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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in KR on Sept 25, 2020 and Sept 17, 2021. However, applicant has not filed a certified copy of English translation of the 10-2020-0125080 and 10-2021-0124777 application as required by 37 CFR 1.55. Claims 1-8 for domestic priority to PCT/KR2021/013043, filed on Sept 24, 2021, is acknowledged.
Specification
The disclosure is objected to because of the following informalities: In [047], "2nd to 204th amino acids of the wide DmpR" should read wild type.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., law of nature, natural phenomenon, or product of nature) without significantly more. The claims recite naturally-occurring nucleic acid sequences. This judicial exception is not integrated into a practical application and the claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception.
Regarding claims 1-7, see the subject matter eligibility test below:
Step 1:
The claims recite "a vector". The specification teaches the vector is used for gene regulation ([041]), and it may include a ribosomal binding site ([051]), cloning sites ([057]), and components required for a plasmid ([067-070]). Under the broadest reasonable interpretation, “vector” is interpreted as a nucleic acid sequence encoding a promoter and/or a polypeptide. Thus, the claimed invention is directed to a process, machine, manufacture, or composition of matter.
Step 2A, Prong 1:
Regarding claim 1, Pseudomonas strain CF600 naturally carries a conjugative catabolic plasmid, pVI150 (Shingler et al., J. Bacteriol., 1993, 175, 1596-1604). pVI150 carries two expression cassettes: i) comprising DmpR as a transcriptional regulator and a promoter operably linked thereto, and ii) comprising a dmp operon with phenol hydroxylase and meta-pathway enzymes (i.e., a target polypeptide) and a σ 54-dependent promoter (i.e., Po promoter) operably linked thereto (pg. 1596). Thus, claim 1 is a judicial exception because these expression cassettes are products of nature that lack any markedly different structural or functional characteristics as compared to its closest naturally occurring counterpart.
Regarding claim 2, Shingler teaches the naturally occurring target polypeptide in Pseudomonas strain CF600 is a dmp operon with phenol hydroxylase and meta-pathway enzymes (i.e., a polypeptide capable of improving production of desired metabolite, and a polypeptide capable of promoting growth of the methanotroph on phenols) (pg. 1596). Thus, claim 2 is a judicial exception because these expression cassettes are products of nature that lack any markedly different structural or functional characteristics as compared to its closest naturally occurring counterpart.
Regarding claim 3, Shingler teaches the naturally occurring target polypeptide in Pseudomonas strain CF600 is induced by phenol (pg. 1598, Results section). Thus, claim 3 is a judicial exception because these expression cassettes are products of nature that lack any markedly different structural or functional characteristics as compared to its closest naturally occurring counterpart.
Regarding claim 4, the plasmid pVI150 in Pseudomonas strain CF600 naturally comprises two expression cassettes which necessarily possess directionality that is either the same or opposite. This is an inherent property of any vector comprising more than one expression cassette. Thus, claim 4 is a judicial exception because these expression cassettes are products of nature that lack any markedly different structural or functional characteristics as compared to its closest naturally occurring counterpart.
Regarding claim 5, Pseudomonas strain CF600 naturally comprises the vector with two expression cassettes in a conjugative catabolic plasmid. Thus, claim 5 is a judicial exception because these expression cassettes are products of nature that lack any markedly different structural or functional characteristics as compared to its closest naturally occurring counterpart.
Regarding claims 6 and 7, they recite “the vector of claim 1, wherein the methanotroph…”. Under the broadest reasonable interpretation, claims 6 and 7 recite the vector of claim 1 whereas the methanotroph is the intended use of the naturally occurring vector. Thus, claims 6 and 7 are judicial exceptions because the vector is a product of nature that lack any markedly different structural or functional characteristics as compared to its closest naturally occurring counterpart.
Claims 8 pass the subject matter eligibility test because the claim recites a methanotroph in which the vector of claim 1 is introduced into, and methanotrophs containing the vector of claim 1 does not occur naturally. Thus, this is interpreted as imparting markedly different structural or functional characteristics as compared to its closets naturally occurring expression system. Therefore, this claim is NOT directed to a judicial invention.
Step 2A, Prong 2:
Claims 1-7 do NOT recite any additional elements, and therefore, they do not include recite additional elements that integrate the judicial exception into a practical application.
Step 2B:
Claims 1-7 do NOT recite any additional elements, and therefore, they do not include recite additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102
and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory
basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of
rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same
under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Saville (WO 2015/195972 A1; Published Date: Dec 23, 2015; IDS Received Date: Mar 24, 2023, Cited No. 10) in view of Rugbjerg (US 2018/0327790 A1; Published Date: Nov 15, 2018).
Regarding claim 1, Saville teaches a vector for introduction into methanotroph M. trichosporium OB3b, comprising a first expression cassette comprising a transcriptional regulator and a promoter operably linked thereto; and a second expression cassette comprising a sequence encoding a target polypeptide and a second promoter operably linked thereto (pg. 3). Saville teaches it is advantageous to use diverse metabolite inducible expression cassettes for genetic manipulation of methanotrophic bacteria to reduce the release of methane into the atmosphere from high methane-producing environments (pg. 1).
Saville does not explicitly teach wherein the transcriptional regulator is DmpR and a Po promoter.
Rugbjerg teaches implementations of DmpR transcriptional regulator SEQ ID NO: 108 (same as the instant SEQ 1) with cognate Po promoter SEQ ID NO: 107 (same as the instant SEQ IN NO: 3), with phenol effector metabolite as inducer (Table 13). Rugbjerg further teaches that these specific implementations of biosensors for diverse effector metabolites are suitable for engineering bacteria cells, and for regulating the expression of a gene required for cell growth and/or survival (column 31).
It would have been be obvious to one of ordinary skill in the art before the effective filling date of the invention to have modified Saville’s expression cassette vector with Rugbjerg’s transcriptional regulator DmpR – Po promoter pair because it would have merely amounted to a simple substitution of prior art elements according to known methods to yield predictable results. One would have been motivated to have done so for the advantage of genetically-modified methanotrophic bacteria carrying an orthogonal phenol-inducible catabolic pathway that is capable of metabolizing toxic phenolic compounds and producing metabolites. One would have had a reasonable expectation of success in doing so because both Saville and Rugbjerb teach the use of metabolite inducible expression cassettes in bacteria.
Regarding claim 2, Saville teaches wherein the target polypeptide is a marker, a reporter, a polypeptide capable of improving production of a desired metabolite, or a polypeptide capable of promoting growth of the methanotroph (pg. 4, lines 19-22).
Regarding claim 3, Saville does not specifically teach expression of the target polypeptide is induced by a phenolic compound.
However, Rugbjerg teaches wherein the expression of the target polypeptide under control of a Po promoter is induced by a phenolic compound (Table 13).
The obviousness of substituting Saville’s expression vector with the transcriptional regulator DmpR -Po promoter pair is discussed and applied above.
Regarding claim 4, Saville teaches wherein transcription directions of the first expression cassette and the second expression cassette are the same or opposite (Fig 2A and 2B).
Regarding claim 5, Saville teaches wherein the vector is a plasmid (Fig 1A).
Regarding claim 6-8, Saville teaches the host cell for introduction of the vector is a methanotroph, specifically M. trichosporium OB3b.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are rejected under on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 8, 12 and 13 of prior U.S. Patent No. 9783859 B2 (hereinafter as ‘859) in view of Saville (WO 2015/195972 A1; Published Date: Dec 23, 2015; IDS Received Date: Mar 24, 2023, Cited No. 10), as evidenced by Shingler (J. Bacteriol., 1993, 175, 1596-1604). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-8, ‘859 teaches an artificial genetic circuit (i.e., vector) comprising two expression cassettes: i) wherein the DmpR or its variant as transcriptional regulator and a promoter are operably linked to each other (claims 8 and 12), and ii) wherein the reporter gene (i.e., target polypeptide) and a promoter are operably linked to each other (claim 7). ‘859 teaches phenolic compounds induce binding of DmpR to a gene expression regulatory region and activate the promoter of the reporter gene (claim 1), wherein the promoter is Po promoter, as evidenced by Shingler that DmpR and Po promoter naturally occur together as a transcriptional regulatory pair in Pseudomonas strain CF600 (pg. 1596). ‘859 further teaches the reporter gene is a fluorescent protein or antibiotic resistance gene (claims 13 and 14). Since the genetic circuit of ‘859 comprises more than one expression cassette, it contains an inherent property where transcription directions are either the same or opposite. ‘859 also teaches the genetic circuit is contained in host cells’ cytoplasm (claim 1, step (a)) using a plasmid (specification, column 11, lines 62-65).
However, ‘859 does not teach introducing the genetic circuit into a methanotroph.
Saville teaches introducing vectors into methanotrophs, specifically methanotroph M. trichosporium OB3b. Saville further teaches that each vector has two metabolite expression cassettes: i) comprising a transcriptional regulator and a promoter operably linked thereto, and ii) comprising a sequence encoding a target polypeptide and a second promoter operably linked thereto (pg. 3).
It would have been be obvious to one of ordinary skill in the art before the effective filling date of the invention to have modified ‘859 host cell with methanotrophic bacteria because it would have merely amounted to a simple substitution of prior art elements according to known methods to yield predictable results. One would have been motivated to have done so for the advantage of using ‘859 genetic circuit to detect phenolic-enzyme activities in methanotrophs. One would have a reasonable expectation of success in doing so because both ‘859 and Saville teach the use of metabolite inducible expression cassettes in bacteria.
Conclusion
No claims are allowable.
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QIWEN SU-TOBON
Examiner
Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636