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 .
DETAILED ACTION
This application is a 371 of PCT/JP2022/021313.
The response filed on February 3, 2026 has been entered.
Election/Restrictions
Applicant's election with traverse of Group II (claims 3-4 and 12) with an election of species of (1) plasmid having at least 80% sequence identity to the SEQ ID NO:23 and (2) Streptomyces as the actinomycetes in the reply filed on February 3, 2026 is acknowledged. The traversal is on the ground(s) that the claims are sufficiently related such that no undue burden would be required to examine the claims together. This is not found persuasive because MPEP 1893(d) states that “unity of invention analysis (not an independent and distinct analysis) is applicable in national stage applications submitted under 35 U.S.C. 371”. Therefore, section of MPEP 803 does not apply to national stage applications submitted under 35 U.S.C. 371.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-2, 5-9, and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 3, 2026.
Status of Claims
Claims 1-9 and 11-12 are pending.
Claims 1-2, 5-9, and 11 are withdrawn.
Claims 3-4 and 12 are under examination.
Foreign Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 15, 2023, January 18, 2024, and August 19, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, page 23, for example. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. Applicant’s cooperation is requested in reviewing the specification for additional embedded hyperlink and/or other form of browser-executable code that may be present in the specification and making the appropriate correction(s).
Claim Objections
Claims 3-4 are objected to because said claims depend from non-elected claim, claim 1. In order to expedite the prosecution, the subject matter of claim 1 has been incorporated into examine claims 3-4. Appropriate correction, incorporating the limitations of the non-elected claim, into claims 3-4 is requested.
Claim 3-4 (depending from claim 1) are objected to because of the following informalities: The microorganisms Bacillus subtilis and Escherichia coli should be italicized. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “DNA sequence encoding a plasmid” The metes and bounds of the limitation in the context of the above claim are not clear. It is unclear how a DNA sequence encodes another DNA sequence. Clarification is requested.
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 3-4 and 12 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.
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' In this case, claims 3-4 have been broadly interpreted to encompass a plasmid comprising (A) a first gene cluster containing any plurality of genes assembled using B. subtilis linked to (B) a second gene cluster containing a replication origin of B. subtilis, a replication origin of E. coli, and any initiation sequence for conjugation to any actinomycete and an actinomycete comprising said plasmid. Claim 12 has been broadly interpreted to encompass any plasmid having at least 80% sequence identity to the DNA sequence of SEQ ID NO:23, wherein the function of the polynucleotides or encoded polypeptides comprised in the plasmid are unknown. Therefore, the claims are drawn to a genus of plasmids having unknown structure or unknown structure and unknown function.
MPEP 2163 I. states that to “satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
MPEP 2163. II.A.3.(a) sates that “Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
According to MPEP 2163.II.A.3.(a).ii), “Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’"
The recitations of “plasmid” and “gene cluster containing the plurality of genes”, and “initiation sequence for conjugation to an actinomycete” fail to provide a sufficient description of the genus of the plasmids and polynucleotides comprised in the plasmid as it merely describes the functional features of the genus without providing any definition of the structural features of the species within the genus. The specification does not specifically define any of the species that fall within the genus. The specification does not define any structural features commonly possessed by members of the genus that distinguish them from others. One skilled in the art therefore cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus.
Tsuge (One step assembly of multiple DNA fragments with a designed order and orientation in Bacillus subtilis plasmid. Nucleic Acids Res. 2003 Nov 1;31(21):e133 – form PTO-1449) discloses a plasmid obtained by OGAB (Ordered Gene Assembly in B. subtilis), wherein the plasmid comprises a first gene cluster containing plurality of genes (antibiotic resistance genes) by a DNA assembly using B. subtilis linked to a second gene cluster containing a replication of origin of Bacillus subtilis and a replication origin of Escherichia coli (abstract, Figure 1, and pages 2-3 “Material and Methods”). However, the prior art does not disclose assembling any gene clusters into the plasmid nor conjugating the plasmid to any actinomycete or any Streptomyces,
The specification is limited to the description of a plasmid having the nucleic acid sequence of SEQ ID NO:23, encoding the PKS biosynthetic enzymes. While MPEP 2163 acknowledges that in certain situations “one species adequately supports a genus,” it also acknowledges that “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.” In view of the widely variant species encompassed by the genus, the example described above is not enough and does not constitute a representative number of species to describe the whole genus. Therefore, the specification fails to describe a representative species of the claimed genus.
Claim 12 encompasses many functionally unrelated polynucleotides encompassed within the scope of these clams, including partial sequences, resulting in a substantial variation within the genus. The genus of these polynucleotides comprises a large variable genus with the potentiality of having different activity or no activity. The specification is limited to a plasmid having the nucleic acid sequence of SEQ ID NO:23, encoding the PKS biosynthetic enzymes. While MPEP 2163 acknowledges that in certain situations “one species adequately supports a genus,” it also acknowledges that “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.” In view of the widely variant species encompassed by the genus, the example described is not enough and does not constitute a representative number of species to describe the whole genus of polynucleotide or encoded polypeptides having any function or unknown function. Therefore, one skilled in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
Given this lack of description of the representative species encompassed by the genus of the claims, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the inventions of claims 3-4 and 12.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsuge (One step assembly of multiple DNA fragments with a designed order and orientation in Bacillus subtilis plasmid. Nucleic Acids Res. 2003 Nov 1;31(21):e133 – form PTO-1449) and Bierman (Plasmid cloning vectors for the conjugal transfer of DNA from Escherichia coli to Streptomyces spp. Gene. 1992 Jul 1;116(1):43-9. – form PTO-892).
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”. In the instant case, the structure of the claimed plasmid and actinomycete implied is the same whether the claimed plasmid and actinomycete is obtained from the method of claim 1 or is obtained by any recombinant technique, as long as the resulting product has the structural limitations recited in the claims.
Regarding claim 3, Tsuge discloses a plasmid obtained by the OGAB method (Ordered Gene Assembly in B. subtilis), wherein the plasmid comprises a first gene cluster containing plurality of genes (antibiotic biosynthetic gene clusters) by DNA assembly using B. subtilis linked to a second gene cluster containing a replication of origin of Bacillus subtilis and a replication origin of Escherichia coli (abstract, Figure 1, and pages 2-3 “Material and Methods”). Tsuge discloses that the OGAB method allows for the design of multiple fragments with very high efficiency and great fidelity and assembly of a number of genes (abstract and last full paragraph at page 7).
Tsuge does not disclose conjugating the plasmid to a Streptomyces, an actinomycete.
Regarding claims 3-4, Bierman discloses using an oriT (initiation sequence) for conjugal transfer of plasmids to Streptomyces (abstract and page 44, left column). Bierman discloses that Streptomyces are known for their ability to synthesize commercially useful secondary metabolites, such as antibiotics, and discloses antibiotic biosynthetic gene clusters (page 43).
Therefore, in combining the above references, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was effectively filed to apply the OGBA method of Tsuge to arrive at a Streptomyces comprising a plasmid containing antibiotic biosynthetic gene clusters. One having ordinary skill in the art would have been motivated to do so in order to assemble gene clusters in Streptomyces with high fidelity and efficiency. One having ordinary skill in the art would have had a reasonable expectation of success since Tsuge teaches a ORBA method in assembling gene clusters (antibiotic biosynthetic gene clusters) and Bierman teaches oriT for conjugal transfer of plasmids to Streptomyces and that Streptomyces are known for their ability to synthesize commercially useful secondary metabolites, such as antibiotics, and discloses antibiotic biosynthetic gene clusters. The rationale supporting that the claims would have been obvious is that a method of enhancing a particular class of devices (OGBA method of assembling gene clusters) has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. One of ordinary skill in the art would have been capable of applying this known method of enhancement to a “base” device (actinomycete/Streptomyces for producing antibiotic biosynthetic gene cluster) in the prior art and the results would have been predictable to one of ordinary skill in the art.
Therefore, the above references render claims 3-4 prima facie obvious.
Conclusion
Claims 1-9 and 11-12 are pending.
Claims 1-2, 5-9, and 11 are withdrawn.
Claims 3-4 and 12 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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/YONG D PAK/Primary Examiner, Art Unit 1652
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