aNotice 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 Non-Final Office Action is responsive to the communication received 10/30/2025.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 10/30/2025 of Group I, Claim(s) 1-14 is acknowledged.
Applicant has elected without traverse in the Reply filed on 10/30/2025 the following species:
A. the method with the steps using selecting a plurality of types of plasmids comprising the obtained long-chain DNA fragment and reusing the plasmids as the plasmids in step (B) (claim 12)
The Restriction/Election Requirements are deemed proper and are made FINAL.
Claims 1-16 are pending.
Claims 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 10/30/2025.
Claims 1-14 are under examination in this Office Action.
Claim Rejections - 35 USC § 103(a)
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103(a) 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.
5. Secondary considerations (objective evidence of nonobviousness): a) commercial success; b) long felt need; c) evidence of unexpected results; d) skepticism of experts; and e) copying.
Common Ownership of Claimed Invention Presumed
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the Examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the Examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-14 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tsuge et al. (01/12/2017) US Patent Application Publication 2017/0009243 A1 cited in the 3/24/2023 IDS (hereinafter referred to as "Tsuge 2017") in view of Ranganathan (12/21/2000) PCT International Patent Application Publication WO 00/77181 A2 cited in the 3/24/2023 IDS (hereinafter referred to as "Ranganathan") and Tsuge et al. (2015) Scientific Reports volume 5 pages 1 to 11 cited in the 3/24/2023 IDS (hereinafter referred to as "Tsuge 2015").
With regards to claims 1-3 and 10-14, Tsuge 2017 teaches:
a) as in claims 1-3 and 10-14, a preparation method of a DNA fragment, the DNA fragment having at least one insert DNA unit comprising: a DNA comprising a replication origin effective in a host; and an insert DNA in which unit DNAs are linked, characterized in that the method comprises: (A) processing a plurality of types of plasmids comprising an insert DNA unit in which a plurality of types of unit DNAs are linked in a specific linking order with a restriction enzyme, and preparing a plurality of types of unit DNA mixture solutions; and (B) re-assembling the plurality of types of unit DNAs by ordered gene assembly in Bacillus subtilis (OGAB) method using the DNA obtained in step (A) to prepare a long-chain DNA fragment; wherein the DNA fragment is a DNA fragment for cell transformation; wherein the replication origin is effective in a host microorganism, and the DNA fragment for cell transformation is for microbial cell transformation; plasmid comprising a DNA fragment obtained by a preparation method of a DNA fragment, the DNA fragment having at least one insert DNA unit comprising: a DNA comprising a replication origin effective in a host; and an insert DNA in which unit DNAs are linked, characterized in that the method comprises: (A) processing a plurality of types of plasmids comprising an insert DNA unit in which a plurality of types of unit DNAs are linked in a specific linking order with a restriction enzyme, and preparing a plurality of types of unit DNA mixture solutions; and (B) re-assembling the plurality of types of unit DNAs by ordered gene assembly in Bacillus subtilis (OGAB) method using the DNA obtained in step (A) to prepare a long-chain DNA fragment; a preparation method of a DNA fragment, the DNA fragment having at least one insert DNA unit comprising: a DNA comprising a replication origin effective in a host; and an insert DNA in which unit DNAs are linked, characterized in that the method comprises: (A) preparing a plurality of types of plasmids from the long-chain DNA fragment prepared by a preparation method of a DNA fragment, the DNA fragment having at least one insert DNA unit comprising: a DNA comprising a replication origin effective in a host; and an insert DNA in which unit DNAs are linked, characterized in that the method comprises: (A) processing a plurality of types of plasmids comprising an insert DNA unit in which a plurality of types of unit DNAs are linked in a specific linking order with a restriction enzyme, and preparing a plurality of types of unit DNA mixture solutions; and (B) re-assembling the plurality of types of unit DNAs by ordered gene assembly in Bacillus subtilis (OGAB) method using the DNA obtained in step (A) to prepare a long-chain DNA fragment; further comprising selecting a plurality of types of plasmids comprising the obtained long-chain DNA fragment and reusing the plasmids as the plasmids in step (B); a method for constructing a chimeric plasmid library, using a preparation method of a DNA fragment, the DNA fragment having at least one insert DNA unit comprising: a DNA comprising a replication origin effective in a host; and an insert DNA in which unit DNAs are linked, characterized in that the method comprises: (A) processing a plurality of types of plasmids comprising an insert DNA unit in which a plurality of types of unit DNAs are linked in a specific linking order with a restriction enzyme, and preparing a plurality of types of unit DNA mixture solutions; and (B) re-assembling the plurality of types of unit DNAs by ordered gene assembly in Bacillus subtilis (OGAB) method using the DNA obtained in step (A) to prepare a long-chain DNA fragment; a method of cell transformation comprising transforming a cell with a DNA fragment prepared by a preparation method of a DNA fragment, the DNA fragment having at least one insert DNA unit comprising: a DNA comprising a replication origin effective in a host; and an insert DNA in which unit DNAs are linked, characterized in that the method comprises: (A) processing a plurality of types of plasmids comprising an insert DNA unit in which a plurality of types of unit DNAs are linked in a specific linking order with a restriction enzyme, and preparing a plurality of types of unit DNA mixture solutions; and (B) re-assembling the plurality of types of unit DNAs by ordered gene assembly in Bacillus subtilis (OGAB) method using the DNA obtained in step (A) to prepare a long-chain DNA fragment (see Figures 1 to 12 and [0002] to [0032] and [0059] to [0120]).
Tsuge 2017 does not explicitly teach:
a) as in claims 1, 6, 8-9 and 11, (A) processing a plurality of types of plasmids comprising an insert DNA unit in which a plurality of types of unit DNAs are linked in a specific linking order with a restriction enzyme suitable for each plasmid to cleave the plasmids into a plurality of types of unit DNAs, and preparing a plurality of types of unit DNA mixture solutions; characterized in that all the ratios between molar concentrations of DNA fragments in the plurality of types of unit DNA mixture solutions obtained in step (A) are 0.8 to 1.2; wherein the number of types of the restriction enzymes used in step (A) is three or less; wherein the restriction enzyme is a restriction enzyme that produces an overhang end; (B) processing the plurality of types of plasmids with a restriction enzyme suitable for each plasmid to cleave the plasmids into a plurality of types of unit DNAs and preparing a plurality of types of unit DNA mixture solutions.
With regards to claims 1, 6, 8-9 and 11, Ranganathan teaches:
a) as in claims 1, 6, 8-9 and 11, (A) processing a plurality of types of plasmids comprising an insert DNA unit in which a plurality of types of unit DNAs are linked in a specific linking order with a restriction enzyme suitable for each plasmid to cleave the plasmids into a plurality of types of unit DNAs, and preparing a plurality of types of unit DNA mixture solutions; characterized in that all the ratios between molar concentrations of DNA fragments in the plurality of types of unit DNA mixture solutions obtained in step (A) are 0.8 to 1.2; wherein the number of types of the restriction enzymes used in step (A) is three or less; wherein the restriction enzyme is a restriction enzyme that produces an overhang end; (B) processing the plurality of types of plasmids with a restriction enzyme suitable for each plasmid to cleave the plasmids into a plurality of types of unit DNAs and preparing a plurality of types of unit DNA mixture solutions (see pages 7 to 18).
One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have had a reasonable expectation of success in arriving at the Applicant's invention as claimed with the above cited references before them. One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have recognized the advantages of combining Ranganathan specific teachings regarding the restriction enzyme method with Tsuge's 2017 general teachings regarding the restriction enzyme method in order to assembling several DNA units in sequence in a DNA construct using restriction enzymes to insert a desired DNA units into a DNA construct followed by ligation to create a DNA construct with the desired DNA sequences inserted into the DNA construct.
Tsuge 2017 does not explicitly teach:
a) as in claims 1, 4-5, 7 and 11, (B) re-assembling the plurality of types of unit DNAs by ordered gene assembly in Bacillus subtilis (OGAB) method using the plurality of types of unit DNA mixture solutions to prepare a long-chain DNA fragment; further comprising preparing the plurality of types of plasmids prior to step (A); wherein the plurality of types of plasmids is prepared by OGAB method; characterized in that in the plurality of types of plasmids, the number of types of unit DNAs comprised in one type of insert DNA unit is 3 to 60; ; and (C) re-assembling the plurality of types of unit DNAs by OGAB method using the plurality of types of unit DNA mixture solutions to prepare a long-chain DNA fragment.
With regards to claims 1, 4-5, 7 and 11, Tsuge 2015 teaches:
a) as in claims 1, 4-5, 7 and 11, (B) re-assembling the plurality of types of unit DNAs by ordered gene assembly in Bacillus subtilis (OGAB) method using the plurality of types of unit DNA mixture solutions to prepare a long-chain DNA fragment; further comprising preparing the plurality of types of plasmids prior to step (A); wherein the plurality of types of plasmids is prepared by OGAB method; characterized in that in the plurality of types of plasmids, the number of types of unit DNAs comprised in one type of insert DNA unit is 3 to 60; ; and (C) re-assembling the plurality of types of unit DNAs by OGAB method using the plurality of types of unit DNA mixture solutions to prepare a long-chain DNA fragment (see entire document, especially Abstract, Figures 1 and 2, and pages 2 to 6).
One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have had a reasonable expectation of success in arriving at the Applicant's invention as claimed with the above cited references before them. One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have recognized the advantages of combining Tsuge's 2015 specific OGAB method with Tsuge's 2017 and Ranganathan's general OGAB method because the construction of synthetic pathways and genetic circuits requires efficient gene assembly of large numbers of DNA fragments created by rapidly constructing designer long DNA from short DNA fragments and OGAB is a one step method for DNA assembly that can assemble unprecedentedly large numbers of fragments. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the time of the effective filing date of the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice .
/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684