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 .
The TrackOne Request, filed September 29, 2025, was granted October 24, 2025. Therefore, this application is accorded special status.
Applicants’ reply to the March 9, 2026 Office Action, filed June 8, 2026, is acknowledged. Applicants cancel claims 16 and 20, and amend claims 1, 7, 10, and 17. Claims 1-15 and 17-19 are pending in this application and are under examination.
Any objection or rejection of record in the previous Office Action, mailed March 9, 2026, which is not addressed in this action has been withdrawn in light of Applicants’ amendments and/or arguments. This action is FINAL.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, U.S. Provisional Patent Application No. 63/481,499 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed applications fail to provide support for “wherein upon transformation of the template plasmid into the genetically-modified bacterial cell of the species, the genetically-modified bacterial cell expresses a transgene encoded by the template plasmid at an increased level,” “wherein the template plasmid is replicated in the genetically-modified bacterial cell with reduced levels of plasmid multimers or concatemers,” “wherein the genetically-modified bacterial cell produces at least 70%, 80%, 90% or 99% less multimers or concatemers,” “wherein the genetically-modified bacterial cell produces at least 70%, 80%, 90% or 99% increase in monomeric plasmid species,” ““wherein the genetically-modified bacterial cell produces at least 70%, 80%, 90% or 99% increase in supercoiled plasmid DNA,” and “wherein the genetically-modified bacterial cell exhibit an increased ratio of monomeric and supercoiled plasmid DNA to multimers and concatemers,”
Therefore, claims 10-15 have an effective filing date of December 22, 2023, which is the filing date of U.S. Provisional Patent Application No. 63/613,843, which is the earliest application to disclose the listed plasmid characteristics described above. Claims 1-9 and 16-20 are deemed to have an effective filing date of January 25, 2023, the filing date of U.S. Provisional Patent Application No. 62/481,499.
Claim Objections
Claims 5 and 6 are objected to because of the following informalities:
At claim 5, line 2, “a” should be changed to “the.”
At claim 6, line 2, “a” should be changed to “the.”
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 17 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. This is a new rejection necessitated by Applicants’ amendments.
At claim 17, lines 3-4, it is not clear what is meant by the phrase “in a comparable expression system.” What characteristics must be present in a wild-type E. coli K12 or B cell expression system in order for the system to be comparable to the Vibrio expression system.
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 1-3, 5-13, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,442,006. This rejection is modified as necessitated by Applicants’ amendments.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘006 patent and the instant application claim a modified Vibrio natriegens organism (cell).
Regarding claims 1 and 7, the ‘006 patent claims a genetically modified Vibrio natriegens bacterial cell having genetic modifications with respect to a parent Vibrio natriegens bacterial cell. The ‘006 patent claims that the modification is to a gene selected from a DAM gene, a DNS gene, a KDO gene, a KdsD gene, an lpxL gene, and an lpxM gene.
Regarding claim 2, the ‘006 patents claims that the genetic modification is a deletion of a sequence having SEQ ID NO: 1.
Regarding claim 5, the ‘006 patent claims a genetic modification to the DNS gene having SEQ ID NO: 16.
Regarding claim 6, the ‘006 patent claims a modification to the DAM gene having a sequence of SEQ ID NO: 12.
Regarding claims 8-9, the ‘006 patent claims that the Vibrio is Vibrio natriegens.
Regarding claim 10, the ‘006 patent claims that transformation of the plasmid into the modified Vibrio natriegens provides for expressing a transgene at an increased level compared to transformation of the plasmid into E. coli K12 or B lacking the genetic modification.
Regarding claim 11, the ‘006 patent claims that the modified Vibrio natriegens has a reduced amount of plasmid multimers or concatemers compared to a non-modified Vibrio natriegens.
Regarding claim 17, the ‘006 patent claims that transformation of the template plasmid into the genetically-modified Vibrio natriegens bacterial cell replicates the template plasmid at a level that is at least 200% greater than the level of template plasmid replication produced in the same amount of time upon transformation of the template plasmid into the E. coli K12 or B strain derivative lacking the genetic modification.
Regarding claim 19, the ‘006 patent claims that culturing the genetically-modified Vibrio natriegens bacterial cell in the growth medium provides for replication with a doubling time of less than 22 minutes, as measured by optical density at 600 nm.
While the ‘006 patent does not specifically claim a percent increase in monomeric plasmids, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that a reduction in the amount of plasmid multimers/concatemers would have a comparable increase in plasmid monomers at the claimed level of at least a 70% reduction in multimers/concatemers relative to at least a 70% increase in monomeric plasmids.
Further, while the ‘006 patent does not specifically claim that the modified Vibrio natriegens has a growth rate at least 40% higher than an unmodified Vibrio natriegens, because the doubling rate is increased compared to the unmodified Vibrio natriegens, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that the growth rate would be comparatively increased as well.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,442,006, as applied to claims 1-3, 5-13, and 16-20 above, and in view of Stroeher et al. (244 Molecular Genetics and Genomics 295-301 (1994). This rejection is modified as necessitated by Applicants’ amendments.
The ‘006 patent claims modified Vibrio natriegens, as discussed above.
The ‘006 patent does not claim a recA mutant of Vibrio natriegens.
Stroeher discloses Vibrio cholerae recA mutants produced by mutating the recA gene (abstract). Stroeher discloses that the Vibrio cholerae strains have an inability to mediate homologous DNA recombination (abstract). Stroeher discloses that the recA mutants to not show altered virulence and are ideal strains for use in complementation studies (abstract).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to provide a recA mutant according to Stroeher to the modified Vibrio bacterial cell claimed by the ‘006 patent because this provides a mutant that can be used in a genetic studies and for plasmid replication, as claimed by the ‘006 patent.
Claims 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,442,006, as applied to claims 1-3, 5-13, and 16-20 above, and in view of Fujita et al. (11 ACS Synthetic Biology 3088-3099 (2022)). This rejection is modified as necessitated by Applicants’ amendments.
The ‘006 patent claims modified Vibrio natriegens, as discussed above.
The ‘006 patent does not claim an increase in supercoiled plasmids.
Regarding claims 14-15, Fujita discloses supercoiling of bacterial chromosomes facilitates genome manipulation because the physical stability of plasmids and chromosomes (abstract and page 2088, paragraph bridging columns 1 and 2). Fujita discloses that supercoiled plasmids can be converted to supercoiled forms using E. coli enzyme mixtures (paragraph bridging pages 3089 and 3090 and Figure 1).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that increasing the supercoiling of the monomeric plasmids claimed by the ‘006 patents because this will provide for increased stability of the plasmids, as disclosed by Fujita. One of ordinary skill in the art would have been motivated to do so because the increased stability will provide for increased ability to manipulate the modified Vibrio bacterial cell to increase expression of transgenes, and increase the growth rate and doubling time of the modified Vibrio bacterial cell.
Response to Amendments and Arguments
Regarding the rejections under 35 U.S.C. § 112(b)/second paragraph, Applicants’ arguments and amendments have been fully considered and are deemed to be persuasive. Therefore, these rejections are withdrawn. However, a new rejection under 35 U.S.C. § 112(b)/second paragraph is set forth above.
Regarding the non-statutory double patenting rejections over U.S. Patent Nos. 10,968,496 and 11,746,321, Applicants’ amendments and arguments have been fully considered, and are deemed to be persuasive. Therefore, these rejections are withdrawn.
Regarding the non-statutory double patenting rejections over U.S. Patent No. 12,442,006, Applicants’ amendments and arguments have been fully considered but are not deemed to be persuasive.
Applicants assert that, in contrast to the instant method claims, the claims in the ‘006 patent are drawn to a genetically-modified Vibrio natriegens bacterial cell having certain modifications.
However, the modifications in the ‘006 Vibrio natriegens are the same as those employed in the instant claims. Here, the instant case is analogous to Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010), where the courts ruled that obviousness-type double patenting exist between previously-disclosed, but newly-claimed utility. Therefore, the claims are not deemed to be patentably distinct.
Applicants state that they are willing to consider filing a Terminal Disclaimer over the ‘006 patent should the claims be otherwise in condition for allowance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636
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