DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 15-19, 24, 25, 30, 31, 33, 35, 37, 38, 40, 41, 43, 44, 46, 47, 49, 50, 52, 53, 55, 56, 58, 59, 61, 62, 65, 70, 73, 76, 82, 85, 87, 96 and 101 are still at issue and are present for examination.
Election/Restrictions
Applicant's election without traverse of Group I, claims 1-7, 13, 15-19, 21, 22, 24, 25, 27, 28, 30, 31, 33, 35, 37, 38, 40, 41, 43, 44, 46, 47, 49, 50, 52, 53, 55, 56, 58, 59, 61, 62, 64, 65, 70, 73 and 101, drawn to a engineered RNA polymerase, in the paper of 6/22/2026, is acknowledged.
Applicant's election without traverse of the following species
Species Group 1: SEQ ID NO: 32,
Species Group 2: SEQ ID NO: 140.
Species Group 3: position 659.
Species Group 4: substitution set 138/311/336/340/388.
.
Species Group 5: substitution set 170.
Species Group 6: substitution set 336.
Species Group 7: substitution set 357/394/664.
Species Group 8: substitution set 720.
Species Group 9: substitution set 38/170/173.
Species Group 10: substitution position 246,
Species Group 11: substitution position 246.
Species Group 12: substitution position 32.
.
Species Group 13: substitution position 150.
Species Group 14: substitution set 56/150/629/660/782.
Species Group 15: substitution position 782
Species Group 16: substitution position 629.
Species Group 17: substitution position 137.
in the paper of 6/22/2026, is acknowledged.
Claims 30, 31, 33, 35, 37, 38, 40, 41, 43, 44, 46, 47, 49, 50, 52, 53, 55, 56, 58, 59, 61, 62, 64, 65, 76, 82, 85, 87 and 96 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
Applicants filing of the information disclosure statement filed on 10/16/2024 and 6/22/2026 are acknowledged. Those references considered have been indicated as such.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms: Triton (paragraph [0386] and 3 additional occurrences), Tween (paragraph [0386] and 6 additional occurrences), Sephadex (paragraph [0392]) which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18 recites “of claim 15” wherein the font of “15” appears larger than the rest of the recitation and other numbers used in the claims. It is suggested that applicants maintain consistency throughout the claims (i.e. same font and size of font).
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 15, 16, 17, 18, 19, 24, 25, 70, 73 and 101, are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claims 1, 15, 16, 17, 18, 19, 24, 25, 70, 73 and 101, are directed to a naturally-occurring functional fragment of an engineered RNA polymerase, or a functional fragment thereof, comprising an amino acid sequence having at least 70% or more sequence identity to a reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, or to a reference sequence corresponding to SEQ ID NO: 32, wherein the amino acid sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, or relative to the reference sequence corresponding to SEQ ID NO: 32, wherein at least one substitution is at position 659, that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 106 USPQ2d 1972 (June 13, 2013). McGraw et al. (Nucleic Acids Research, Vol 13, pp 6753-6766, 1985) evidence that a polypeptide comprising a engineered RNA polymerase, or a functional fragment thereof, comprising an amino acid sequence having at least 70% or more sequence identity to a reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, or to a reference sequence corresponding to SEQ ID NO: 32, wherein the amino acid sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, or relative to the reference sequence corresponding to SEQ ID NO: 32, wherein at least one substitution is at position 659, is a naturally occurring polypeptide and is thus not patent eligible.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 15-19, 24, 25, 70, 73 and 101 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 15-19, 24, 25, 70, 73 and 101 are directed to all possible engineered RNA polymerase, or a functional fragment thereof, comprising an amino acid sequence having at mere 70% sequence identity to a reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or to a reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein the amino acid sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or relative to the reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein at least one substitution is at position 659. There is no disclosure of any particular structure to function/activity relationship in described engineered RNA polymerase, or a functional fragments thereof. The specification fails to describe sufficient representative species of engineered RNA polymerase, or a functional fragment thereof, comprising an amino acid sequence having at mere 70% sequence identity to a reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or to a reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein the amino acid sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or relative to the reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein at least one substitution is at position 659 for which no predictability of structure with correlated functions is apparent.
Regarding the level of skill and knowledge in the art of amino acid mutation, the reference of Singh et al. (Curr. Protein Pept. Sci. 18:1-11, 2017; cited on the attached Form PTO-892) reviews various protein engineering methods and discloses that despite the availability of an ever-growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see p. 7, column 1, top). Also, the unpredictability associated with amino acid mutations is exemplified by the reference of Zhang et al. (Structure 26:1474-1485, 2018; cited on the attached Form PTO-892), which discloses that even a mutation of a surface residue that was predicted to be benign caused significant structural changes and unexpected effects on the function of a polypeptide (p. 1475, column 1).
Given this lack of sufficient representative species of the claimed engineered terminal deoxynucleotidyl transferases, Applicants have failed to sufficiently describe the claimed invention, in such full, clear, concise, and exact terms that a skilled artisan would recognize applicants were in possession of the claimed invention.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Claims 1, 15-19, 24, 25, 70, 73 and 101 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for that engineered RNA polymerase comprising the amino acid sequence of SEQ ID NO: 32, comprising a substitution at position 659, does not reasonably provide enablement for any possible engineered RNA polymerase, or a functional fragment thereof, comprising an amino acid sequence having at mere 70% sequence identity to a reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or to a reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein the amino acid sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or relative to the reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein at least one substitution is at position 659. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required, are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988)) as follows: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claim(s).
Claims 1, 15-19, 24, 25, 70, 73 and 101 are so broad as to encompass any possible engineered RNA polymerase, or a functional fragment thereof, comprising an amino acid sequence having at mere 70% sequence identity to a reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or to a reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein the amino acid sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or relative to the reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein at least one substitution is at position 659. The scope of the claims is not commensurate with the enablement provided by the disclosure with regard to the extremely large number of engineered RNA polymerases, or a functional fragments thereof broadly encompassed by the claims, including any possible engineered RNA polymerase, or a functional fragment thereof, comprising an amino acid sequence having at mere 70% sequence identity to a reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or to a reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein the amino acid sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or relative to the reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein at least one substitution is at position 659. The claims rejected under this section of U.S.C. 112, first paragraph, place minimal if any structural limits on the claimed engineered RNA polymerases, or a functional fragments thereof. Since the amino acid sequence of a protein determines its structural and functional properties, predictability of which changes can be tolerated in a protein's amino acid sequence and obtain the desired activity requires a knowledge of and guidance with regard to which amino acids in the protein's sequence, if any, are tolerant of modification and which are conserved (i.e. expectedly intolerant to modification), and detailed knowledge of the ways in which the proteins' structure relates to its function. However, in this case the disclosure is limited to that RNA polymerases comprising a polypeptide sequence having the amino acid sequence of SEQ ID NO: 32, substitution is at position 659.
While recombinant and mutagenesis techniques are known, it is not routine in the art to screen for multiple substitutions or multiple modifications, as encompassed by the instant claims, and the positions within a protein's sequence where amino acid modifications can be made with a reasonable expectation of success in obtaining the desired activity/utility are limited in any protein and the result of such modifications is unpredictable. In addition, one skilled in the art would expect any tolerance to modification for a given protein to diminish with each further and additional modification, e.g. multiple substitutions.
The specification does not support the broad scope of the claims which encompass any possible engineered RNA polymerase, or a functional fragment thereof, comprising an amino acid sequence having at mere 70% sequence identity to a reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or to a reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein the amino acid sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or relative to the reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein at least one substitution is at position 659, because the specification does not establish: (A) regions of the protein structure which may be modified without effecting RNA polymerase activity; (B) the general tolerance of the RNA polymerase of SEQ ID NO: 32 to modification and extent of such tolerance; (C) a rational and predictable scheme for modifying any amino acid residue of a RNA polymerase of SEQ ID NO: 32 with an expectation of obtaining the desired biological function; and (D) the specification provides insufficient guidance as to which of the essentially infinite possible choices is likely to be successful. Because of this lack of guidance, the extended experimentation that would be required to determine which substitutions would be acceptable to retain the RNA polymerase activities claimed and the fact that the relationship between the sequence of a peptide and its tertiary structure (i.e. its activity) are not well understood and are not predictable (e.g., see Ngo et al. in The Protein Folding Problem and Tertiary Structure Prediction, 1994, Merz et al. (ed.), Birkhauser, Boston, MA, pp. 433 and 492-495, Franceus et al., J. Ind. Microbiol. Biotechnol. Vol 44, pp 687-695, 2017), it would require undue experimentation for one skilled in the art to arrive at the majority of RNA polymerase of the claimed genus having the claimed RNA polymerase activity.
Thus, applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including any possible engineered RNA polymerase, or a functional fragment thereof, comprising an amino acid sequence having at mere 70% sequence identity to a reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or to a reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein the amino acid sequence comprises one or more substitutions relative to the reference sequence corresponding to residues 8 to 890 of SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, or relative to the reference sequence corresponding to SEQ ID NO: 32, 156, 234, 238, 386, 394, 588, 604, 686, 692, 712, or 800, wherein at least one substitution is at position 659. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of those RNA polymerases, or a functional fragments thereof having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
Claim Rejections - 35 USC § 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, 15-19, 24, 25, 70 and 73 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGraw et al. (Nucleic Acids Research, Vol 13, No 18, pp 6753-6766, 1985).
McGraw et al. (Nucleic Acids Research, Vol 13, No 18, pp 6753-6766) disclose the sequence and analysis of the gene for bacteriophage T3 RNA polymerase. McGraw et al. disclose the amino acid sequence of the bacteriophage T3 RNA polymerase and compare it to the bacteriophage T7 RNA polymerase. The amino acid sequence of the disclosed bacteriophage T3 RNA polymerase has greater than 80% sequence identity to instant SEQ ID NO:32 and instant SEQ ID NO:140. The bacteriophage T3 RNA polymerase taught by McGraw et al. also has a substitution at position 659 and position 172 relative to instant SEQ ID NO: 32.
Sequence comparison of instant SEQ ID NO:32 and McGraw et al.:
C;Superfamily: phage T7 DNA-directed RNA polymerase
C;Keywords: early protein; nucleotidyltransferase; transcription
Query Match 81.5%; Score 3820.5; Length 884;
Best Local Similarity 81.6%;
Matches 721; Conservative 69; Mismatches 93; Indels 1; Gaps 1;
Qy 8 MNTI-NIAKNDFSDIELAAIPFNTLADHYGERLAREQLALEHESYEMGEARFRKMFERQL 66
|| | || |||||:|||||||||||||||| ||:|||||||||||:|| || || |||
Db 1 MNIIENIEKNDFSEIELAAIPFNTLADHYGSALAKEQLALEHESYELGERRFLKMLERQA 60
Qy 67 KAGEVADNAAAKPLITTLLPKMIARINDWFEEVKAKRGKRPTAFQFLQEIKPEAVAYITI 126
||||:|||||||||: |||||: || :| || :|:|::|:|: || :|||| |:||:
Db 61 KAGEIADNAAAKPLLATLLPKLTTRIVEWLEEYASKKGRKPSAYAPLQLLKPEASAFITL 120
172
Qy 127 KTTLACLTSADRTTVQAVASAIGRAIEDEARFGRIRDLEAKHFKKNVEEQLNKRVGHVYK 186
| || ||| : ||:|| | :|:|||||||||||||||||||||:|||||||| | |||
Db 121 KVILASLTSTNMTTIQAAAGMLGKAIEDEARFGRIRDLEAKHFKKHVEEQLNKRHGQVYK 180
Qy 187 KAFMQVVEADMLSKGLLGGEAWSSWHKEDSIHVGVRCIEMLIESTGMVSLHRQNAGVVGQ 246
|||||||||||: :||||||||||| || ::|||:| |||||||||:| | | ||| |
Db 181 KAFMQVVEADMIGRGLLGGEAWSSWDKETTMHVGIRLIEMLIESTGLVELQRHNAGNAGS 240
Qy 247 DSETIELAPEYAEAIA TRAGALAGISPMFQPCVVPPKPWTGITGGGYWANGRRPLALVRT 306
| | ::|| || : :| |||||||||||||||||||||| |||||||||||||||||||
Db 241 DHEALQLAQEYVDVLAKRAGALAGISPMFQPCVVPPKPWVAITGGGYWANGRRPLALVRT 300
Qy 307 HSKKGLMRYEDVYMPEVYKAINIAQNTAWSINKWVLAVANVITKWKHCPVRDIPAIEREE 366
||||||||||||||||||||:|:|||||| ||| |||| | | ||:||| |||::||:|
Db 301 HSKKGLMRYEDVYMPEVYKAVNLAQNTAWKINKKVLAVVNEIVNWKNCPVADIPSLERQE 360
Qy 367 LPMKPEDIDMNPEALTAWKRAKAAVYRRDKARKSRRILLEFMLEQANKFANHKAIWFPYN 426
|| ||:||| | || ||:| | :|| |||| |||| ||||||||||||: ||||||||
Db 361 LPPKPDDIDTNEAALKEWKKAAAGIYRLDKARVSRRISLEFMLEQANKFASKKAIWFPYN 420
Qy 427 MDWRGRVYAVSMFNPQGNDMTKGLLTLAKGKPIGKEGYYWLKIHGANCAGVDKVPFPERI 486
|||||||||| |||||||||||||||||||||||:||:||||||||||||||||||||||
Db 421 MDWRGRVYAVPMFNPQGNDMTKGLLTLAKGKPIGEEGFYWLKIHGANCAGVDKVPFPERI 480
Qy 487 KFIEENHENIMACAKSPLENTWWAEQDLPFCFLAFCFEYAGVQHHGLSYNCSLPLAFDGS 546
|||:: ::|:|||| |: |||||||| |||||||||||||| |||||||||||||||||
Db 481 AFIEKHVDDILACAKDPINNTWWAEQDSPFCFLAFCFEYAGVTHHGLSYNCSLPLAFDGS 540
Qy 547 CSGIQHFSAMLRDEVGGRAVNLLPSETVQDIYGIVAKKVNEILQADAINGTDNEVVTVTD 606
||||||||||||||||||||||||||||||||||||:||||||: |||||| ||::||||
Db 541 CSGIQHFSAMLRDEVGGRAVNLLPSETVQDIYGIVAQKVNEILKQDAINGTPNEMITVTD 600
Qy 607 ENTGEISEKVKLGTKALAGQWLAYGVTRSVTKRSVMTLAYGSKEFGFRQQVLEDTIQWAI 666
::|||||||:|||| || |||||||||||||||||||||||||||||||||:|||| ||
Db 601 KDTGEISEKLKLGTSTLAQQWLAYGVTRSVTKRSVMTLAYGSKEFGFRQQVLDDTIQPAI 660
Qy 667 DSGKGLMFTQPNQAAGYMAKLIWESVSVTVVAAVEAMNWLKSAAKLLAAEVKDKKTGEIL 726
|||||||||||||||||||||||::||||||||||||||||||||||||||||||| |||
Db 661 DSGKGLMFTQPNQAAGYMAKLIWDAVSVTVVAAVEAMNWLKSAAKLLAAEVKDKKTKEIL 720
Qy 727 RKRCAVHWVTPDGFPVWQEYKKPIQTRLNLMFLGQFRLQPTINTNKDSEIDAHKQESGIA 786
| |||||| |||||||||||:||:| ||:::||||||||||||| ||| |||||||||||
Db 721 RHRCAVHWTTPDGFPVWQEYRKPLQKRLDMIFLGQFRLQPTINTLKDSGIDAHKQESGIA 780
Qy 787 PNFVHSQDGSHLRKTVVWAHEKYGIESFALIHDSFGTIPADAANLFKAVRETMVDTYESC 846
||||||||||||| |||:|||||||||||||||||||||||| |||||||||| |||:
Db 781 PNFVHSQDGSHLRMTVVYAHEKYGIESFALIHDSFGTIPADAGKLFKAVRETMVITYENN 840
Qy 847 DVLADFYDQFADQLHESQLDKMPALPAKGNLNLRDILESDFAFA 890
||||||| ||||||||:|||||| || ||||||:|||:||||||
Db 841 DVLADFYSQFADQLHETQLDKMPPLPKKGNLNLQDILKSDFAFA 884
Thus, claim(s) 1, 15-19, 24, 25, 70 and 73 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGraw et al. (Nucleic Acids Research, Vol 13, No 18, pp 6753-6766, 1985).
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.
Claim(s) 1, 15-19, 24, 25, 70, 73 and 101 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGraw et al. (Nucleic Acids Research, Vol 13, No 18, pp 6753-6766, 1985).
McGraw et al. teach that the bacteriophage T7 is a prototype of a class of morphologically similar bacterial viruses that synthesize a new DNA-dependent RNA polymerase after they affect their host. McGraw et al. teach that because of their structural simplicity and high degree of template specificity the phage enzymes are attractive models for studies of RNA polymerase promoter interactions. The best characterized member of the group, other than T7, is bacteriophage T3.
McGraw et al. (Nucleic Acids Research, Vol 13, No 18, pp 6753-6766) disclose the sequence and analysis of the gene for bacteriophage T3 RNA polymerase. McGraw et al. disclose the amino acid sequence of the bacteriophage T3 RNA polymerase and compare it to the bacteriophage T7 RNA polymerase. The amino acid sequence of the disclosed bacteriophage T3 RNA polymerase has greater than 80% sequence identity to instant SEQ ID NO:32 and instant SEQ ID NO:140. The bacteriophage T3 RNA polymerase taught by McGraw et al. also has a substitution at position 659 and position 172 relative to instant SEQ ID NO: 32.
One of skill in the art before the effective filing date would have been motivated to clone and express the encoded bacteriophage RNA polymerase taught by McGraw et al. for its use in methods of analysis of RNA polymerase promoter interactions because of the structural simplicity and high degree of template specificity the phage enzymes. Such methods of expression of the T3 RNA polymerase and methods of use in the study of RNA polymerase promoter interaction include compositions (kits) including other necessary components necessary for these studies The expectation of success is high based upon the high level of skill in the art of recombinant DNA technology as exemplified by McGraw et al.
Thus claim(s) 1, 15-19, 24, 25, 73 and 101 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGraw et al. (Nucleic Acids Research, Vol 13, No 18, pp 6753-6766, 1985).
Remarks
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached on 6-3 EST Mon-Fri.
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rgh
8/4/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
Prosecution Insights