phe Tyr Val Lys Lys Phe Gln Lys Glu Gly Arg Met Asp
195 200 205
Gly Pro Ala Trp Ala Glu Ala Arg Met Glu Leu Ala Glu Lys Val Ala
210 215 220
Ile Glu Leu Gly Ile Ser Phe Ala Glu Asp Thr Gly Ala Arg Leu His
225 230 235 240
Ile Val His Met Ser Thr Gly Ile Gly Ala Lys Leu Val Gly Glu Ala
245 250 255
Lys Lys Arg Gly Ile Asn Val Thr Ser Glu Thr Cys Pro His Tyr Leu
260 265 270
Thr Leu Asn Tyr Gln Asp Ala Met Ser Glu Tyr Gly Ala Phe Ala Lys
275 280 285
Ile Ala Pro Pro Leu Arg Thr Lys Arg Asp Asn Glu Glu Leu Trp Glu
290 295 300
Gly Leu Asn Asn Gly Ser Val Asp Phe Ile Ala Thr Asp His Ala Pro
305 310 315 320
Tyr Glu Ile Glu Ser Glu Lys Ala Lys Glu Gly Met Asn Ile Trp Thr
325 330 335
Ala Phe Pro Gly Ile Pro Gly Val Glu Thr Met Val Pro Val Leu Val
340 345 350
Ser Glu Gly Tyr Asn Lys Gly Arg Leu Ser Leu Ser Lys Leu Val Asp
355 360 365
Ile Leu Ser Thr Asn Ala Ala Lys His Tyr Gly Leu Tyr Pro Lys Lys
370 375 380
Gly Ala Leu Asn Ile Gly Ser Asp Ala Asp Phe Thr Val Ile Asp Leu
385 390 395 400
Asp Arg Glu Trp Thr Ile Thr Lys Asp Met Val Thr Met Cys Gly Tyr
405 410 415
Asn Pro Leu Glu Gly Leu Lys Leu Lys Gly Lys Pro Val Lys Thr Ile
420 425 430
Val Arg Gly His Ile Val Tyr Gln Asp Gly Glu Glu Gly Ala Leu Pro
435 440 445
Ser Leu Thr Asp Glu Glu Leu Lys Thr Ile Val His Glu Tyr Pro Ala
450 455 460
Gly Val Glu Glu Lys Tyr Ser Gly Val Phe Glu Gly Phe Pro His Leu
465 470 475 480
His Ser Ala Glu Tyr Glu Arg Ser Tyr Arg Lys Glu His Pro Glu Val
485 490 495
Ile Asp Glu His Ile Arg Gly Ile Lys Gly Ile Met Val Lys Pro Gly
500 505 510
Phe Gly Gln Phe Val Lys Arg Gln Ser Ile Gln Val Leu Pro Lys Thr
515 520 525
Ile Thr Tyr
530
Sequence alignment between instant SEQ ID NO: 1 (Qy) and SEQ ID NO: 4 (Db).
GenCore version 6.5.2
Copyright (c) 1993 - 2026 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: April 1, 2026, 15:05:43 ; Search time 1 Seconds
(without alignments)
0.258 Million cell updates/sec
Title: US-17-793-014A-1
Perfect score: 2538
Sequence: 1 DLILKNASIPQGDRQVLTNI..........FKYEKYEAVKAKTKDPVAQQ 485
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 531 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-17-793-014A-4.fasta:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 1547.5 61.0 531 1 US-17-793-014A-4 XANTHINE AMIDE HYD
ALIGNMENTS
RESULT 1
US-17-793-014A-4
Query Match 61.0%; Score 1547.5; DB 1; Length 531;
Best Local Similarity 55.5%;
Matches 294; Conservative 72; Mismatches 101; Indels 63; Gaps 3;
Qy 1 DLILKNASIPQGDRQVLTNILVNEGKIVGYTNDISFLNAARVIDIKGKLVVPGCIDPHTH 60
||||||| ||||| ::||||| : || |:|: | : | :|||:|:| :||||| |||
Db 3 DLILKNARIPQGDDTIVTNILVRDEKIAGFTDCIEEVQAKEIIDIEGQLTLPGCIDSHTH 62
Qy 61 FMDPGFTHRETFATGSRSAAAGGLTTIIDMPCCSKPSVRDGESFNKKIGPIRDQAYIDYC 120
|| || ||| | ||: :|| ||:||:||||||| || | | || : |: :|:
Db 63 FMYQGFPHRENFLTGTAAAATGGITTVIDMPCCSVPSARSVEQLQLKIDLCQPQSLVDFA 122
Qy 121 FWGGMTGEDAREGWIDNIYPQIDQGVVAFKVYMTPSVPTFPKVSDAEMLEIFSNVAKTGL 180
|||:|||| || |: |: | | |||||||||||||||:|:|:| |||| | ||:|||
Db 123 MWGGVTGEDVREDWMHNVKEQADYGVVAFKVYMTPSVPTYPRVTDPEMLECFRAVAETGL 182
Qy 181 PIGVHAENYDICTFYSKKLEKEGRLDGPAWAEARSSLAEKVAIELILSFAEATDARVHVV 240
|||:||||: :| || || :||||:||||||||| ||||||||| :|||| | ||:|:|
Db 183 PIGIHAENFAMCDFYVKKFQKEGRMDGPAWAEARMELAEKVAIELGISFAEDTGARLHIV 242
Qy 241 HMSTKEGVELVKAAKKRGVKVTAETCPHYLVLNAKDSMSERGSYAKIAPPLRGKEDNESH 300
|||| | :|| |||||: ||:||||||| || :|:||| |::|||||||| | |||
Db 243 HMSTGIGAKLVGEAKKRGINVTSETCPHYLTLNYQDAMSEYGAFAKIAPPLRTKRDNEEL 302
Qy 301 WQALADGTIDFVGTDHAPYEIATEKDYPGATIWNTFPGIPGVETMVPILVSEGLNKGRLS 360
|: | :|::||: |||||||| :|| | || ||||||||||||:||||| ||||||
Db 303 WEGLNNGSVDFIATDHAPYEIESEKAKEGMNIWTAFPGIPGVETMVPVLVSEGYNKGRLS 362
Qy 361 LSRFVEVTSRNAAIHYGIYPKKGSMEIGSDADFTVIDLEKEYVIDEQKTESMAKYNPLHG 420
||: |:: | ||| |||:|||||:: ||||||||||||::|: | : :| |||| |
Db 363 LSKLVDILSTNAAKHYGLYPKKGALNIGSDADFTVIDLDREWTITKDMV-TMCGYNPLEG 421
Qy 421 MKLKGKPVQTIIRGNVIF------------DED--------------------------- 441
:|||||||:||:||:::: ||:
Db 422 LKLKGKPVKTIVRGHIVYQDGEEGALPSLTDEELKTIVHEYPAGVEEKYSGVFEGFPHLH 481
Qy 442 -----------------------KGIVGEAGYGEYVPRQSIQRLERTFKY 468
|||: : |:|::| ||||| | :| |
Db 482 SAEYERSYRKEHPEVIDEHIRGIKGIMVKPGFGQFVKRQSIQVLPKTITY 531
Search completed: April 1, 2026, 15:05:43
Job time : 1 secs
Claim 18 is further 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.
The claim recites that the naturally occurring isozyme of SEQ ID NO: 1, comprises any of SEQ ID NOs: 4-104. However, SEQ ID NO: 52 has 100% sequence identity to instant SEQ ID NO: 1 and thus it cannot possibly be a “naturally occurring isozyme” of SEQ ID NO: 1. The alignment is shown below. Qy = SEQ ID NO: 1 and Db = SEQ ID NO: 52. (Also see Supplemental Content, 20250703_112323_us-17-793-014a-1.rapbm file, Result #2)
GenCore version 6.5.2
Copyright (c) 1993 - 2026 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: April 1, 2026, 15:40:09 ; Search time 1 Seconds
(without alignments)
0.236 Million cell updates/sec
Title: US-17-793-014A-1
Perfect score: 2538
Sequence: 1 DLILKNASIPQGDRQVLTNI..........FKYEKYEAVKAKTKDPVAQQ 485
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 486 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-17-793-014A-52.fasta:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 2538 100.0 486 1 US-17-793-014A-52 XANTHINE AMIDE HYD
ALIGNMENTS
RESULT 1
US-17-793-014A-52
Query Match 100.0%; Score 2538; DB 1; Length 486;
Best Local Similarity 100.0%;
Matches 485; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLILKNASIPQGDRQVLTNILVNEGKIVGYTNDISFLNAARVIDIKGKLVVPGCIDPHTH 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2 DLILKNASIPQGDRQVLTNILVNEGKIVGYTNDISFLNAARVIDIKGKLVVPGCIDPHTH 61
Qy 61 FMDPGFTHRETFATGSRSAAAGGLTTIIDMPCCSKPSVRDGESFNKKIGPIRDQAYIDYC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 62 FMDPGFTHRETFATGSRSAAAGGLTTIIDMPCCSKPSVRDGESFNKKIGPIRDQAYIDYC 121
Qy 121 FWGGMTGEDAREGWIDNIYPQIDQGVVAFKVYMTPSVPTFPKVSDAEMLEIFSNVAKTGL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 122 FWGGMTGEDAREGWIDNIYPQIDQGVVAFKVYMTPSVPTFPKVSDAEMLEIFSNVAKTGL 181
Qy 181 PIGVHAENYDICTFYSKKLEKEGRLDGPAWAEARSSLAEKVAIELILSFAEATDARVHVV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 182 PIGVHAENYDICTFYSKKLEKEGRLDGPAWAEARSSLAEKVAIELILSFAEATDARVHVV 241
Qy 241 HMSTKEGVELVKAAKKRGVKVTAETCPHYLVLNAKDSMSERGSYAKIAPPLRGKEDNESH 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 242 HMSTKEGVELVKAAKKRGVKVTAETCPHYLVLNAKDSMSERGSYAKIAPPLRGKEDNESH 301
Qy 301 WQALADGTIDFVGTDHAPYEIATEKDYPGATIWNTFPGIPGVETMVPILVSEGLNKGRLS 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 302 WQALADGTIDFVGTDHAPYEIATEKDYPGATIWNTFPGIPGVETMVPILVSEGLNKGRLS 361
Qy 361 LSRFVEVTSRNAAIHYGIYPKKGSMEIGSDADFTVIDLEKEYVIDEQKTESMAKYNPLHG 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 362 LSRFVEVTSRNAAIHYGIYPKKGSMEIGSDADFTVIDLEKEYVIDEQKTESMAKYNPLHG 421
Qy 421 MKLKGKPVQTIIRGNVIFDEDKGIVGEAGYGEYVPRQSIQRLERTFKYEKYEAVKAKTKD 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 422 MKLKGKPVQTIIRGNVIFDEDKGIVGEAGYGEYVPRQSIQRLERTFKYEKYEAVKAKTKD 481
Qy 481 PVAQQ 485
|||||
Db 482 PVAQQ 486
Search completed: April 1, 2026, 15:40:10
Job time : 2 secs
Modified Rejection – Necessitated by Amendments
Claim Rejections - 35 USC § 103
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 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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (WO 2019183292 – cited previously) in view of UniProt A0A0L0W692 - L-hydantoinase E.C. 3.5.2.5 from Gottschalkia purinilytica (Clostridium purinilyticum) – deposited 2015 and cited herein, and Guo et al. (Scientific Reports, 2016 – cited previously).
Hoffman et al. teach methods of treating gout by administering an enucleated cell comprising a uric acid degrading polypeptide selected from those including allantoinase, wherein said allantoinases have enzyme commission number EC 3.5.2.5 (See claim 7, 16, 30, 114-134, 135-140; p. 34, lines 18-24; p. 38, line 28 to p. p. 40, line 24). With regard to the limitation that “wherein a gene encoding the polypeptide functional variant is integrated into an E. coli genome, and a promoter controlling guanine transporter and guanine deaminase is replaced with a gapA promoter”, it is noted the wherein clause is interpreted as a product by process limitation. The claims are drawn to administering the polypeptide functional variant not administering an E. coli host cell (notably, these were restricted and are drawn to unelected Group II). Thus, it is immaterial how the polypeptide functional variant is made or presents itself (See MPEP 2113).
Hoffman et al., however, do not specify which allantoinase having E.C. 3.5.2.5 is utilized in the method of treating gout. Nonetheless, Hoffman et al. do point out that any allantoinase having EC 3.5.2.5 will function in their invention of methods of treating gout by administering enucleated cells comprising said enzymes.
Guo et al. teach that gout patients suffer due to an increase in uric acid (See p. 1, 1st paragraph), and that in patients with gout flares, said patients had increased xanthine dehydrogenase which degrades xanthine to uric acid, however, uric acid was not broken down because there was a depletion of allantoinase which breaks down said uric acid to urea (See p. 5, last paragraph to top of p. 6; p. 7, 1st paragraph).
The UniProt A0A0L0W692 discloses a known allantoinase (hydantoinase) since 2015, has EC 3.5.2.5, and a naturally occurring isozyme of SEQ ID NO: 1 and is from Clostridium purinilyticum having the exact same corresponding claimed catalytic and metal binding site amino acids (See alignment and sequence above), and having 100% sequence identity with instant SEQ ID NO: 4 – See Supplemental Content, file 0241230_081737_us-17-793-014a-4.rup, Result #1). Said sequence has the following corresponding amino acids: H58, H60, K150, H185, H241, D315; and I287, A288, P337 and G338 according to the numbering and alignment with instant SEQ ID NO: 1 (but which adds two to each position compared to SEQ ID NO: 1).
Therefore, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to utilize any known allantoinase of EC 3.5.2.5, such as that disclosed in 2015 from Clostridium purinilyticum having UniProt A0A0L0W692 in the method of treating gout of Hoffman et al. because Hoffman et al. suggest it and because Guo et al. teach that uric acid, a hallmark of gout flares, is not broken down to urea because there is not enough allantoinase present. This provides motivation in and of itself to utilize any known any known allantoinase of EC 3.5.2.5 as suggested by Hoffman et al., such as that disclosed in 2015 from Clostridium purinilyticum firmus having UniProt A0A0L0W692 because it is known and characterized enzyme. Further, the selection of a known material based on its suitability for its intended use supports the determination of prima facie obviousness (MPEP 2144.07; See also Sinclair & Carroll Co. v. Interchemical Corp. 325 U.S. 327, 65 USPQ 297 (1945)). One skilled in the art would have a reasonable expectation of success to utilize the known UniProt A0A0L0W692 allantoinase given Hoffman et al. suggest that any allantoinase having EC 3.5.2.5 will work and because Guo et al. acknowledge that increased uric acid is present in gout patients because there is not enough present to break it down to urea.
As such, the references when combined render the instant claims as prima facie obvious.
Applicant’s Response and Examiner’s Rebuttal:
Applicant’s state the previous teachings fail to teach each and every element of the as amended claim(s). Specifically the combined references fail to teach the functional variant, naturally isozyme to SEQ ID NO: 1, selected from any of SEQ ID NOs: 4-104.
The Examiner acknowledges this and has modified the rejection in accordance with the amendments made to the claim.
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 18 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-16, 18, 20-25 of copending Application No. 17793009 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘009 application render obvious the instant claims.
The instant claim is drawn to a method of treating and/or preventing gout by administering a functional variant of an xanthine amide hydrolase comprising SEQ ID NO: 1, wherein the functional variant has xanthine amide hydrolase activity; the functional variant has a catalytic site defined as follows in spatial conformation: the catalytic site comprises amino acid residues H58, H60, K150, H185, H241, and D315 that are close to each other in spatial conformation and refer to SEQ ID NO:1, and the catalytic site further comprises a divalent metal ion; and the functional variant has a binding site defined as follows in spatial conformation: the binding site comprises amino acid residues I287, A288, P337 and G338 of SEQ ID NO: 1 that are close to each other in spatial conformation; and is a naturally occurring isozyme selected from SEQ ID NOs: 4-104.
The claims to the ‘009 application are drawn to a pharmaceutical composition or health food used for prevention, intervention or treatment of gout comprising a polypeptide A (a 4-ureido-5-carboxyimidazole amide hydrolase) and a polypeptide A comprising SEQ ID NO: 103, or a functional variant thereof, and having xanthine amide hydrolase activity, nucleic acids encoding the same; and methods of treating gout by administering a polypeptide A of claim 1 (See claim 19) .
Instant SEQ ID NO: 1/52 and SEQ ID NO: 103 of the ‘009 application have 100% sequence identity to one another (See Supplemental Content, 20241230_081738_us-17-793-014a-1.rapbm file, Result #1) and thus they possess the same catalytic site residues of H59, H61, K151, H186, H242, and D316; and binding residues of I288, A289, P338 and G339; wherein according to the instant claims, SEQ ID NO: 52 is a naturally occurring isozyme of SEQ ID NO: 1.
Thus, the difference between the claims is the intended use of the composition comprising the same xanthine amide hydrolase for prevention, intervention and/or treatment of gout in the reference ‘009 application vs the actual method of treating using said xanthine amide hydrolase as in the instant claims. However, it would be obvious to utilize the composition of the ‘009 application in a method prevention, intervention and/or treatment of gout which it was intended for – See Geneva Pharms. Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, (Fed. Cir. 2003), Pfizer v. Teva, 518 F.3d 1353 (Fed Cir. 2008) and Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010) and MPEP 804.01.
In addition, as in withdrawn claim 19 of the ‘009 application, the composition is intended to be used to treat gout.
As noted above, how the protein functional variant is made is interpreted as a product by process limitation and it does not change the polypeptide itself or the method of treating using said polypeptide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s Comment:
Applicant notes that the non-statutory double patenting rejection is provisional rejection, and both applications are still pending. It is asserted that Applicant will address this rejection upon indication of allowable subject matter (Remarks, p. 10).
The Examiner acknowledges Applicant’s comment. The rejection of record is maintained for the reasons of record.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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, 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 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.
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 01 April 2026
Prosecution Insights