DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election of Group I (Invention I) in the reply filed on 04/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 12, 13, 16-18, 22-29, 32, 33, 35, 39, 40 and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-7, 9 are under consideration in this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-7, 9 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 claim(s) 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a broad and widely varying genus of recombinant polypeptide comprising a T5 DNA polymerase amino acid sequence of any amino acid sequence and structure operably linked to a DNA helicase amino acid sequence of any amino acid sequence and structure. According to MPEP 2163:
“For each claim drawn to a genus: The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)…”
According to MPEP 2163.02:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
The reference of Chica et al. (Curr Opin Biotechnol. 2005 Aug;16(4):378-84; PTO 892) teaches that the complexity of the structure/function relationship in enzymes has proven to be the factor limiting the general application of rational enzyme modification and design, where rational enzyme modification and design requires in-depth understanding of structure/function relationships. The reference of Singh et al. (Curr Protein Pept Sci. 2017, 18, 1-11; PTO 892) reviews protein engineering methods including directed evolution, rational design, semi-rational design, and de-novo design; and states that despite the availability of a 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 entire publication especially Figs.1 and 3, and page 7, left column, lines 8-17). The reference teachings only provide guidance for searching and screening for the claimed recombinant polypeptide.
The specification as originally filed does not disclose a representative number of species encompassed by the claimed genus by actual reduction to practice. The specification as originally filed does not provide a correlation between function and structure to enable one of ordinary skill in the art to predict which amino acid sequences and structures correlate with T5 DNA polymerase activity and DNA helicase activity.
Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants were in possession at the time the application was filed of the claimed genus of recombinant polypeptide comprising a T5 DNA polymerase amino acid sequence of any amino acid sequence and structure operably linked to a DNA helicase amino acid sequence of any amino acid sequence and structure.
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 of this title, 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.
Claims 1-7, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Accession AZY07565 (13-SEP-2012; PTO 892) in view of Accession BDA24837 (30-JUN-2016; ; PTO 892), Bornscheuer et al. (Curr Protoc Protein Sci. 2011 Nov;Chapter 26:Unit26.7; PTO 892),
Andraos et al. (THE JOURNAL OF BIOLOGICAL CHEMISTRY, Volume 279, Issue 48, 26 November 2004, Pages 50609-50618; PTO 892), US20170067037 (2017-03-09; PTO 892), US Patent 5541099 (1996-07-30; PTO 892).
Accession AZY07565 teaches the Enterobacteria phage T5 DNA polymerase having an amino acid sequence that is 100% identical to SEQ ID NO: 1 (see attached record).
The teachings of the reference differ from the claims in that the reference does not teach the claimed recombinant polypeptide comprising a T5 DNA polymerase amino acid sequence operably linked to a DNA helicase amino acid sequence.
Accession BDA24837 teaches the E. coli str. K-12 substr. MG1655 wild-type Rep helicase having an amino acid sequence that is 100% identical to SEQ ID NO: 5 (see attached record).
Bornscheuer et al. teach protein engineering strategies to improve or change the properties of proteins, teach concepts for protein engineering using rational design including substitution and/or deletion of amino acids, directed evolution, and combinations of them where different strategies are presented for identifying the best mutagenesis method, how to identify desired variants by screening or selection, and examples for successful applications are shown which enable researchers to choose the most promising tools to solve their protein engineering challenges (see entire publication especially pages 26.7.1- 26.7.10 and Tables 26.7.1, 26.7.2, and 26.7.3).
Andraos et al. teach a recombinant polypeptide comprising a T5 DNA polymerase amino acid sequence (plasmid expressing a cloned (recombinant) T5 DNA polymerase; page 50610, column 2, paragraph 3). Additionally, Andraos discloses a T5 DNA polymerase amino acid sequence operably linked to a DNA helicase amino acid sequence (the T5 genome encodes both T5 DNA polymerase and NTP-dependent DNA helicase (operably linked); page 50617, column 2, paragraph 4). Andraos et al. teach the replisome requires a DNA helicase in combination with T5 DNA Polymerase (see page 50617, column 1, paragraph 3 and column 2, paragraphs 3-4).
US20170067037 teaches improved DNA polymerases that may be better suited for applications in recombinant DNA technologies, and discloses an error-prone polymerase which is mutated low-fidelity polymerase enzyme may be used in error-prone PCR for mutagenesis (see entire publication and claims especially paragraph [0087]-[0091] and claims 1, 28-32, 45, 46).
US Patent 5541099 teaches cloning and expression of T5 DNA polymerase reduced in 3'-to-5' exonuclease activity, where the polymerase comprises one or more mutations in its amino acid sequence (see entire patent and claims especially claims 1-5)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify and/or combine the reference teachings to make the claimed invention by using the protein engineering teachings of Bornscheuer et al. on the Enterobacteria phage T5 DNA polymerase of Accession AZY07565 to make the claimed error prone DNA polymerase having any of the recited SEQ ID NOs and all of the recited mutations and operably link the modified DNA polymerase to the helicase of Accession BDA24837 using a peptide linker as taught by Andraos et al. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this in order to obtain a recombinant polypeptide that can be used in methods including DNA replication and/or mutagenesis or for further studies on the recombinant polypeptide. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success because modifying DNA polymerases are known in the art as shown by the above reference teachings especially the teachings of US20170067037 and US Patent 5541099. Hence, the claimed invention as a whole is prima facie obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
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