DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7, 19-24, 37, 38, 59, and 69 in the reply filed on October 13, 2025 is acknowledged. Claims 1-7, 19-24, 37, 38, 59, and 69 will be examined.
Claim Objections
Claim 1 is objected to because of the following informality: “corresponding to” should be “comprising”.
Claim 2 is objected to because of the following informality: “comprising a polypeptide sequence having at least 75%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or more sequence identity to the reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 2, or to the reference sequence corresponding to SEQ ID NO: 2” should be “wherein the polypeptide sequence having at least 75%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or more sequence identity to the reference sequence comprises residues 12 to 687 of SEQ ID NO: 2, or to the reference sequence comprising SEQ ID NO: 2”.
Claim 3 or 19 or 20 is objected to because of the following informality: “comprising a polypeptide sequence having at least 75%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or more sequence identity to the reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to the reference sequence corresponding to SEQ ID NO: 24, 94, or 352” should be “wherein the polypeptide sequence having at least 75%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or more sequence identity to the reference sequence comprises residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to the reference sequence comprising SEQ ID NO: 24, 94, or 352”.
Claim 59 or 69 is objected to because of the following informality: “at least one recombinant reverse transcriptase of claim 1” should be “at least the recombinant reverse transcriptase of claim 1”.
Appropriate correction is required.
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.
Written Description
Claims 1-7, 19-24, 37, 38, 59, and 69 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is referred to the interim guidelines on written description published on December 21, 1999 in the Federal Register at Volume 64, Number 244, pp.71427-71440.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111 (Fed. Cir. 1991), clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” Vas-Cath Inc. v. Mahurkar, 19USPQ2d at 1117. The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed”. Vas-Cath Inc. v. Mahurkar, 19USPQ2d at 1116.
The specification provides adequate written description for SEQ ID NOs: 1 and 2 which are wild type of a reverse transcriptase cDNA and its protein sequence and SEQ ID NOs: 3-566 which are mutants of SEQ ID NOs:1 and 2 wherein the mutants of SEQ ID NO. 2 have 687 amino acids and 1 to 15 point mutations (see Tables 4.1, 5.1, 6. 1 and 7.1 of US 2023/183790 A1, which is US publication of this instant case). However, the specification fails to adequately describe: (1) any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 2, 24, 94, or 352, or to a reference sequence corresponding to SEQ ID NO: 2, 24, 94, or 352, wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 2, 24, 94, or 352, or to the reference sequence corresponding to SEQ ID NO: 2, 24, 94, or 352 as recited in claims 1-3, 19, and 20; (2) any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 2, or to a reference sequence corresponding to SEQ ID NO: 2 wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 2, or to the reference sequence corresponding to SEQ ID NO: 2, the polypeptide sequence comprises at least a substitution at amino acid position 18, 25, 49, 63, 68, 69, 72, 74, 78, 81, 83, 84, 85, 89, 90, 92, 94, 98, 102, 113, 114, 118, 119, 129, 130, 132, 134, 163, 167, 171, 173, 178, 196, 199, 205, 209, 210, 212, 216, 242, 258, 260, 261, 266, 294, 297,298, 300, 303, 305, 307, 308, 309, 310, 311, 314, 317, 319, 321, 329, 331, 333, 338, 342, 343,349, 356, 370, 403, 444, 447, 454, 464, 465, 466, 474, 479, 508, 509, 519, 536, 537, 554, 574, 576, 583, 595, 598, 606, 638, 639, or 662, or combinations thereof, wherein the amino acid positions are relative to the reference sequence of SEQ ID NO: 2 as recited in claims 4 and 6; (3) any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 2, or to a reference sequence corresponding to SEQ ID NO: 2 wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 2, or to the reference sequence corresponding to SEQ ID NO: 2, the polypeptide sequence comprises at least a substitution 18E, 25E, 49G, 63L/P, 68S, 69R, 72M,74K/M/P, 78V, 81K, 83E/A/C/R/W, 84N, 85R, 89A/M, 901, 92T, 94L, 98S, 102C, 113G/T, 114G/K, 118R, 119Y, 129L, 130R/S, 132F, 134F/P, 163P, 167Y, 171L, 173A, 178L, 196C/H, 199L, 205M, 209A, 210L, 212K/N/V, 216R, 242A, 258T, 260G, 261N, 266V, 294Q, 297W, 298E/R, 3001, 303G/Q, 305P/S, 307K/N, 308G, 309E/P/T, 310R, 311A/I/P, 314A/K/M, 317C, 319C/G/S, 321A, 329S, 331E, 333V, 338V, 342W, 343A/V, 349G, 356P, 370G, 403H, 444L, 447G/L/R, 454A, 464L, 465S, 466K, 474A, 479D, 508L, 509E, 519P, 536E/A/N, 537W, 554T, 574D/Q, 576I, 583K, 595N, 598S, 606K/Q, 638H, 639H, or 662R, or combinations thereof, wherein the amino acid positions are relative to the reference sequence of SEQ ID NO: 2 as recited in claims 5 and 7; (4) any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to a reference sequence corresponding to SEQ ID NO: 2 wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to the reference sequence corresponding to SEQ ID NO: 24, 94, or 352, the polypeptide sequence comprises at least a substitution at amino acid position 18, 25, 49, 63, 68, 69, 72, 74, 78, 81, 83, 84, 85, 89, 90, 92, 94, 98, 102, 113, 114, 118, 119, 129, 130, 132, 134, 163, 167, 171, 173, 178, 196, 199, 205, 209, 210, 212, 216, 242, 258, 260, 261, 266, 294, 297, 298, 300, 303, 305, 307, 308, 309, 310, 311, 314, 317, 319, 321, 329, 331, 333, 338, 342, 343,349, 356, 370, 403, 444, 447, 454, 464, 465, 466, 474, 479, 508, 509, 519, 536, 537, 554, 574, 576, 583, 595, 598, 606, 638, 639, or 662, or combinations thereof, wherein the amino acid positions are relative to the reference sequence of SEQ ID NO: 24, 94, or 352 as recited in claims 21 and 23; (5) any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to a reference sequence corresponding to SEQ ID NO: 24, 94, or 352, wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to the reference sequence corresponding to SEQ ID NO: 24, 94, or 352, the polypeptide sequence comprises at least a substitution 18E, 25E, 49G, 63L/P, 68S, 69R, 72M,74K/M/P, 78V, 81K, 83E/A/C/R/W, 84N, 85R, 89A/M, 901, 92T, 94L, 98S, 102C, 113G/T, 114G/K, 118R, 119Y, 129L, 130R/S, 132F, 134F/P, 163P, 167Y, 171L, 173A, 178L, 196C/H, 199L, 205M, 209A, 210L, 212K/N/V, 216R, 242A, 258T, 260G, 261N, 266V, 294Q, 297W, 298E/R, 3001, 303G/Q, 305P/S, 307K/N, 308G, 309E/P/T, 310R, 311A/I/P, 314A/K/M, 317C, 319C/G/S, 321A, 329S, 331E, 333V, 338V, 342W, 343A/V, 349G, 356P, 370G, 403H, 444L, 447G/L/R, 454A, 464L, 465S, 466K, 474A, 479D, 508L, 509E, 519P, 536E/A/N, 537W, 554T, 574D/Q, 576I, 583K, 595N, 598S, 606K/Q, 638H, 639H, or 662R, or combinations thereof, wherein the amino acid positions are relative to the reference sequence of SEQ ID NO: 24, 94, or 352 as recited in claims 22 and 24; (6) any kind of recombinant reverse transcriptase protein comprising a polypeptide sequence comprising residues 12 to 687 of SEQ ID NO: 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90, 92, 94, 96, 98, 100, 102, 104, 106, 108, 110, 112, 114, 116, 118, 120, 122, 124, 126, 128, 130, 132, 134, 136, 138, 140, 142, 144, 146, 148, 150, 152, 154, 156, 158, 160, 162, 164, 166, 168, 170, 172, 174, 176, 178, 180, 182, 184, 186, 188, 190, 192, 194, 196, 198, 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 288, 290, 292, 294, 296, 298, 300, 302, 304, 306, 308, 310, 312, 314, 316, 318, 320, 322, 324, 326, 328, 330, 332, 334, 336, 338, 340, 342, 344, 346, 348, 350, 352, 354, 356, 358, 360, 362, 364, 366, 368, 370, 372, 374, 376, 378, 380, 382, 384, 386, 388, 390, 392, 394, 396, 398, 400, 402, 404, 406, 408, 410, 412, 414, 416, 418, 420, 422, 424, 426, 428, 430, 432, 434, 436, 438, 440, 442, 444, 446, 448, 450, 452, 454, 456. 458, 460. 462, 464, 466, 468, 470, 472, 474, 476, 478, 480, 482, 484, 486, 488, 490, 492, 494, 496, 498, 500, 502, 504, 506, 508, 510, 512, 514, 516, 518, 520, 522, 524, 526, 528, 530, 532, 534, 536, 538, 540, 542, 544, 546, 548, 550, 552, 554, 556, 558, 560, 562, 564, or 566, wherein the polypeptide sequence optionally has 1, 2, 3, 4, 5, 6, 7, 8, 9, or up to 10 substitutions as recited in claim 37; (7) any kind of recombinant reverse transcriptase protein comprising a polypeptide sequence comprising SEQ ID NO: 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90, 92, 94, 96, 98, 100, 102, 104, 106, 108, 110, 112, 114, 116, 118, 120, 122, 124, 126, 128, 130, 132, 134, 136, 138, 140, 142, 144, 146, 148, 150, 152, 154, 156, 158, 160, 162, 164, 166, 168, 170, 172, 174, 176, 178, 180, 182, 184, 186, 188, 190, 192, 194, 196, 198, 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 288, 290, 292, 294, 296, 298, 300, 302, 304, 306, 308, 310, 312, 314, 316, 318, 320, 322, 324, 326, 328, 330, 332, 334, 336, 338, 340, 342, 344, 346, 348, 350, 352, 354, 356, 358, 360, 362, 364, 366, 368, 370, 372, 374, 376, 378, 380, 382, 384, 386, 388, 390, 392, 394, 396, 398, 400, 402, 404, 406, 408, 410, 412, 414, 416, 418, 420, 422, 424, 426, 428, 430, 432, 434, 436, 438, 440, 442, 444, 446, 448, 450, 452, 454, 456. 458, 460. 462, 464, 466, 468, 470, 472, 474, 476, 478, 480, 482, 484, 486, 488, 490, 492, 494, 496, 498, 500, 502, 504, 506, 508, 510, 512, 514, 516, 518, 520, 522, 524, 526, 528, 530, 532, 534, 536, 538, 540, 542, 544, 546, 548, 550, 552, 554, 556, 558, 560, 562, 564, or 566, wherein the polypeptide sequence optionally has 1, 2, 3, 4, 5, 6, 7, 8, 9, or up to 10 substitutions as recited in claim 38; (8) a composition comprising at least the recombinant reverse transcriptase of claim 1; and (9) a kit comprising at least the recombinant reverse transcriptase of claim 1. The claimed inventions as a whole are not adequately described if the claims require essential or critical elements which are not adequately described in the specification and which are not conventional in the art as of Applicants effective filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics (as it relates to the claimed inventions as a whole) such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641, 1646 (1998).
In this instant case, since, according to the specification, SEQ ID NOs: 1 and 2 are wild type of a reverse transcriptase cDNA and its protein sequence and SEQ ID NOs: 3-566 are mutants of SEQ ID NOs:1 and 2 wherein the mutants of SEQ ID NO. 2 have 687 amino acids and 1 to 15 point mutations (see Tables 4,1, 5,1, 6. 1 and 7.1 of US 2023/183790 A1, which is US publication of this instant case), the recombinant reverse transcriptase recited in claims 1-3, 19, and 20 is read as any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, 24, 94, or 352, or to a reference sequence comprising SEQ ID NO: 2, 24, 94, or 352, wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, 24, 94, or 352, or to the reference sequence comprising SEQ ID NO: 2, 24, 94, or 352,
the recombinant reverse transcriptase recited in claims 4 and 6 is read as any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, or to a reference sequence comprising SEQ ID NO: 2 wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, or to the reference sequence comprising SEQ ID NO: 2, the polypeptide sequence comprises at least a substitution at amino acid position 18, 25, 49, 63, 68, 69, 72, 74, 78, 81, 83, 84, 85, 89, 90, 92, 94, 98, 102, 113, 114, 118, 119, 129, 130, 132, 134, 163, 167, 171, 173, 178, 196, 199, 205, 209, 210, 212, 216, 242, 258, 260, 261, 266, 294, 297,298, 300, 303, 305, 307, 308, 309, 310, 311, 314, 317, 319, 321, 329, 331, 333, 338, 342, 343,349, 356, 370, 403, 444, 447, 454, 464, 465, 466, 474, 479, 508, 509, 519, 536, 537, 554, 574, 576, 583, 595, 598, 606, 638, 639, or 662, or combinations thereof, wherein the amino acid positions are relative to the reference sequence of SEQ ID NO: 2, the recombinant reverse transcriptase recited in claims 5 and 7 is read as any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, or to a reference sequence comprising SEQ ID NO: 2 wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, or to the reference sequence comprising SEQ ID NO: 2, the polypeptide sequence comprises at least a substitution 18E, 25E, 49G, 63L/P, 68S, 69R, 72M,74K/M/P, 78V, 81K, 83E/A/C/R/W, 84N, 85R, 89A/M, 901, 92T, 94L, 98S, 102C, 113G/T, 114G/K, 118R, 119Y, 129L, 130R/S, 132F, 134F/P, 163P, 167Y, 171L, 173A, 178L, 196C/H, 199L, 205M, 209A, 210L, 212K/N/V, 216R, 242A, 258T, 260G, 261N, 266V, 294Q, 297W, 298E/R, 3001, 303G/Q, 305P/S, 307K/N, 308G, 309E/P/T, 310R, 311A/I/P, 314A/K/M, 317C, 319C/G/S, 321A, 329S, 331E, 333V, 338V, 342W, 343A/V, 349G, 356P, 370G, 403H, 444L, 447G/L/R, 454A, 464L, 465S, 466K, 474A, 479D, 508L, 509E, 519P, 536E/A/N, 537W, 554T, 574D/Q, 576I, 583K, 595N, 598S, 606K/Q, 638H, 639H, or 662R, or combinations thereof, wherein the amino acid positions are relative to the reference sequence of SEQ ID NO: 2, the recombinant reverse transcriptase recited in claims 21 and 23 is read as any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to a reference sequence comprising SEQ ID NO: 2 wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to the reference sequence comprising SEQ ID NO: 24, 94, or 352, the polypeptide sequence comprises at least a substitution at amino acid position 18, 25, 49, 63, 68, 69, 72, 74, 78, 81, 83, 84, 85, 89, 90, 92, 94, 98, 102, 113, 114, 118, 119, 129, 130, 132, 134, 163, 167, 171, 173, 178, 196, 199, 205, 209, 210, 212, 216, 242, 258, 260, 261, 266, 294, 297, 298, 300, 303, 305, 307, 308, 309, 310, 311, 314, 317, 319, 321, 329, 331, 333, 338, 342, 343,349, 356, 370, 403, 444, 447, 454, 464, 465, 466, 474, 479, 508, 509, 519, 536, 537, 554, 574, 576, 583, 595, 598, 606, 638, 639, or 662, or combinations thereof, wherein the amino acid positions are relative to the reference sequence of SEQ ID NO: 24, 94, or 352, the recombinant reverse transcriptase recited in claims 22 and 24 is read as any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to a reference sequence comprising SEQ ID NO: 24, 94, or 352 wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to the reference sequence comprising SEQ ID NO: 24, 94, or 352, the polypeptide sequence comprises at least a substitution 18E, 25E, 49G, 63L/P, 68S, 69R, 72M,74K/M/P, 78V, 81K, 83E/A/C/R/W, 84N, 85R, 89A/M, 901, 92T, 94L, 98S, 102C, 113G/T, 114G/K, 118R, 119Y, 129L, 130R/S, 132F, 134F/P, 163P, 167Y, 171L, 173A, 178L, 196C/H, 199L, 205M, 209A, 210L, 212K/N/V, 216R, 242A, 258T, 260G, 261N, 266V, 294Q, 297W, 298E/R, 3001, 303G/Q, 305P/S, 307K/N, 308G, 309E/P/T, 310R, 311A/I/P, 314A/K/M, 317C, 319C/G/S, 321A, 329S, 331E, 333V, 338V, 342W, 343A/V, 349G, 356P, 370G, 403H, 444L, 447G/L/R, 454A, 464L, 465S, 466K, 474A, 479D, 508L, 509E, 519P, 536E/A/N, 537W, 554T, 574D/Q, 576I, 583K, 595N, 598S, 606K/Q, 638H, 639H, or 662R, or combinations thereof, wherein the amino acid positions are relative to the reference sequence of SEQ ID NO: 24, 94, or 352, the recombinant reverse transcriptase recited in claim 37 is read as any kind of recombinant reverse transcriptase protein comprising a polypeptide sequence comprising residues 12 to 687 of SEQ ID NO: 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90, 92, 94, 96, 98, 100, 102, 104, 106, 108, 110, 112, 114, 116, 118, 120, 122, 124, 126, 128, 130, 132, 134, 136, 138, 140, 142, 144, 146, 148, 150, 152, 154, 156, 158, 160, 162, 164, 166, 168, 170, 172, 174, 176, 178, 180, 182, 184, 186, 188, 190, 192, 194, 196, 198, 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 288, 290, 292, 294, 296, 298, 300, 302, 304, 306, 308, 310, 312, 314, 316, 318, 320, 322, 324, 326, 328, 330, 332, 334, 336, 338, 340, 342, 344, 346, 348, 350, 352, 354, 356, 358, 360, 362, 364, 366, 368, 370, 372, 374, 376, 378, 380, 382, 384, 386, 388, 390, 392, 394, 396, 398, 400, 402, 404, 406, 408, 410, 412, 414, 416, 418, 420, 422, 424, 426, 428, 430, 432, 434, 436, 438, 440, 442, 444, 446, 448, 450, 452, 454, 456. 458, 460. 462, 464, 466, 468, 470, 472, 474, 476, 478, 480, 482, 484, 486, 488, 490, 492, 494, 496, 498, 500, 502, 504, 506, 508, 510, 512, 514, 516, 518, 520, 522, 524, 526, 528, 530, 532, 534, 536, 538, 540, 542, 544, 546, 548, 550, 552, 554, 556, 558, 560, 562, 564, or 566, wherein the polypeptide sequence has 10 substitutions, the recombinant reverse transcriptase recited in claim 38 is read as any kind of recombinant reverse transcriptase protein comprising a polypeptide sequence comprising SEQ ID NO: 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90, 92, 94, 96, 98, 100, 102, 104, 106, 108, 110, 112, 114, 116, 118, 120, 122, 124, 126, 128, 130, 132, 134, 136, 138, 140, 142, 144, 146, 148, 150, 152, 154, 156, 158, 160, 162, 164, 166, 168, 170, 172, 174, 176, 178, 180, 182, 184, 186, 188, 190, 192, 194, 196, 198, 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 288, 290, 292, 294, 296, 298, 300, 302, 304, 306, 308, 310, 312, 314, 316, 318, 320, 322, 324, 326, 328, 330, 332, 334, 336, 338, 340, 342, 344, 346, 348, 350, 352, 354, 356, 358, 360, 362, 364, 366, 368, 370, 372, 374, 376, 378, 380, 382, 384, 386, 388, 390, 392, 394, 396, 398, 400, 402, 404, 406, 408, 410, 412, 414, 416, 418, 420, 422, 424, 426, 428, 430, 432, 434, 436, 438, 440, 442, 444, 446, 448, 450, 452, 454, 456. 458, 460. 462, 464, 466, 468, 470, 472, 474, 476, 478, 480, 482, 484, 486, 488, 490, 492, 494, 496, 498, 500, 502, 504, 506, 508, 510, 512, 514, 516, 518, 520, 522, 524, 526, 528, 530, 532, 534, 536, 538, 540, 542, 544, 546, 548, 550, 552, 554, 556, 558, 560, 562, 564, or 566, wherein the polypeptide sequence has 10 substitutions, the composition recited in claim 59 is read as a composition comprising at least the recombinant reverse transcriptase of claim 1, and the kit recited in claim 69 is read as a kit comprising at least the recombinant reverse transcriptase of claim 1. Therefore, claims 1-7, 19-24, 37, 38, 59, and 69 encompass numerous unknown and unidentified recombinant reverse transcriptase proteins that miss from the disclosure and it is unclear whether these numerous unknown and unidentified recombinant reverse transcriptase proteins still have reverse transcriptase activities. For example, since SEQ ID NO:2, which is wild type of a recombinant reverse transcriptase protein sequence, contains 687 amino acids, 75% identity to resides 12 to 687 of SEQ ID NO:2, 24, 94, or 352 or 75% identity to SEQ ID NO:2, 24, 94, or 352 means that the differences between the amino acids of the recombinant reverse transcriptase protein recited in claims 1-7, 19-24, 59, and 69 and the amino acids of resides 12 to 687 of SEQ ID NO:2, 24, 94, or 352 or SEQ ID NO:2, 24, 94, or 352 are 160 or 172 amino acids respectively. Since the recombinant reverse transcriptase recited in claim 37 can be read as any kind of recombinant reverse transcriptase protein comprising a polypeptide sequence comprising residues 12 to 687 of SEQ ID NO:422 and having 10 amino acid substitutions and the recombinant reverse transcriptase recited in claim 38 can be read as any kind of recombinant reverse transcriptase protein comprising a polypeptide sequence comprising SEQ ID NO:422 and having 10 substitutions, and the differences between the amino acids of SEQ ID NO:2 and SEQ ID NO:422 are 15 amino acids, the differences between the amino acids of SEQ ID NO:2 and the recombinant reverse transcriptase proteins recited in claims 37 and 38 are 25 amino acids wherein 10 amino acid substitutions can be in any location between the N-terminus and C-terminus of SEQ ID No:422. Furthermore, although molecular sequence of swine retrovirus which contains 1145 amino acids and comprise a polypeptide sequence (ie., residues 69 to 744) having at least 75% identity to SEQ ID NO: 2 or 24 (see Sequence alignment between residues 12-687 of SEQ ID NO:2 and SEQ ID No:81 of US Patent No.7,465,573, Published on December 16, 2008) can be read as a recombinant reverse transcriptase protein recited in claims 1-3, 19, and 20, the specification does not describe the molecular sequence of swine retrovirus. Thus, these unknown and unidentified recombinant reverse transcriptase proteins recited in claims 1-7, 19-24, 37, 38, 59, and 69 have not been described in the specification. In addition, since the specification and available arts do not show that these unknown and unidentified recombinant reverse transcriptase proteins recited in claims 1-7, 19-24, 37, 38, 59, and 69 have reverse transcriptase activities, the reverse transcriptase activities of these numerous unknown and unidentified recombinant reverse transcriptase proteins recited in claims 1-7, 19-24, 37, 38, 59, and 69 are unpredictable. Therefore, the general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed.
With limited disclosure provided by the specification, the skilled artisan cannot envision all unknown and unidentified recombinant reverse transcriptase proteins recited in claims 1-7, 19-24, 37, 38, 59, and 69 and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method used. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of identifying it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991).
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Scope of Enablement
Claims 1-7, 19-24, 37, 38, 59, and 69 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 using a polypeptide sequence consisting of SEQ ID NO:2 as a reverse transcriptase, does not reasonably provide enablement for using a protein comprising a polypeptide having 75% identity to a reference sequence comprising resides 12 to 687 of SEQ ID NO: 2, 24, 94 or 352 or a reference sequence comprising SEQ ID NO: 2, 24, 94 or 352 recited in claims 1-7, 19-24, 37, 38, 59, and 69 as a reverse transcriptase. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) the court considered the issue of enablement in molecular biology. The Court summarized eight factors to
be considered in a determination of “undue experimentation”. These factors include: (a) the quantity of experimentation necessary; (b) the amount of direction or guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the relative skill of those in the art; (g) the predictability of the art; and (h) the breadth of the claims. The Court also stated that although the level of skill in molecular biology is high, results of experiments in molecular biology are unpredictable.
To begin, there is no direction or guidance to show that a protein comprising a polypeptide having 75% identity to a reference sequence comprising resides 12 to 687 of SEQ ID NO: 2, 24, 94 or 352 or a reference sequence comprising SEQ ID NO: 2, 24, 94 or 352 recited in claims 1-7, 19-24, 37, 38, 59, and 69 can be used as a reverse transcriptase. While the relative skill in the art is very high (the Ph.D. degree with laboratory experience), there is no predictability whether a protein comprising a polypeptide having 75% identity to a reference sequence comprising resides 12 to 687 of SEQ ID NO: 2, 24, 94 or 352 or a reference sequence comprising SEQ ID NO: 2, 24, 94 or 352 recited in claims 1-7, 19-24, 37, 38, 59, and 69 can be used as a reverse transcriptase.
Although the specification teaches SEQ ID NOs: 1 and 2 which are wild type of a reverse transcriptase cDNA and its protein sequence and SEQ ID NOs: 3-566 which are mutants of SEQ ID NOs:1 and 2 wherein the mutants of SEQ ID NO. 2 have 687 amino acids and 1 to 15 point mutations (see Tables 4,1, 5,1, 6. 1 and 7.1 of US 2023/183790 A1, which is US publication of this instant case), the scopes of claims 1-7, 19-24, 37, 38, 59, and 69 are much broader than the teachings of the specification because, as mentioned in above written description rejection, the recombinant reverse transcriptase recited in claims 1-3, 19, and 20 is read as any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, 24, 94, or 352, or to a reference sequence comprising SEQ ID NO: 2, 24, 94, or 352, wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, 24, 94, or 352, or to the reference sequence comprising SEQ ID NO: 2, 24, 94, or 352, the recombinant reverse transcriptase recited in claims 4 and 6 is read as any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, or to a reference sequence comprising SEQ ID NO: 2 wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, or to the reference sequence comprising SEQ ID NO: 2, the polypeptide sequence comprises at least a substitution at amino acid position 18, 25, 49, 63, 68, 69, 72, 74, 78, 81, 83, 84, 85, 89, 90, 92, 94, 98, 102, 113, 114, 118, 119, 129, 130, 132, 134, 163, 167, 171, 173, 178, 196, 199, 205, 209, 210, 212, 216, 242, 258, 260, 261, 266, 294, 297,298, 300, 303, 305, 307, 308, 309, 310, 311, 314, 317, 319, 321, 329, 331, 333, 338, 342, 343,349, 356, 370, 403, 444, 447, 454, 464, 465, 466, 474, 479, 508, 509, 519, 536, 537, 554, 574, 576, 583, 595, 598, 606, 638, 639, or 662, or combinations thereof, wherein the amino acid positions are relative to the reference sequence of SEQ ID NO: 2, the recombinant reverse transcriptase recited in claims 5 and 7 is read as any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, or to a reference sequence comprising SEQ ID NO: 2 wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, or to the reference sequence comprising SEQ ID NO: 2, the polypeptide sequence comprises at least a substitution 18E, 25E, 49G, 63L/P, 68S, 69R, 72M,74K/M/P, 78V, 81K, 83E/A/C/R/W, 84N, 85R, 89A/M, 901, 92T, 94L, 98S, 102C, 113G/T, 114G/K, 118R, 119Y, 129L, 130R/S, 132F, 134F/P, 163P, 167Y, 171L, 173A, 178L, 196C/H, 199L, 205M, 209A, 210L, 212K/N/V, 216R, 242A, 258T, 260G, 261N, 266V, 294Q, 297W, 298E/R, 3001, 303G/Q, 305P/S, 307K/N, 308G, 309E/P/T, 310R, 311A/I/P, 314A/K/M, 317C, 319C/G/S, 321A, 329S, 331E, 333V, 338V, 342W, 343A/V, 349G, 356P, 370G, 403H, 444L, 447G/L/R, 454A, 464L, 465S, 466K, 474A, 479D, 508L, 509E, 519P, 536E/A/N, 537W, 554T, 574D/Q, 576I, 583K, 595N, 598S, 606K/Q, 638H, 639H, or 662R, or combinations thereof, wherein the amino acid positions are relative to the reference sequence of SEQ ID NO: 2, the recombinant reverse transcriptase recited in claims 21 and 23 is read as any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to a reference sequence comprising SEQ ID NO: 2 wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to the reference sequence comprising SEQ ID NO: 24, 94, or 352, the polypeptide sequence comprises at least a substitution at amino acid position 18, 25, 49, 63, 68, 69, 72, 74, 78, 81, 83, 84, 85, 89, 90, 92, 94, 98, 102, 113, 114, 118, 119, 129, 130, 132, 134, 163, 167, 171, 173, 178, 196, 199, 205, 209, 210, 212, 216, 242, 258, 260, 261, 266, 294, 297, 298, 300, 303, 305, 307, 308, 309, 310, 311, 314, 317, 319, 321, 329, 331, 333, 338, 342, 343,349, 356, 370, 403, 444, 447, 454, 464, 465, 466, 474, 479, 508, 509, 519, 536, 537, 554, 574, 576, 583, 595, 598, 606, 638, 639, or 662, or combinations thereof, wherein the amino acid positions are relative to the reference sequence of SEQ ID NO: 24, 94, or 352, the recombinant reverse transcriptase recited in claims 22 and 24 is read as any kind of recombinant reverse transcriptase protein or a functional thereof comprising an polypeptide sequence having 75% sequence identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to a reference sequence comprising SEQ ID NO: 24, 94, or 352 wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to the reference sequence comprising SEQ ID NO: 24, 94, or 352, the polypeptide sequence comprises at least a substitution 18E, 25E, 49G, 63L/P, 68S, 69R, 72M,74K/M/P, 78V, 81K, 83E/A/C/R/W, 84N, 85R, 89A/M, 901, 92T, 94L, 98S, 102C, 113G/T, 114G/K, 118R, 119Y, 129L, 130R/S, 132F, 134F/P, 163P, 167Y, 171L, 173A, 178L, 196C/H, 199L, 205M, 209A, 210L, 212K/N/V, 216R, 242A, 258T, 260G, 261N, 266V, 294Q, 297W, 298E/R, 3001, 303G/Q, 305P/S, 307K/N, 308G, 309E/P/T, 310R, 311A/I/P, 314A/K/M, 317C, 319C/G/S, 321A, 329S, 331E, 333V, 338V, 342W, 343A/V, 349G, 356P, 370G, 403H, 444L, 447G/L/R, 454A, 464L, 465S, 466K, 474A, 479D, 508L, 509E, 519P, 536E/A/N, 537W, 554T, 574D/Q, 576I, 583K, 595N, 598S, 606K/Q, 638H, 639H, or 662R, or combinations thereof, wherein the amino acid positions are relative to the reference sequence of SEQ ID NO: 24, 94, or 352, the recombinant reverse transcriptase recited in claim 37 is read as any kind of recombinant reverse transcriptase protein comprising a polypeptide sequence comprising residues 12 to 687 of SEQ ID NO: 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90, 92, 94, 96, 98, 100, 102, 104, 106, 108, 110, 112, 114, 116, 118, 120, 122, 124, 126, 128, 130, 132, 134, 136, 138, 140, 142, 144, 146, 148, 150, 152, 154, 156, 158, 160, 162, 164, 166, 168, 170, 172, 174, 176, 178, 180, 182, 184, 186, 188, 190, 192, 194, 196, 198, 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 288, 290, 292, 294, 296, 298, 300, 302, 304, 306, 308, 310, 312, 314, 316, 318, 320, 322, 324, 326, 328, 330, 332, 334, 336, 338, 340, 342, 344, 346, 348, 350, 352, 354, 356, 358, 360, 362, 364, 366, 368, 370, 372, 374, 376, 378, 380, 382, 384, 386, 388, 390, 392, 394, 396, 398, 400, 402, 404, 406, 408, 410, 412, 414, 416, 418, 420, 422, 424, 426, 428, 430, 432, 434, 436, 438, 440, 442, 444, 446, 448, 450, 452, 454, 456. 458, 460. 462, 464, 466, 468, 470, 472, 474, 476, 478, 480, 482, 484, 486, 488, 490, 492, 494, 496, 498, 500, 502, 504, 506, 508, 510, 512, 514, 516, 518, 520, 522, 524, 526, 528, 530, 532, 534, 536, 538, 540, 542, 544, 546, 548, 550, 552, 554, 556, 558, 560, 562, 564, or 566, wherein the polypeptide sequence has 10 substitutions, the recombinant reverse transcriptase recited in claim 38 is read as any kind of recombinant reverse transcriptase protein comprising a polypeptide sequence comprising SEQ ID NO: 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90, 92, 94, 96, 98, 100, 102, 104, 106, 108, 110, 112, 114, 116, 118, 120, 122, 124, 126, 128, 130, 132, 134, 136, 138, 140, 142, 144, 146, 148, 150, 152, 154, 156, 158, 160, 162, 164, 166, 168, 170, 172, 174, 176, 178, 180, 182, 184, 186, 188, 190, 192, 194, 196, 198, 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 288, 290, 292, 294, 296, 298, 300, 302, 304, 306, 308, 310, 312, 314, 316, 318, 320, 322, 324, 326, 328, 330, 332, 334, 336, 338, 340, 342, 344, 346, 348, 350, 352, 354, 356, 358, 360, 362, 364, 366, 368, 370, 372, 374, 376, 378, 380, 382, 384, 386, 388, 390, 392, 394, 396, 398, 400, 402, 404, 406, 408, 410, 412, 414, 416, 418, 420, 422, 424, 426, 428, 430, 432, 434, 436, 438, 440, 442, 444, 446, 448, 450, 452, 454, 456. 458, 460. 462, 464, 466, 468, 470, 472, 474, 476, 478, 480, 482, 484, 486, 488, 490, 492, 494, 496, 498, 500, 502, 504, 506, 508, 510, 512, 514, 516, 518, 520, 522, 524, 526, 528, 530, 532, 534, 536, 538, 540, 542, 544, 546, 548, 550, 552, 554, 556, 558, 560, 562, 564, or 566, wherein the polypeptide sequence has 10 substitutions, the composition recited in claim 59 is read as a composition comprising at least the recombinant reverse transcriptase of claim 1, and the kit recited in claim 69 is read as a kit comprising at least the recombinant reverse transcriptase of claim 1. Therefore, claims 1-7, 19-24, 37, 38, 59, and 69 encompass numerous unknown and unidentified recombinant reverse transcriptase proteins that miss from the disclosure and it is unclear whether these numerous unknown and unidentified recombinant reverse transcriptase proteins still have reverse transcriptase activities. For example, since SEQ ID NO:2, which is wild type of a recombinant reverse transcriptase protein sequence, contains 687 amino acids, 75% identity to resides 12 to 687 of SEQ ID NO:2, 24, 94, or 352 or 75% identity to SEQ ID NO:2, 24, 94, or 352 means that the differences between the amino acids of the recombinant reverse transcriptase protein recited in claims 1-7, 19-24, 59, and 69 and the amino acids of resides 12 to 687 of SEQ ID NO:2, 24, 94, or 352 or SEQ ID NO:2, 24, 94, or 352 are 160 or 172 amino acids respectively. Since the recombinant reverse transcriptase recited in claim 37 can be read as any kind of recombinant reverse transcriptase protein comprising a polypeptide sequence comprising residues 12 to 687 of SEQ ID NO:422 and having 10 amino acid substitutions and the recombinant reverse transcriptase recited in claim 38 can be read as any kind of recombinant reverse transcriptase protein comprising a polypeptide sequence comprising SEQ ID NO:422 and having 10 substitutions, and the differences between the amino acids of SEQ ID NO:2 and SEQ ID NO:422 are 15 amino acids, the differences between the amino acids of SEQ ID NO:2 and the recombinant reverse transcriptase proteins recited in claims 37 and 38 are 25 amino acids wherein 10 amino acid substitutions can be in any location between the N-terminus and C-terminus of SEQ ID No:422. Furthermore, although molecular sequence of swine retrovirus which contains 1145 amino acids and comprise a polypeptide sequence (ie., residues 69 to 744) having at least 75% identity to SEQ ID NO: 2 or 24 (see Sequence alignment between residues 12-687 of SEQ ID NO:2 and SEQ ID No:81 of US Patent No.7,465,573, Published on December 16, 2008) can be read as a recombinant reverse transcriptase protein recited in claims 1-3, 19, and 20, the specification does not describe the molecular sequence of swine retrovirus. Thus, these unknown and unidentified recombinant reverse transcriptase proteins recited in claims 1-7, 19-24, 37, 38, 59, and 69 have not been described in the specification. In addition, since the specification and available arts do not show that these unknown and unidentified recombinant reverse transcriptase proteins recited in claims 1-7, 19-24, 37, 38, 59, and 69 have reverse transcriptase activities, the reverse transcriptase activities of these numerous unknown and unidentified recombinant reverse transcriptase proteins recited in claims 1-7, 19-24, 37, 38, 59, and 69 are unpredictable. Without knowing these numerous unknown and unidentified recombinant reverse transcriptase proteins, the skilled artisan does not know whether a protein comprising a polypeptide having 75% identity to a reference sequence comprising resides 12 to 687 of SEQ ID NO: 2, 24, 94 or 352 or a reference sequence comprising SEQ ID NO: 2, 24, 94 or 352 recited in claims 1-7, 19-24, 37, 38, 59, and 69 can work as a reverse transcriptase.
Case law has established that “(t)o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright 990 F.2d 1557, 1561. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) it was determined that “[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art”. The amount of guidance needed to enable the invention is related to the amount of knowledge in the art as well as the predictability in the art. Furthermore, the Court in Genentech Inc. v Novo Nordisk 42 USPQ2d 1001 held that “[I]t is the specification, not the knowledge of one skilled in the art that must supply the novel aspects of the invention in order to constitute adequate enablement”.
In view of above discussion, the skilled artisan will have no way to predict the experimental results. Accordingly, it is concluded that undue experimentation is required to make the invention as it is claimed. These undue experimentation at least includes to test whether a protein comprising a polypeptide having 75% identity to a reference sequence comprising resides 12 to 687 of SEQ ID NO: 2, 24, 94 or 352 or a reference sequence comprising SEQ ID NO: 2, 24, 94 or 352 recited in claims 1-7, 19-24, 37, 38, 59, and 69 can be used as a reverse transcriptase.
Conclusion
In the instant case, as discussed above, the level of unpredictability in the art is high, the specification provides one with no guidance that leads one to claimed methods. One of skill in the art cannot readily anticipate the effect of a change within the subject matter to which the claimed invention pertains. Thus given the broad claims in an art whose nature is identified as unpredictable, the unpredictability of that art, the large quantity of research required to define these unpredictable variables, the lack of guidance provided in the specification, the absence of any working example related to claimed invention and the no teaching in the prior art balanced only against the high skill level in the art, it is the position of the examiner that it would require undue experimentation for one of skill in the art to perform the method of the claim as broadly written.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 19, 20, and 59 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Rogers et al., (US 2018/0010105 A1, published on January 11, 2018).
Regarding claims 1-3, 19, 20, and 59, since residues 13 to 687 SEQ ID NO:4 is 98.9% identity to SEQ ID NO: 20 of US 2018/0010105 A1 while residues 13 to 687 SEQ ID NO:24 is 98.7% identity to SEQ ID NO: 20 of US 2018/0010105 A1 (see the sequence alignment result between residues 13-687 of SEQ ID NO:2 and SEQ ID NO:20 of US 2018/0010105 A1 and the sequence alignment result between residues 13-687 of SEQ ID NO:24 and SEQ ID NO:20 of
US 2018/0010105 A1), mismatch residues between residues 12 to 687 SEQ ID NO:2 to SEQ ID NO: 20 of Rogers et al., is 9 amino acids and mismatch residues between residues 12 to 687 SEQ ID NO:24 to SEQ ID NO: 20 of US 2018/0010105 A1 is 10 amino acids, residues 12 to 687 SEQ ID NO:4 is identity 98.7% (9/677) to SEQ ID NO: 20 of US 2018/0010105 A1 and residues 12 to 687 SEQ ID NO:24 is 98.5% (10/677) identity to SEQ ID NO: 20 of US 2018/0010105 A1. Thus, Rogers et al., teach a recombinant reverse transcriptase protein (ie., SEQ ID No:2) or a functional thereof comprising an polypeptide sequence (ie., residues 1 to 675) having at least 98% sequence identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, 24, 94, or 352, or to a reference sequence comprising SEQ ID NO: 2, 24, 94, or 352, wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, 24, 94, or 352, or to the reference sequence comprising SEQ ID NO: 2, 24, 94, or 352 as recited in claim 1 wherein the polypeptide sequence having at least 98% identity to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, or to the reference sequence comprising SEQ ID NO: 2, wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, or to the reference sequence comprising SEQ ID NO: 2 as recited in claim 2, the polypeptide sequence having at least 98% identity to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to the reference sequence comprising SEQ ID NO: 24, 94, or 352, wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 2, or to the reference sequence comprising SEQ ID NO: 2 as recited in claim 3, the polypeptide sequence having at least 98% identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to a reference sequence comprising SEQ ID NO: 24, 94, or 352 as recited in claim 19, the polypeptide sequence having at least 98% identity to a reference sequence comprising residues 12 to 687 of SEQ ID NO: 24, 94, or 352, or to a reference sequence comprising SEQ ID NO: SEQ ID NO: 24, 94, or 352, wherein the polypeptide sequence comprises one or more substitutions relative to the reference sequence comprising residues 12 to 687 of SEQ ID NO: 24, 94, or 352 as recited in claim 20, and a composition comprising at least one recombinant reverse transcriptase of claim 1 as recited in claim 59.
Therefore, Rogers et al., teach all limitations recited in claims 1-3, 19, 20, and 59.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al., as applied to claims 1-3, 19, 20, and 59 above, and further in view of 1988 Stratagene catalog (page 39).
The teachings of Rogers et al., have been summarized, supra.
Rogers et al., do not disclose a kit comprising at least the recombinant reverse transcriptase of claim 1 as recited in claim 69. However, Rogers et al., teach a kit comprising a mutant of wild type of recombinant M-MLV reverse transcriptase (SEQ ID NO:2) (see paragraphs [0093], [0094], and [0096], claims 107 and 115).
1988 Stratagene catalog teaches a motivation to combine reagents into kit format (page 39).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have made the kit recited in claim 69 by putting SEQ ID NO: 20 of 2018/0010105 A1 into the kit taught by Rogers et al., in view of the prior arts of Rogers et al., and 1988 Stratagene. One having ordinary skill in the art would have been motivated to do so because Rogers et al., teach a kit comprising a mutant of wild type of recombinant M-MLV reverse transcriptase (SEQ ID NO:2) (see paragraphs [0093], [0094], and [0096], claims 107 and 115) and the Stratagene catalog teaches a motivation for combining reagents of use in an assay into a kit, “[E]ach kit provides two services: 1) a variety of different reagents have been assembled and pre-mixed specifically for a defined set of experiments. 2) The other service provided in a kit is quality control” (page 39, column 1).
Conclusion
No claim is allowed.
Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993)(See 37 CAR § 1.6(d)). The CM Fax Center number is (571)273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph.D., whose telephone number is (571)272-0746. The examiner can normally be reached on Monday-Friday from 9 A.M. to 5 P.M.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Dr. Anne Gussow, Ph.D., can be reached on (571)272-6047.
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/FRANK W LU/Primary Examiner, Art Unit 1683 December 10, 2025