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 .
This office action is in response to the amendment filed on December 29, 2025. New claims 6-8 have been added. Claims 1-8 are currently pending and are under examination.
Withdrawal of Rejections
The rejection of claim(s) 1-3 under 35 U.S.C. 102(a)(1) as being anticipated by Shestopal et al. (J Thromb Haemost 15: 709-720 (2017)) is withdrawn based on the amendment to the claims to recite different factor VIII polypeptides.
The rejection of claim(s) 3 under 35 U.S.C. 102(a)(2) as being anticipated by Lollar (U.S. Patent 7,635,763 B2) is withdrawn based on the 35 USC 102(b)(2)(C) statement regarding owned by the same person or subject to an obligation of assignment to the same person.
The rejection of claim(s) 1-5 under 35 U.S.C. 102(a)(2) as being anticipated by Lollar (U.S. Patent 8,188,246 B2) is withdrawn based on the 35 USC 102(b)(2)(C) statement regarding owned by the same person or subject to an obligation of assignment to the same person.
The rejection of claim(s) 4 and 5 under 35 U.S.C. 103 as being unpatentable over Shestopal et al. (J Thromb Haemost 15: 709-720 (2017)) in view of Lollar (U.S. Patent 8,188,246 B2) is withdrawn based on the amendment to the claims to recite different factor VIII polypeptides and based on the 35 USC 102(b)(2)(C) statement regarding owned by the same person or subject to an obligation of assignment to the same person.
Pending Rejections
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.
Claims 1, 3, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 7,635,763 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of overlapping scope. The species have overlapping sequence identity as currently claimed in the instant application.
Lollar (U.S. Patent No. 7,635,763 B2) disclose an isolated nucleic acid molecule encoding a modified factor VIII polypeptide comprising a nucleotide sequence having at least 99.7% sequence identity to the polynucleotide sequence shown in SEQ ID NO: 18, wherein said nucleotide sequence encodes a polypeptide characterized by high-level expression when compared to a corresponding human factor VIII polypeptide expressed under the same conditions (see claim 1). The encoded polypeptide from SEQ ID NO: 18 of the issued patent has 99.7% sequence identity to SEQ ID NO: 19 of the pending application (see alignment in Non-Final mailed on 7/28/2025 in 35 U.S.C. 102(a)(2) rejection. It would have been obvious to the person having ordinary skill in the art to isolate the modified factor VIII polypeptide, because the issued patent discloses the method of isolating the polypeptide after recombinant expression (see claims 11-14). Therefore, the isolated modified factor VIII polypeptide is obvious to the person having ordinary skill in the art.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-11 of U.S. Patent No. 8,188,246 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the species are of overlapping scope.
Lollar (U.S. Patent 8,188,246 B2) disclose an isolated polypeptide comprising an amino acid sequence having at least 99.7% sequence identity to SEQ ID NO: 19. A method of increasing the level of expression of a factor VIII polypeptide in a cell comprising: a) introducing into said cell a nucleic acid molecule comprising a nucleotide sequence having at least 99.7% sequence identity to SEQ ID NO: 18, wherein said sequence encodes said factor VIII polypeptide and said factor VIII polypeptide is characterized by high expression; and b) culturing said cell under conditions that allow expression of said nucleic acid molecule. The method, wherein said nucleic acid molecule comprises a nucleotid a nucleotide sequence comprising the sequence set forth in SEQ ID NO: 18. The method, further comprising isolating said polypeptide. The method, further comprising isolating said polypeptide. A method of treating a factor VIII deficiency comprising administering to a subject in need thereof a composition comprising a therapeutically effective amount of a polypeptide, wherein said polypeptide comprises an amino acid sequence having at least 99.7% sequence identity to SEQ ID NO: 19 and said polypeptide is characterized by high-level expression. An isolated polypeptide comprising an amino acid sequence having at least 99.7% sequence identity to SEQ ID NO: 19, wherein said polypeptide is characterized by high-level expression as compared to a corresponding human factor VIII polypeptide expressed under the same conditions. A composition comprising a polypeptide and a pharmaceutically acceptable carrier. The composition, wherein the composition treats a factor VIII deficiency (see alignment in Non-Final mailed on 7/28/2025 in 35 U.S.C 102(a)(2) of SEQ ID NO: 18 of issued patent (identified as Query) and SEQ ID NO: 19 of instant application (identified as Sbjct) and claims 1-11 of issued patent). The variability of amino acids in SEQ ID NO: 19 of the issued patent to the currently claimed factor VIII polypeptide sequences in the instant application are disclosed in corresponding issued patent SEQ ID NO: sequences that have factor VIII activity (e.g. SEQ ID NO: 20), so that it would have been obvious to the person having ordinary skill in the art to arrive at SEQ ID NOs of the pending application that would result in 100% identity with factor VIII polypeptides with similar functional activity, therefore claims 2, and 6-8 are also rejected.
Claims 1, 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 20-27 of U.S. Patent No. 10,058,624 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the species are of overlapping scope.
Doering et al. (U.S. Patent 10,058,624 B2) disclose an isolated polynucleotide, e.g. at least 90% identical to SEQ ID NO: 12; SEQ ID NO: 12 comprises a sequence having at least 99.3% sequence identity to SEQ ID NO: 20. A method of treating a factor VIII deficiency (hemophilia A) comprising administering to a subject in need thereof a composition comprising a therapeutically effective amount of a vector, wherein said polynucleotide sequence having at least 99.3% sequence identity to SEQ ID NO: 20. A composition comprising the vector and a pharmaceutically acceptable carrier. The composition, wherein the composition treats a factor VIII deficiency (see alignment below in 35 U.S.C 102(a)(2) of SEQ ID NO: 20 of the pending application (identified as Qy) and SEQ ID NO: 12 of the issued patent (identified as Db) and claims 1 and 20-27).
It would have been obvious to the person having ordinary skill in the art to further isolate the active ingredient, factor VIII, and administer the active ingredient as a pharmaceutical composition to treat the blood clotting disorder of hemophilia A, because Doering et al. disclose the use of the nucleic acid that is encoding the same polypeptide factor VIII to treat the same patient population.
Claims 1, 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 11-18 of U.S. Patent No. 10,898,588 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the species are of overlapping scope.
Doering et al. (U.S. Patent 10,898,588 B2) disclose an isolated polynucleotide, e.g. at least 90% identical to SEQ ID NO: 12; SEQ ID NO: 12 comprises a sequence having at least 99.3% sequence identity to SEQ ID NO: 20. A method of treating a factor VIII deficiency (hemophilia A) comprising administering to a subject in need thereof a composition comprising a therapeutically effective amount of a vector, wherein said polynucleotide sequence having at least 99.3% sequence identity to SEQ ID NO: 20. A composition comprising the vector and a pharmaceutically acceptable carrier. The composition, wherein the composition treats a factor VIII deficiency (see alignment below in 35 U.S.C 102(a)(2) of SEQ ID NO: 20 of the pending application (identified as Qy) and SEQ ID NO: 12 of the issued patent (identified as Db) and claims 1-18 of issued patent).
It would have been obvious to the person having ordinary skill in the art to further isolate the active ingredient, factor VIII, and administer the active ingredient as a pharmaceutical composition to treat the blood clotting disorder of hemophilia A, because Doering et al. disclose the use of the nucleic acid that is encoding the same polypeptide factor VIII to treat the same patient population.
Claim Rejections - 35 USC § 112
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 1-8 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 1 refers to an isolated modified factor VIII polypeptide comprising a nucleotide sequence. It is unclear how a polypeptide comprises a nucleotide sequence. Clarification is requested as to whether the claims are drawn to a polypeptide or a polynucleotide.
Claims dependent on a rejected claim are rejected for failing to cure the indefiniteness.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 3-5 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Doering et al. (U.S. Patent No. 10,058,624 B2).
Doering et al. (U.S. Patent 10,058,624 B2) disclose an isolated polynucleotide, e.g. at least 90% identical to SEQ ID NO: 12 (see claim 25); SEQ ID NO: 12 comprises a sequence having at least 99.3% sequence identity to SEQ ID NO: 20. A method of treating a factor VIII deficiency (hemophilia A) comprising administering to a subject in need thereof a composition comprising a therapeutically effective amount of a vector, wherein said polynucleotide sequence having at least 99.3% sequence identity to SEQ ID NO: 20. A composition comprising the vector and a pharmaceutically acceptable carrier. The composition, wherein the composition treats a factor VIII deficiency (see alignment below of SEQ ID NO: 20 of the pending application (identified as Qy) and SEQ ID NO: 12 of the issued patent (identified as Db) (claims 1 and 20-27)). Claim 1 of the pending application claims a polypeptide comprising a nucleotide sequence.
Alignment Scores:
Length: 4404
Score: 7773.00 Matches: 1455
Percent Similarity: 99.3% Conservative: 2
Best Local Similarity: 99.2% Mismatches: 0
Query Match: 99.7% Indels: 10
Gaps: 1
US-17/632,222 (SEQ ID NO: 20) (1-1457) x US-15/128,912 (SEQ ID NO:12) (1-4404)
Qy 1 MetGlnLeuGluLeuSerThrCysValPheLeuCysLeuLeuProLeuGlyPheSerAla 20
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ATGCAGCTGGAACTGTCTACCTGTGTGTTTCTGTGTCTGCTGCCTCTGGGGTTTTCTGCT 60
Qy 21 IleArgArgTyrTyrLeuGlyAlaValGluLeuSerTrpAspTyrArgGlnSerGluLeu 40
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ATCCGCCGCTACTATCTGGGAGCCGTGGAGCTGTCCTGGGACTACAGGCAGAGCGAGCTG 120
Qy 41 LeuArgGluLeuHisValAspThrArgPheProAlaThrAlaProGlyAlaLeuProLeu 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 CTGAGAGAACTGCACGTGGATACCAGATTCCCAGCTACCGCTCCAGGAGCTCTGCCTCTG 180
Qy 61 GlyProSerValLeuTyrLysLysThrValPheValGluPheThrAspGlnLeuPheSer 80
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GGCCCATCCGTGCTGTACAAGAAAACCGTCTTCGTGGAGTTTACCGACCAGCTGTTCAGC 240
Qy 81 ValAlaArgProArgProProTrpMetGlyLeuLeuGlyProThrIleGlnAlaGluVal 100
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GTGGCCAGGCCAAGACCACCTTGGATGGGACTGCTGGGACCAACCATCCAGGCTGAGGTG 300
Qy 101 TyrAspThrValValValThrLeuLysAsnMetAlaSerHisProValSerLeuHisAla 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 TACGATACCGTGGTCGTGACCCTGAAAAACATGGCCTCCCATCCCGTGAGCCTGCACGCT 360
Qy 121 ValGlyValSerPheTrpLysSerSerGluGlyAlaGluTyrGluAspHisThrSerGln 140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 GTCGGGGTGTCCTTCTGGAAGTCCAGCGAGGGAGCCGAGTACGAAGACCATACCTCCCAG 420
Qy 141 ArgGluLysGluAspAspLysValLeuProGlyLysSerGlnThrTyrValTrpGlnVal 160
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 CGCGAGAAAGAAGACGATAAGGTGCTGCCTGGCAAAAGCCAGACCTATGTCTGGCAGGTG 480
Qy 161 LeuLysGluAsnGlyProThrAlaSerAspProProCysLeuThrTyrSerTyrLeuSer 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 CTGAAGGAGAACGGACCAACCGCTAGCGACCCACCATGCCTGACCTACTCTTATCTGTCC 540
Qy 181 HisValAspLeuValLysAspLeuAsnSerGlyLeuIleGlyAlaLeuLeuValCysArg 200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 CACGTCGATCTGGTGAAGGACCTGAATTCCGGACTGATCGGAGCTCTGCTGGTGTGTAGA 600
Qy 201 GluGlySerLeuThrArgGluArgThrGlnAsnLeuHisGluPheValLeuLeuPheAla 220
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 GAGGGAAGCCTGACCAGAGAAAGAACCCAGAACCTGCATGAGTTCGTCCTGCTGTTCGCC 660
Qy 221 ValPheAspGluGlyLysSerTrpHisSerAlaArgAsnAspSerTrpThrArgAlaMet 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 GTGTTTGACGAAGGGAAGAGCTGGCACTCTGCCCGCAATGACTCCTGGACCAGAGCTATG 720
Qy 241 AspProAlaProAlaArgAlaGlnProAlaMetHisThrValAsnGlyTyrValAsnArg 260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 GATCCAGCTCCTGCTAGAGCTCAGCCTGCTATGCACACCGTCAACGGCTACGTGAATCGG 780
Qy 261 SerLeuProGlyLeuIleGlyCysHisLysLysSerValTyrTrpHisValIleGlyMet 280
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 TCTCTGCCAGGACTGATCGGCTGCCATAAGAAAAGCGTCTATTGGCACGTGATCGGAATG 840
Qy 281 GlyThrSerProGluValHisSerIlePheLeuGluGlyHisThrPheLeuValArgHis 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 GGCACCAGCCCCGAGGTGCATTCTATCTTCCTGGAAGGCCACACCTTTCTGGTCAGGCAC 900
Qy 301 HisArgGlnAlaSerLeuGluIleSerProLeuThrPheLeuThrAlaGlnThrPheLeu 320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 CATAGACAGGCCTCTCTGGAGATCTCCCCTCTGACCTTCCTGACCGCTCAGACCTTTCTG 960
Qy 321 MetAspLeuGlyGlnPheLeuLeuPheCysHisIleSerSerHisHisHisGlyGlyMet 340
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 ATGGACCTGGGGCAGTTCCTGCTGTTTTGCCATATCTCTTCCCACCATCACGGAGGAATG 1020
Qy 341 GluAlaHisValArgValGluSerCysAlaGluGluProGlnLeuArgArgLysAlaAsp 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 GAGGCTCACGTCAGGGTGGAATCCTGTGCTGAGGAACCACAGCTGAGAAGAAAGGCTGAT 1080
Qy 361 GluGluGluAspTyrAspAspAsnLeuTyrAspSerAspMetAspValValArgLeuAsp 380
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 GAGGAAGAGGACTACGACGATAACCTGTATGACAGCGATATGGACGTCGTGCGCCTGGAC 1140
Qy 381 GlyAspAspValSerProPheIleGlnIleArgSerValAlaLysLysHisProLysThr 400
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 GGCGACGATGTCAGCCCTTTCATCCAGATCCGGTCTGTGGCCAAGAAACATCCAAAGACC 1200
Qy 401 TrpValHisTyrIleAlaAlaGluGluGluAspTrpAspTyrAlaProLeuValLeuAla 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1201 TGGGTCCACTACATCGCCGCTGAAGAGGAAGATTGGGACTATGCCCCCCTGGTGCTGGCT 1260
Qy 421 ProAspAspArgSerTyrLysSerGlnTyrLeuAsnAsnGlyProGlnArgIleGlyArg 440
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1261 CCTGACGATAGATCCTACAAAAGCCAGTATCTGAACAATGGGCCCCAGCGCATCGGACGG 1320
Qy 441 LysTyrLysLysValArgPheMetAlaTyrThrAspGluThrPheLysThrArgGluAla 460
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1321 AAGTACAAGAAAGTGAGGTTCATGGCCTATACCGACGAGACCTTTAAGACCAGAGAGGCT 1380
Qy 461 IleGlnHisGluSerGlyIleLeuGlyProLeuLeuTyrGlyGluValGlyAspThrLeu 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1381 ATCCAGCACGAATCCGGGATCCTGGGACCTCTGCTGTACGGCGAAGTGGGGGATACCCTG 1440
Qy 481 LeuIleIlePheLysAsnGlnAlaSerArgProTyrAsnIleTyrProHisGlyIleThr 500
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1441 CTGATCATCTTCAAGAACCAGGCCTCCAGGCCATACAATATCTATCCCCATGGCATCACC 1500
Qy 501 AspValArgProLeuTyrSerArgArgLeuProLysGlyValLysHisLeuLysAspPhe 520
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1501 GACGTGAGACCACTGTACAGCAGGAGACTGCCCAAGGGGGTCAAACACCTGAAGGATTTC 1560
Qy 521 ProIleLeuProGlyGluIlePheLysTyrLysTrpThrValThrValGluAspGlyPro 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1561 CCCATCCTGCCTGGAGAGATCTTTAAGTATAAATGGACCGTCACCGTGGAAGACGGGCCT 1620
Qy 541 ThrLysSerAspProArgCysLeuThrArgTyrTyrSerSerPheValAsnMetGluArg 560
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1621 ACCAAGTCCGATCCACGCTGCCTGACCCGGTACTATAGCTCTTTCGTGAACATGGAGAGA 1680
Qy 561 AspLeuAlaSerGlyLeuIleGlyProLeuLeuIleCysTyrLysGluSerValAspGln 580
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1681 GACCTGGCTAGCGGACTGATCGGACCCCTGCTGATCTGTTACAAAGAGAGCGTGGACCAG 1740
Qy 581 ArgGlyAsnGlnIleMetSerAspLysArgAsnValIleLeuPheSerValPheAspGlu 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1741 AGGGGCAACCAGATCATGTCTGATAAGAGAAATGTCATCCTGTTCTCCGTGTTTGACGAG 1800
Qy 601 AsnArgSerTrpTyrLeuThrGluAsnIleGlnArgPheLeuProAsnProAlaGlyVal 620
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1801 AACCGCAGCTGGTACCTGACCGAGAACATCCAGCGGTTCCTGCCAAATCCAGCTGGAGTG 1860
Qy 621 GlnLeuGluAspProGluPheGlnAlaSerAsnIleMetHisSerIleAsnGlyTyrVal 640
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1861 CAGCTGGAGGACCCAGAATTTCAGGCTTCCAACATCATGCATAGCATCAATGGCTACGTG 1920
Qy 641 PheAspSerLeuGlnLeuSerValCysLeuHisGluValAlaTyrTrpTyrIleLeuSer 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1921 TTCGATAGCCTGCAGCTGTCTGTCTGCCTGCACGAGGTGGCCTACTGGTATATCCTGTCC 1980
Qy 661 IleGlyAlaGlnThrAspPheLeuSerValPhePheSerGlyTyrThrPheLysHisLys 680
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1981 ATCGGCGCTCAGACCGACTTCCTGTCCGTGTTCTTTAGCGGGTACACCTTTAAGCATAAA 2040
Qy 681 MetValTyrGluAspThrLeuThrLeuPheProPheSerGlyGluThrValPheMetSer 700
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2041 ATGGTGTATGAGGATACCCTGACCCTGTTCCCCTTTTCTGGCGAGACCGTGTTCATGTCC 2100
Qy 701 MetGluAsnProGlyLeuTrpIleLeuGlyCysHisAsnSerAspPheArgAsnArgGly 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2101 ATGGAAAACCCTGGCCTGTGGATCCTGGGGTGCCACAACAGCGACTTCAGGAATAGAGGA 2160
Qy 721 MetThrAlaLeuLeuLysValSerSerCysAspLysAsnThrGlyAspTyrTyrGluAsp 740
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2161 ATGACCGCCCTGCTGAAAGTGTCCAGCTGTGATAAGAATACCGGCGATTACTATGAGGAC 2220
Qy 741 SerTyrGluAspIleSerAlaTyrLeuLeuSerLysAsnAsnAlaIleGluProArgSer 760
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2221 TCTTACGAAGATATCTCCGCTTATCTGCTGAGCAAGAACAATGCCATCGAGCCCAGGTCT 2280
Qy 761 PheSerGlnAsn------------------------------ProProValLeuLysArg 770
|||:::|||||| ||||||||||||:::|||
Db 2281 TTCGCTCAGAACTCCAGACCTCCAAGCGCTTCTGCTCCTAAGCCACCTGTGCTGAGAAGA 2340
Qy 771 HisGlnArgAspIleSerLeuProThrPheGlnProGluGluAspLysMetAspTyrAsp 790
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2341 CATCAGAGGGACATCTCCCTGCCTACCTTCCAGCCAGAGGAAGATAAAATGGACTACGAC 2400
Qy 791 AspIlePheSerThrGluThrLysGlyGluAspPheAspIleTyrGlyGluAspGluAsn 810
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2401 GATATCTTCAGCACCGAGACCAAGGGGGAAGATTTTGACATCTATGGAGAGGACGAAAAC 2460
Qy 811 GlnAspProArgSerPheGlnLysArgThrArgHisTyrPheIleAlaAlaValGluGln 830
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2461 CAGGATCCAAGATCCTTCCAGAAGAGAACCAGACACTACTTTATCGCCGCTGTGGAGCAG 2520
Qy 831 LeuTrpAspTyrGlyMetSerGluSerProArgAlaLeuArgAsnArgAlaGlnAsnGly 850
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2521 CTGTGGGACTATGGGATGTCCGAAAGCCCACGGGCCCTGAGGAACAGAGCTCAGAATGGA 2580
Qy 851 GluValProArgPheLysLysValValPheArgGluPheAlaAspGlySerPheThrGln 870
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2581 GAGGTGCCCCGCTTCAAGAAAGTCGTGTTCCGGGAGTTTGCCGACGGCAGCTTTACCCAG 2640
Qy 871 ProSerTyrArgGlyGluLeuAsnLysHisLeuGlyLeuLeuGlyProTyrIleArgAla 890
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2641 CCATCTTACAGGGGGGAGCTGAACAAGCATCTGGGGCTGCTGGGACCCTATATCAGAGCC 2700
Qy 891 GluValGluAspAsnIleMetValThrPheLysAsnGlnAlaSerArgProTyrSerPhe 910
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2701 GAGGTCGAAGATAACATCATGGTGACCTTCAAGAATCAGGCTTCTCGCCCCTACTCCTTT 2760
Qy 911 TyrSerSerLeuIleSerTyrProAspAspGlnGluGlnGlyAlaGluProArgHisAsn 930
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2761 TATTCTTCCCTGATCTCCTACCCTGACGATCAGGAGCAGGGCGCCGAACCTAGGCACAAC 2820
Qy 931 PheValGlnProAsnGluThrArgThrTyrPheTrpLysValGlnHisHisMetAlaPro 950
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2821 TTCGTGCAGCCAAATGAGACCAGAACCTACTTTTGGAAGGTGCAGCATCACATGGCTCCC 2880
Qy 951 ThrGluAspGluPheAspCysLysAlaTrpAlaTyrPheSerAspValAspLeuGluLys 970
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2881 ACCGAGGATGAATTCGACTGCAAAGCTTGGGCCTATTTTTCCGATGTCGACCTGGAGAAG 2940
Qy 971 AspValHisSerGlyLeuIleGlyProLeuLeuIleCysArgAlaAsnThrLeuAsnAla 990
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2941 GACGTGCATAGCGGCCTGATCGGGCCTCTGCTGATCTGTCGCGCCAACACCCTGAATGCT 3000
Qy 991 AlaHisGlyArgGlnValThrValGlnGluPheAlaLeuPhePheThrIlePheAspGlu 1010
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3001 GCTCACGGAAGACAGGTCACCGTGCAGGAGTTCGCTCTGTTCTTTACCATCTTTGACGAA 3060
Qy 1011 ThrLysSerTrpTyrPheThrGluAsnValGluArgAsnCysArgAlaProCysHisLeu 1030
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3061 ACCAAGAGCTGGTACTTCACCGAGAACGTGGAAAGGAATTGCAGAGCCCCCTGTCATCTG 3120
Qy 1031 GlnMetGluAspProThrLeuLysGluAsnTyrArgPheHisAlaIleAsnGlyTyrVal 1050
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3121 CAGATGGAGGACCCTACCCTGAAGGAAAACTACAGGTTCCACGCCATCAATGGATATGTC 3180
Qy 1051 MetAspThrLeuProGlyLeuValMetAlaGlnAsnGlnArgIleArgTrpTyrLeuLeu 1070
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3181 ATGGATACCCTGCCCGGCCTGGTCATGGCTCAGAACCAGCGCATCCGGTGGTACCTGCTG 3240
Qy 1071 SerMetGlySerAsnGluAsnIleHisSerIleHisPheSerGlyHisValPheSerVal 1090
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3241 TCTATGGGATCCAACGAGAATATCCATAGCATCCACTTCTCTGGCCATGTCTTTTCCGTG 3300
Qy 1091 ArgLysLysGluGluTyrLysMetAlaValTyrAsnLeuTyrProGlyValPheGluThr 1110
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3301 AGGAAGAAAGAGGAATACAAAATGGCCGTGTACAATCTGTATCCTGGGGTCTTCGAGACC 3360
Qy 1111 ValGluMetLeuProSerLysValGlyIleTrpArgIleGluCysLeuIleGlyGluHis 1130
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3361 GTGGAAATGCTGCCAAGCAAAGTGGGAATCTGGAGAATCGAGTGCCTGATCGGCGAACAC 3420
Qy 1131 LeuGlnAlaGlyMetSerThrThrPheLeuValTyrSerLysLysCysGlnThrProLeu 1150
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3421 CTGCAGGCCGGGATGAGCACCACCTTCCTGGTGTACTCTAAGAAATGTCAGACCCCACTG 3480
Qy 1151 GlyMetAlaSerGlyHisIleArgAspPheGlnIleThrAlaSerGlyGlnTyrGlyGln 1170
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3481 GGGATGGCCTCCGGACATATCCGCGACTTCCAGATCACCGCTAGCGGACAGTACGGACAG 3540
Qy 1171 TrpAlaProLysLeuAlaArgLeuHisTyrSerGlySerIleAsnAlaTrpSerThrLys 1190
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3541 TGGGCTCCAAAGCTGGCTAGACTGCACTATTCTGGCTCCATCAACGCCTGGTCTACCAAA 3600
Qy 1191 GluProPheSerTrpIleLysValAspLeuLeuAlaProMetIleIleHisGlyIleLys 1210
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3601 GAGCCATTCTCCTGGATCAAGGTGGACCTGCTGGCCCCCATGATCATCCACGGAATCAAA 3660
Qy 1211 ThrGlnGlyAlaArgGlnLysPheSerSerLeuTyrIleSerGlnPheIleIleMetTyr 1230
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3661 ACCCAGGGCGCTAGGCAGAAGTTCAGCTCTCTGTACATCTCCCAGTTTATCATCATGTAT 3720
Qy 1231 SerLeuAspGlyLysLysTrpGlnThrTyrArgGlyAsnSerThrGlyThrLeuMetVal 1250
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3721 AGCCTGGACGGGAAGAAATGGCAGACCTACAGAGGCAATTCCACCGGGACCCTGATGGTC 3780
Qy 1251 PhePheGlyAsnValAspSerSerGlyIleLysHisAsnIlePheAsnProProIleIle 1270
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3781 TTCTTTGGAAACGTGGATTCCAGCGGCATCAAGCACAACATCTTCAATCCACCCATCATC 3840
Qy 1271 AlaArgTyrIleArgLeuHisProThrHisTyrSerIleArgSerThrLeuArgMetGlu 1290
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3841 GCCCGCTACATCCGGCTGCATCCTACCCACTATAGCATCAGGTCTACCCTGAGAATGGAG 3900
Qy 1291 LeuMetGlyCysAspLeuAsnSerCysSerMetProLeuGlyMetGluSerLysAlaIle 1310
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3901 CTGATGGGATGCGACCTGAACAGCTGTTCTATGCCACTGGGCATGGAGTCCAAGGCTATC 3960
Qy 1311 SerAspAlaGlnIleThrAlaSerSerTyrPheThrAsnMetPheAlaThrTrpSerPro 1330
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3961 AGCGATGCCCAGATCACCGCTTCTTCCTACTTCACCAATATGTTTGCTACCTGGTCCCCA 4020
Qy 1331 SerLysAlaArgLeuHisLeuGlnGlyArgSerAsnAlaTrpArgProGlnValAsnAsn 1350
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4021 AGCAAGGCTAGACTGCACCTGCAGGGAAGATCCAACGCTTGGAGACCCCAGGTGAACAAT 4080
Qy 1351 ProLysGluTrpLeuGlnValAspPheGlnLysThrMetLysValThrGlyValThrThr 1370
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4081 CCTAAGGAGTGGCTGCAGGTCGACTTCCAGAAAACCATGAAGGTCACCGGGGTGACCACC 4140
Qy 1371 GlnGlyValLysSerLeuLeuThrSerMetTyrValLysGluPheLeuIleSerSerSer 1390
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4141 CAGGGAGTGAAATCTCTGCTGACCTCCATGTACGTCAAGGAGTTCCTGATCAGCTCTTCC 4200
Qy 1391 GlnAspGlyHisGlnTrpThrLeuPhePheGlnAsnGlyLysValLysValPheGlnGly 1410
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4201 CAGGACGGCCACCAGTGGACCCTGTTCTTTCAGAACGGCAAGGTCAAAGTGTTCCAGGGG 4260
Qy 1411 AsnGlnAspSerPheThrProValValAsnSerLeuAspProProLeuLeuThrArgTyr 1430
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4261 AATCAGGACTCTTTTACCCCCGTCGTGAACTCCCTGGATCCTCCACTGCTGACCAGGTAC 4320
Qy 1431 LeuArgIleHisProGlnSerTrpValHisGlnIleAlaLeuArgMetGluValLeuGly 1450
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4321 CTGAGAATCCATCCTCAGAGCTGGGTGCACCAGATCGCTCTGAGAATGGAGGTCCTGGGA 4380
Qy 1451 CysGluAlaGlnAspLeuTyr 1457
|||||||||||||||||||||
Db 4381 TGCGAAGCTCAGGACCTGTAT 4401
Claim(s) 1 and 3-5 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Doering et al. (U.S. Patent No. 10,898,588 B2).
Doering et al. (U.S. Patent 10,898,588 B2) disclose an isolated polynucleotide, e.g. at least 90% identical to SEQ ID NO: 12 (claim 1); SEQ ID NO: 12 comprises a sequence having at least 99.3% sequence identity to SEQ ID NO: 20. A method of treating a factor VIII deficiency (hemophilia A) comprising administering to a subject in need thereof a composition comprising a therapeutically effective amount of a vector, wherein said polynucleotide sequence having at least 99.3% sequence identity to SEQ ID NO: 20. A composition comprising the vector and a pharmaceutically acceptable carrier. The composition, wherein the composition treats a factor VIII deficiency (see alignment below of SEQ ID NO: 20 of the pending application (identified as Qy) and SEQ ID NO: 12 of the issued patent (identified as Db) and claims 1-18 of issued patent). Claim 1 of the pending application claims a polypeptide comprising a nucleotide sequence.
Alignment Scores:
Length: 4404
Score: 7773.00 Matches: 1455
Percent Similarity: 99.3% Conservative: 2
Best Local Similarity: 99.2% Mismatches: 0
Query Match: 99.7% Indels: 10
Gaps: 1
US-17/632,222 (SEQ ID NO: 20) (1-1457) x US-16/058,808 (SEQ ID NO:12) (1-4404)
Qy 1 MetGlnLeuGluLeuSerThrCysValPheLeuCysLeuLeuProLeuGlyPheSerAla 20
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ATGCAGCTGGAACTGTCTACCTGTGTGTTTCTGTGTCTGCTGCCTCTGGGGTTTTCTGCT 60
Qy 21 IleArgArgTyrTyrLeuGlyAlaValGluLeuSerTrpAspTyrArgGlnSerGluLeu 40
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ATCCGCCGCTACTATCTGGGAGCCGTGGAGCTGTCCTGGGACTACAGGCAGAGCGAGCTG 120
Qy 41 LeuArgGluLeuHisValAspThrArgPheProAlaThrAlaProGlyAlaLeuProLeu 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 CTGAGAGAACTGCACGTGGATACCAGATTCCCAGCTACCGCTCCAGGAGCTCTGCCTCTG 180
Qy 61 GlyProSerValLeuTyrLysLysThrValPheValGluPheThrAspGlnLeuPheSer 80
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GGCCCATCCGTGCTGTACAAGAAAACCGTCTTCGTGGAGTTTACCGACCAGCTGTTCAGC 240
Qy 81 ValAlaArgProArgProProTrpMetGlyLeuLeuGlyProThrIleGlnAlaGluVal 100
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GTGGCCAGGCCAAGACCACCTTGGATGGGACTGCTGGGACCAACCATCCAGGCTGAGGTG 300
Qy 101 TyrAspThrValValValThrLeuLysAsnMetAlaSerHisProValSerLeuHisAla 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 TACGATACCGTGGTCGTGACCCTGAAAAACATGGCCTCCCATCCCGTGAGCCTGCACGCT 360
Qy 121 ValGlyValSerPheTrpLysSerSerGluGlyAlaGluTyrGluAspHisThrSerGln 140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 GTCGGGGTGTCCTTCTGGAAGTCCAGCGAGGGAGCCGAGTACGAAGACCATACCTCCCAG 420
Qy 141 ArgGluLysGluAspAspLysValLeuProGlyLysSerGlnThrTyrValTrpGlnVal 160
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 CGCGAGAAAGAAGACGATAAGGTGCTGCCTGGCAAAAGCCAGACCTATGTCTGGCAGGTG 480
Qy 161 LeuLysGluAsnGlyProThrAlaSerAspProProCysLeuThrTyrSerTyrLeuSer 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 CTGAAGGAGAACGGACCAACCGCTAGCGACCCACCATGCCTGACCTACTCTTATCTGTCC 540
Qy 181 HisValAspLeuValLysAspLeuAsnSerGlyLeuIleGlyAlaLeuLeuValCysArg 200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 CACGTCGATCTGGTGAAGGACCTGAATTCCGGACTGATCGGAGCTCTGCTGGTGTGTAGA 600
Qy 201 GluGlySerLeuThrArgGluArgThrGlnAsnLeuHisGluPheValLeuLeuPheAla 220
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 GAGGGAAGCCTGACCAGAGAAAGAACCCAGAACCTGCATGAGTTCGTCCTGCTGTTCGCC 660
Qy 221 ValPheAspGluGlyLysSerTrpHisSerAlaArgAsnAspSerTrpThrArgAlaMet 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 GTGTTTGACGAAGGGAAGAGCTGGCACTCTGCCCGCAATGACTCCTGGACCAGAGCTATG 720
Qy 241 AspProAlaProAlaArgAlaGlnProAlaMetHisThrValAsnGlyTyrValAsnArg 260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 GATCCAGCTCCTGCTAGAGCTCAGCCTGCTATGCACACCGTCAACGGCTACGTGAATCGG 780
Qy 261 SerLeuProGlyLeuIleGlyCysHisLysLysSerValTyrTrpHisValIleGlyMet 280
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 TCTCTGCCAGGACTGATCGGCTGCCATAAGAAAAGCGTCTATTGGCACGTGATCGGAATG 840
Qy 281 GlyThrSerProGluValHisSerIlePheLeuGluGlyHisThrPheLeuValArgHis 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 GGCACCAGCCCCGAGGTGCATTCTATCTTCCTGGAAGGCCACACCTTTCTGGTCAGGCAC 900
Qy 301 HisArgGlnAlaSerLeuGluIleSerProLeuThrPheLeuThrAlaGlnThrPheLeu 320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 CATAGACAGGCCTCTCTGGAGATCTCCCCTCTGACCTTCCTGACCGCTCAGACCTTTCTG 960
Qy 321 MetAspLeuGlyGlnPheLeuLeuPheCysHisIleSerSerHisHisHisGlyGlyMet 340
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 ATGGACCTGGGGCAGTTCCTGCTGTTTTGCCATATCTCTTCCCACCATCACGGAGGAATG 1020
Qy 341 GluAlaHisValArgValGluSerCysAlaGluGluProGlnLeuArgArgLysAlaAsp 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 GAGGCTCACGTCAGGGTGGAATCCTGTGCTGAGGAACCACAGCTGAGAAGAAAGGCTGAT 1080
Qy 361 GluGluGluAspTyrAspAspAsnLeuTyrAspSerAspMetAspValValArgLeuAsp 380
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 GAGGAAGAGGACTACGACGATAACCTGTATGACAGCGATATGGACGTCGTGCGCCTGGAC 1140
Qy 381 GlyAspAspValSerProPheIleGlnIleArgSerValAlaLysLysHisProLysThr 400
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 GGCGACGATGTCAGCCCTTTCATCCAGATCCGGTCTGTGGCCAAGAAACATCCAAAGACC 1200
Qy 401 TrpValHisTyrIleAlaAlaGluGluGluAspTrpAspTyrAlaProLeuValLeuAla 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1201 TGGGTCCACTACATCGCCGCTGAAGAGGAAGATTGGGACTATGCCCCCCTGGTGCTGGCT 1260
Qy 421 ProAspAspArgSerTyrLysSerGlnTyrLeuAsnAsnGlyProGlnArgIleGlyArg 440
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1261 CCTGACGATAGATCCTACAAAAGCCAGTATCTGAACAATGGGCCCCAGCGCATCGGACGG 1320
Qy 441 LysTyrLysLysValArgPheMetAlaTyrThrAspGluThrPheLysThrArgGluAla 460
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1321 AAGTACAAGAAAGTGAGGTTCATGGCCTATACCGACGAGACCTTTAAGACCAGAGAGGCT 1380
Qy 461 IleGlnHisGluSerGlyIleLeuGlyProLeuLeuTyrGlyGluValGlyAspThrLeu 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1381 ATCCAGCACGAATCCGGGATCCTGGGACCTCTGCTGTACGGCGAAGTGGGGGATACCCTG 1440
Qy 481 LeuIleIlePheLysAsnGlnAlaSerArgProTyrAsnIleTyrProHisGlyIleThr 500
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1441 CTGATCATCTTCAAGAACCAGGCCTCCAGGCCATACAATATCTATCCCCATGGCATCACC 1500
Qy 501 AspValArgProLeuTyrSerArgArgLeuProLysGlyValLysHisLeuLysAspPhe 520
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1501 GACGTGAGACCACTGTACAGCAGGAGACTGCCCAAGGGGGTCAAACACCTGAAGGATTTC 1560
Qy 521 ProIleLeuProGlyGluIlePheLysTyrLysTrpThrValThrValGluAspGlyPro 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1561 CCCATCCTGCCTGGAGAGATCTTTAAGTATAAATGGACCGTCACCGTGGAAGACGGGCCT 1620
Qy 541 ThrLysSerAspProArgCysLeuThrArgTyrTyrSerSerPheValAsnMetGluArg 560
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1621 ACCAAGTCCGATCCACGCTGCCTGACCCGGTACTATAGCTCTTTCGTGAACATGGAGAGA 1680
Qy 561 AspLeuAlaSerGlyLeuIleGlyProLeuLeuIleCysTyrLysGluSerValAspGln 580
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1681 GACCTGGCTAGCGGACTGATCGGACCCCTGCTGATCTGTTACAAAGAGAGCGTGGACCAG 1740
Qy 581 ArgGlyAsnGlnIleMetSerAspLysArgAsnValIleLeuPheSerValPheAspGlu 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1741 AGGGGCAACCAGATCATGTCTGATAAGAGAAATGTCATCCTGTTCTCCGTGTTTGACGAG 1800
Qy 601 AsnArgSerTrpTyrLeuThrGluAsnIleGlnArgPheLeuProAsnProAlaGlyVal 620
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1801 AACCGCAGCTGGTACCTGACCGAGAACATCCAGCGGTTCCTGCCAAATCCAGCTGGAGTG 1860
Qy 621 GlnLeuGluAspProGluPheGlnAlaSerAsnIleMetHisSerIleAsnGlyTyrVal 640
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1861 CAGCTGGAGGACCCAGAATTTCAGGCTTCCAACATCATGCATAGCATCAATGGCTACGTG 1920
Qy 641 PheAspSerLeuGlnLeuSerValCysLeuHisGluValAlaTyrTrpTyrIleLeuSer 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1921 TTCGATAGCCTGCAGCTGTCTGTCTGCCTGCACGAGGTGGCCTACTGGTATATCCTGTCC 1980
Qy 661 IleGlyAlaGlnThrAspPheLeuSerValPhePheSerGlyTyrThrPheLysHisLys 680
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1981 ATCGGCGCTCAGACCGACTTCCTGTCCGTGTTCTTTAGCGGGTACACCTTTAAGCATAAA 2040
Qy 681 MetValTyrGluAspThrLeuThrLeuPheProPheSerGlyGluThrValPheMetSer 700
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2041 ATGGTGTATGAGGATACCCTGACCCTGTTCCCCTTTTCTGGCGAGACCGTGTTCATGTCC 2100
Qy 701 MetGluAsnProGlyLeuTrpIleLeuGlyCysHisAsnSerAspPheArgAsnArgGly 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2101 ATGGAAAACCCTGGCCTGTGGATCCTGGGGTGCCACAACAGCGACTTCAGGAATAGAGGA 2160
Qy 721 MetThrAlaLeuLeuLysValSerSerCysAspLysAsnThrGlyAspTyrTyrGluAsp 740
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2161 ATGACCGCCCTGCTGAAAGTGTCCAGCTGTGATAAGAATACCGGCGATTACTATGAGGAC 2220
Qy 741 SerTyrGluAspIleSerAlaTyrLeuLeuSerLysAsnAsnAlaIleGluProArgSer 760
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2221 TCTTACGAAGATATCTCCGCTTATCTGCTGAGCAAGAACAATGCCATCGAGCCCAGGTCT 2280
Qy 761 PheSerGlnAsn------------------------------ProProValLeuLysArg 770
|||:::|||||| ||||||||||||:::|||
Db 2281 TTCGCTCAGAACTCCAGACCTCCAAGCGCTTCTGCTCCTAAGCCACCTGTGCTGAGAAGA 2340
Qy 771 HisGlnArgAspIleSerLeuProThrPheGlnProGluGluAspLysMetAspTyrAsp 790
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2341 CATCAGAGGGACATCTCCCTGCCTACCTTCCAGCCAGAGGAAGATAAAATGGACTACGAC 2400
Qy 791 AspIlePheSerThrGluThrLysGlyGluAspPheAspIleTyrGlyGluAspGluAsn 810
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2401 GATATCTTCAGCACCGAGACCAAGGGGGAAGATTTTGACATCTATGGAGAGGACGAAAAC 2460
Qy 811 GlnAspProArgSerPheGlnLysArgThrArgHisTyrPheIleAlaAlaValGluGln 830
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2461 CAGGATCCAAGATCCTTCCAGAAGAGAACCAGACACTACTTTATCGCCGCTGTGGAGCAG 2520
Qy 831 LeuTrpAspTyrGlyMetSerGluSerProArgAlaLeuArgAsnArgAlaGlnAsnGly 850
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2521 CTGTGGGACTATGGGATGTCCGAAAGCCCACGGGCCCTGAGGAACAGAGCTCAGAATGGA 2580
Qy 851 GluValProArgPheLysLysValValPheArgGluPheAlaAspGlySerPheThrGln 870
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2581 GAGGTGCCCCGCTTCAAGAAAGTCGTGTTCCGGGAGTTTGCCGACGGCAGCTTTACCCAG 2640
Qy 871 ProSerTyrArgGlyGluLeuAsnLysHisLeuGlyLeuLeuGlyProTyrIleArgAla 890
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2641 CCATCTTACAGGGGGGAGCTGAACAAGCATCTGGGGCTGCTGGGACCCTATATCAGAGCC 2700
Qy 891 GluValGluAspAsnIleMetValThrPheLysAsnGlnAlaSerArgProTyrSerPhe 910
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2701 GAGGTCGAAGATAACATCATGGTGACCTTCAAGAATCAGGCTTCTCGCCCCTACTCCTTT 2760
Qy 911 TyrSerSerLeuIleSerTyrProAspAspGlnGluGlnGlyAlaGluProArgHisAsn 930
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2761 TATTCTTCCCTGATCTCCTACCCTGACGATCAGGAGCAGGGCGCCGAACCTAGGCACAAC 2820
Qy 931 PheValGlnProAsnGluThrArgThrTyrPheTrpLysValGlnHisHisMetAlaPro 950
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2821 TTCGTGCAGCCAAATGAGACCAGAACCTACTTTTGGAAGGTGCAGCATCACATGGCTCCC 2880
Qy 951 ThrGluAspGluPheAspCysLysAlaTrpAlaTyrPheSerAspValAspLeuGluLys 970
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2881 ACCGAGGATGAATTCGACTGCAAAGCTTGGGCCTATTTTTCCGATGTCGACCTGGAGAAG 2940
Qy 971 AspValHisSerGlyLeuIleGlyProLeuLeuIleCysArgAlaAsnThrLeuAsnAla 990
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2941 GACGTGCATAGCGGCCTGATCGGGCCTCTGCTGATCTGTCGCGCCAACACCCTGAATGCT 3000
Qy 991 AlaHisGlyArgGlnValThrValGlnGluPheAlaLeuPhePheThrIlePheAspGlu 1010
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3001 GCTCACGGAAGACAGGTCACCGTGCAGGAGTTCGCTCTGTTCTTTACCATCTTTGACGAA 3060
Qy 1011 ThrLysSerTrpTyrPheThrGluAsnValGluArgAsnCysArgAlaProCysHisLeu 1030
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3061 ACCAAGAGCTGGTACTTCACCGAGAACGTGGAAAGGAATTGCAGAGCCCCCTGTCATCTG 3120
Qy 1031 GlnMetGluAspProThrLeuLysGluAsnTyrArgPheHisAlaIleAsnGlyTyrVal 1050
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3121 CAGATGGAGGACCCTACCCTGAAGGAAAACTACAGGTTCCACGCCATCAATGGATATGTC 3180
Qy 1051 MetAspThrLeuProGlyLeuValMetAlaGlnAsnGlnArgIleArgTrpTyrLeuLeu 1070
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3181 ATGGATACCCTGCCCGGCCTGGTCATGGCTCAGAACCAGCGCATCCGGTGGTACCTGCTG 3240
Qy 1071 SerMetGlySerAsnGluAsnIleHisSerIleHisPheSerGlyHisValPheSerVal 1090
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3241 TCTATGGGATCCAACGAGAATATCCATAGCATCCACTTCTCTGGCCATGTCTTTTCCGTG 3300
Qy 1091 ArgLysLysGluGluTyrLysMetAlaValTyrAsnLeuTyrProGlyValPheGluThr 1110
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3301 AGGAAGAAAGAGGAATACAAAATGGCCGTGTACAATCTGTATCCTGGGGTCTTCGAGACC 3360
Qy 1111 ValGluMetLeuProSerLysValGlyIleTrpArgIleGluCysLeuIleGlyGluHis 1130
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3361 GTGGAAATGCTGCCAAGCAAAGTGGGAATCTGGAGAATCGAGTGCCTGATCGGCGAACAC 3420
Qy 1131 LeuGlnAlaGlyMetSerThrThrPheLeuValTyrSerLysLysCysGlnThrProLeu 1150
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3421 CTGCAGGCCGGGATGAGCACCACCTTCCTGGTGTACTCTAAGAAATGTCAGACCCCACTG 3480
Qy 1151 GlyMetAlaSerGlyHisIleArgAspPheGlnIleThrAlaSerGlyGlnTyrGlyGln 1170
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3481 GGGATGGCCTCCGGACATATCCGCGACTTCCAGATCACCGCTAGCGGACAGTACGGACAG 3540
Qy 1171 TrpAlaProLysLeuAlaArgLeuHisTyrSerGlySerIleAsnAlaTrpSerThrLys 1190
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3541 TGGGCTCCAAAGCTGGCTAGACTGCACTATTCTGGCTCCATCAACGCCTGGTCTACCAAA 3600
Qy 1191 GluProPheSerTrpIleLysValAspLeuLeuAlaProMetIleIleHisGlyIleLys 1210
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3601 GAGCCATTCTCCTGGATCAAGGTGGACCTGCTGGCCCCCATGATCATCCACGGAATCAAA 3660
Qy 1211 ThrGlnGlyAlaArgGlnLysPheSerSerLeuTyrIleSerGlnPheIleIleMetTyr 1230
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3661 ACCCAGGGCGCTAGGCAGAAGTTCAGCTCTCTGTACATCTCCCAGTTTATCATCATGTAT 3720
Qy 1231 SerLeuAspGlyLysLysTrpGlnThrTyrArgGlyAsnSerThrGlyThrLeuMetVal 1250
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3721 AGCCTGGACGGGAAGAAATGGCAGACCTACAGAGGCAATTCCACCGGGACCCTGATGGTC 3780
Qy 1251 PhePheGlyAsnValAspSerSerGlyIleLysHisAsnIlePheAsnProProIleIle 1270
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3781 TTCTTTGGAAACGTGGATTCCAGCGGCATCAAGCACAACATCTTCAATCCACCCATCATC 3840
Qy 1271 AlaArgTyrIleArgLeuHisProThrHisTyrSerIleArgSerThrLeuArgMetGlu 1290
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3841 GCCCGCTACATCCGGCTGCATCCTACCCACTATAGCATCAGGTCTACCCTGAGAATGGAG 3900
Qy 1291 LeuMetGlyCysAspLeuAsnSerCysSerMetProLeuGlyMetGluSerLysAlaIle 1310
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3901 CTGATGGGATGCGACCTGAACAGCTGTTCTATGCCACTGGGCATGGAGTCCAAGGCTATC 3960
Qy 1311 SerAspAlaGlnIleThrAlaSerSerTyrPheThrAsnMetPheAlaThrTrpSerPro 1330
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3961 AGCGATGCCCAGATCACCGCTTCTTCCTACTTCACCAATATGTTTGCTACCTGGTCCCCA 4020
Qy 1331 SerLysAlaArgLeuHisLeuGlnGlyArgSerAsnAlaTrpArgProGlnValAsnAsn 1350
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4021 AGCAAGGCTAGACTGCACCTGCAGGGAAGATCCAACGCTTGGAGACCCCAGGTGAACAAT 4080
Qy 1351 ProLysGluTrpLeuGlnValAspPheGlnLysThrMetLysValThrGlyValThrThr 1370
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4081 CCTAAGGAGTGGCTGCAGGTCGACTTCCAGAAAACCATGAAGGTCACCGGGGTGACCACC 4140
Qy 1371 GlnGlyValLysSerLeuLeuThrSerMetTyrValLysGluPheLeuIleSerSerSer 1390
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4141 CAGGGAGTGAAATCTCTGCTGACCTCCATGTACGTCAAGGAGTTCCTGATCAGCTCTTCC 4200
Qy 1391 GlnAspGlyHisGlnTrpThrLeuPhePheGlnAsnGlyLysValLysValPheGlnGly 1410
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4201 CAGGACGGCCACCAGTGGACCCTGTTCTTTCAGAACGGCAAGGTCAAAGTGTTCCAGGGG 4260
Qy 1411 AsnGlnAspSerPheThrProValValAsnSerLeuAspProProLeuLeuThrArgTyr 1430
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4261 AATCAGGACTCTTTTACCCCCGTCGTGAACTCCCTGGATCCTCCACTGCTGACCAGGTAC 4320
Qy 1431 LeuArgIleHisProGlnSerTrpValHisGlnIleAlaLeuArgMetGluValLeuGly 1450
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4321 CTGAGAATCCATCCTCAGAGCTGGGTGCACCAGATCGCTCTGAGAATGGAGGTCCTGGGA 4380
Qy 1451 CysGluAlaGlnAspLeuTyr 1457
|||||||||||||||||||||
Db 4381 TGCGAAGCTCAGGACCTGTAT 4401
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Doering et al. (U.S. Patent No. 10,058,624 B2) in view of Lollar (WO 2003/031598 A2).
Doering et al. (U.S. Patent 10,058,624 B2) disclose an isolated polynucleotide, e.g. at least 90% identical to SEQ ID NO: 12 (see claim 25); SEQ ID NO: 12 comprises a sequence having at least 99.3% sequence identity to SEQ ID NO: 20. A method of treating a factor VIII deficiency (hemophilia A) comprising administering to a subject in need thereof a composition comprising a therapeutically effective amount of a vector, wherein said polynucleotide sequence having at least 99.3% sequence identity to SEQ ID NO: 20. A composition comprising the vector and a pharmaceutically acceptable carrier. The composition, wherein the composition treats a factor VIII deficiency (see alignment below of SEQ ID NO: 20 of the pending application (identified as Qy) and SEQ ID NO: 12 of the issued patent (identified as Db) (claims 1 and 20-27)). Claim 1 of the pending application claims a polypeptide comprising a nucleotide sequence.
Alignment Scores:
Length: 4404
Score: 7773.00 Matches: 1455
Percent Similarity: 99.3% Conservative: 2
Best Local Similarity: 99.2% Mismatches: 0
Query Match: 99.7% Indels: 10
Gaps: 1
US-17/632,222 (SEQ ID NO: 20) (1-1457) x US-15/128,912 (SEQ ID NO:12) (1-4404)
Doering et al. does not disclose the polypeptides of SEQ ID NO; 15-21 as currently claimed. However, Lollar (WO 2003/031598 A2) disclose an isolated polypeptide comprising an amino acid sequence having at least 99.7% sequence identity to SEQ ID NO: 19. A method of increasing the level of expression of a factor VIII polypeptide in a cell comprising: a) introducing into said cell a nucleic acid molecule comprising a nucleotide sequence having at least 99.7% sequence identity to SEQ ID NO: 18, wherein said sequence encodes said factor VIII polypeptide and said factor VIII polypeptide is characterized by high expression; and b) culturing said cell under conditions that allow expression of said nucleic acid molecule. The method, wherein said nucleic acid molecule comprises a nucleotid a nucleotide sequence comprising the sequence set forth in SEQ ID NO: 18. The method, further comprising isolating said polypeptide. The method, further comprising isolating said polypeptide. A method of treating a factor VIII deficiency comprising administering to a subject in need thereof a composition comprising a therapeutically effective amount of a polypeptide, wherein said polypeptide comprises an amino acid sequence having at least 99.7% sequence identity to SEQ ID NO: 19 and said polypeptide is characterized by high-level expression. An isolated polypeptide comprising an amino acid sequence having at least 99.7% sequence identity to SEQ ID NO: 19, wherein said polypeptide is characterized by high-level expression as compared to a corresponding human factor VIII polypeptide expressed under the same conditions. A composition comprising a polypeptide and a pharmaceutically acceptable carrier. The composition, wherein the composition treats a factor VIII deficiency (see alignment in SCORE file 20260626_152525_us-17-632-222-19.rnpm, result #1, and claims 1-26 of WO 2003/031598).
Furthermore, the variability of amino acids in particular positions in SEQ ID NO: 19 of the currently claimed factor VIII polypeptide sequences in the instant application are disclosed in corresponding WO published WO patent document SEQ ID NO: sequences that have factor VIII activity, so that it would have been obvious to the person having ordinary skill in the art to arrive at SEQ ID NOs of the pending application that would result in 100% identity with factor VIII polypeptides with similar functional activity, therefore claims 2, and 6-8 are also rejected.
It would have been obvious to the person having ordinary skill in the art to use the modified factor VIII polypeptide as claimed as SEQ ID NO: 15-21, because the modifications were known in the art as disclosed by Lollar with particular amino acids disclosed at particular residues in an active factor VIII polypeptide used for blood clotting.
Conclusion
No claims are allowed.
Art not relied upon US Patent 6,818439 (SEQ ID NO: 47) and 9,050,318 (SEQ ID NO: 2) disclosing polypeptides with 99.9% identity with the polynucleotide of SEQ ID NO: 12 encoding modified factor VIII polypeptides.
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.
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/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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