Prosecution Insights
Last updated: April 19, 2026
Application No. 18/008,139

BACTERIAL STRAINS FOR DNA PRODUCTION

Non-Final OA §102§103§112
Filed
Dec 02, 2022
Examiner
TINSLEY, BRENDAN THOMAS
Art Unit
1634
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Modernatx Inc.
OA Round
1 (Non-Final)
56%
Grant Probability
Moderate
1-2
OA Rounds
3y 9m
To Grant
99%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allow Rate
15 granted / 27 resolved
-4.4% vs TC avg
Strong +65% interview lift
Without
With
+65.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
40 currently pending
Career history
67
Total Applications
across all art units

Statute-Specific Performance

§101
7.9%
-32.1% vs TC avg
§103
29.5%
-10.5% vs TC avg
§102
14.2%
-25.8% vs TC avg
§112
37.0%
-3.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 27 resolved cases

Office Action

§102 §103 §112
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 . Claim Status Claims 1-3, 5-6, 11, 13-14, 18-19, 25, 30-31, 34-36, 39, 44, 48, and 76 are pending. Applicant’s election without traverse of the invention of group I drawn to an engineered nucleic acid vector comprising a stationary-phase-induced promoter and a primosome assembly site (PAS) (claims 1-3, 5-6, 11, 13-14) in the reply filed on 08 December, 2025 is acknowledged. Claims 18-19, 25, 30-31, 34-36, 39, 44, 48, and 76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Therefore, claims 1-3, 5-6, 11, and 13-14 are pending and under examination in the present Official Action. Priority The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2021/035636, filed 03 June, 2021, which claims priority to United States Provisional Application No. 63035630, filed 05 June, 2020. Acknowledgment is made of applicant’s claim for priority. The earliest possible priority for the instant application is 05 June, 2020. Information Disclosure Statement The information disclosure statements (IDS) submitted on 07 September, 2023, and 08 December, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Drawings The drawings submitted on 02 December, 2022 are accepted by the Examiner. Examiner’s Comment It is noted that where reference is made to the instant disclosure in the following Official Action, the Examiner will be referring to the publication of the instant Application (US 2023/0287437). 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. Claims 2 and 6 are 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 2 is unclear as written. First, claim 2 depends from claim 1 which does not set forth any particular sequence for the nucleic acid vector. It is unclear how a person having ordinary skill in the art would determine whether any particular nucleic acid residue within the vector of claim 1 comprises a point-mutation given that no particular sequence is claimed. Second, RNAII is known to a person having ordinary skill in the art to form a stem loop known as SL4 upon interaction with RNAI (See Standley et al., Current genetics 65.1 (2019): 179-192., Fig. 1). It is unclear whether Applicant intends the scope of claim 2 to encompass point mutations that cause the formation of a stem loop on SL4 or whether Applicant instead intends the scope to encompass point mutations that cause the formation of stem loop SL4 on RNAII independent of its normal formation through interaction with RNAI. It is further unclear what is encompassed by the term “critical”. Neither the claim, nor the specification sets forth a definition for the term “critical stem-loop” and it is unclear how one stem-loop would be considered “critical” in relation to any other possible stem-loop. Thus, the claim is unclear and a person having ordinary skill in the art would not be apprised of the scope of patent protection sought. Claim 6 is unclear as written in its recitation of “a sequence of SEQ ID NO: 27”. It is unclear whether Applicant intends the scope of claim 6 to encompass the sequence of SEQ ID NO: 27 or rather to encompass any sequence found within SEQ ID NO: 27. Consequently, a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought. 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 1-3, 5-6, 11, and 13-14 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The instant claims are broadly directed to a genus of engineered nucleic acid vectors defined only in that they comprise a stationary-phase-induced promoter and a primosome assembly site (PAS) with the intended use of enhancing supercooling of a plasmid (para [0103]) . To the extent the instant claims define a sequence for the vector, only claims 6 and 11 require any particular sequence. Claim 6 requires the P(osmY) promoter to have the sequence of SEQ ID NO: 27 and claim 11 requires the nucleic acid vector to have a sequence that is 70% identical to SEQ ID NO: 19, 20, 21, or 22. It is noted that claim 2 recites several sequences but does not require them because they are recited after the recitation of “optionally”. While the sequence-specific claim limitations are narrower than any vector, they still read on a massive genus of nucleic acid vectors (as discussed below). Further, while the claims do not specify any particular function for the nucleic acid vector, the specification teaches that the function of the nucleic acid vectors of the claimed invention is enhanced plasmid DNA production (Specification, [0003]) and supercoiling (para [0103]). The claims do not state with any specificity what structures are required within the engineered nucleic acid vector to impart onto said vector the function of enhanced plasmid DNA production, and even the sequence-specific claim 11 allows the nucleic acid vector to vary by about 1232 of the 4108 nucleotides for SEQ ID NO: 19, about 914 of the 3047 nucleotides for SEQ ID NO: 20, and about 1297 of the 4324 nucleotides for SEQ ID NOs: 21, and 22. Applicants are claiming an undefined number of nucleic acid vectors having a stationary-phase-induced promoter and a PAS and a subgenus of an undefined number of vectors having 70% identity to SEQ ID NO: 19, 20, 21, or 22. The specification teaches that the vectors of the invention function to enhance plasmid DNA production (Specification [0003]). The specification teaches that such a vector can be a recombinant plasmid comprising a nucleic acid sequence with at least 70% identity to SEQ ID NO: 19 or 20 (Specification, [0014]-[0015]) or an engineered nucleic acid vector comprising a nucleic acid having at least 70% identity to SEQ ID NO: 21 or 22 (Specification [0032]-[0037]). The specification goes on to teach that the instant invention combines several modifications to plasmid structure to increase plasmid DNA yield and quality: replacing the native RNAII promoter with a stationary phase induced P(osmY) promoter, introducing point mutations on to RNAII causing the formation of a critical stem loop on RNAII, SL4, that is needed for plasmid DNA replication to begin, and/or incorporating a primosome assembly site on the plasmid backbone (Specification, [0098]). It is noted that these specific features that the specification teaches are connected to the function of enhanced plasmid DNA production and supercoiling are missing from the claims. Specifically, the specification teaches an enhanced plasmid having a PAS of SEQ ID NO:28 inserted on the plasmid backbone and having P(osmY) of SEQ ID NO: 27 in place of the native RNAII promoter (Plasmid 1), and four specific point mutations “encouraging” SL4 formation (Plasmid 2) where the SL4 has a sequence of SEQ ID NO: 29 (para [0006]) and teaches that these plasmids had significantly higher plasmid DNA yields and plasmid supercoiling relative to the control plasmid (Specification, [0098], [0099]). This disclosure is not deemed to be descriptive of the complete structure of a representative number of polypeptide sequences encompassed by the instant claims as one of skill in the art cannot envision all of the variants of Plasmid 1 and Plasmid 2 which would retain the function of enhanced plasmid DNA production. The working examples are specific to SEQ ID NO: 19 (Plasmid 1) and 20 (Plasmid 2) (Specification, TABLE 3), and there is no disclosure of any actual variants of these two humanized polypeptides. Further, where the working examples teach plasmid production and plasmid supercoiling relative to plasmid modifications specifically, they only provide two paragraphs (Specification, [0162]-[0163]). These two paragraphs teach modifications of the pUC origin of replication in a control plasmid (SEQ ID NO: 19). There is no attempt to connect the specific modifications to the particular PAS inserted on the plasmid backbone, P(osmY) in place of the native RNAII promoter, and four specific point mutations “encouraging” SL4 formation modifications taught elsewhere in the specification. Further, reference to SEQ ID NO: 19 as the control plasmid appears to conflict with prior description within the specification which taught SEQ ID NO: 19 as having the PAS inserted on the plasmid backbone, and P(osmY) in place of the native RNAII promoter modifications (see above). Further, while the specification teaches SEQ ID NO: 20 as having four point mutations which “encourage” SL4 formation, the specification stops short of teaching anywhere that said four mutations actually cause such a formation. The skilled artisan understands RNAII SL4 formation to be dependent on RNAI interaction and in the absence of any description of RNAII mutations which cause SL4 formation (for example in the absence of RNAI, or enhanced SL4 formation in the presence of RNAI), Applicant has not described any vector having point mutations causing the formation of a critical stem-loop, SL4 (See Standley, Fig. 1). To the extent that a structure/function relationship can be gleaned from the instant specification, it is with respect to the specific nucleic acid vectors having SEQ ID NO: 19 or 20 having the property of enhancing plasmid DNA production (Specification, TABLE 3, [0162]-[0163]). There is no teaching in the working examples of SEQ ID NO: 21 or 22 having the function of enhancing plasmid DNA production, nor is there a teaching anywhere in the specification of which residues within SEQ ID NO: 19-22 can be changed to retain the functional property, let alone which 1232 of the 4108 nucleotides for SEQ ID NO: 19, 914 of the 3047 nucleotides for SEQ ID NO: 20, or 1297 of the 4324 nucleotides for SEQ ID NOs: 21, and 22 can be changed while retaining the functional property. 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, reduction to drawings, 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 inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021). Further, 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) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). See MPEP 2163(II)(A)(3)(a)(ii). In disclosing only four nucleic acid vectors having the functional property of enhancing plasmid DNA production (SEQ ID NOs: 19-22), applicant has not disclosed a representative number of species for the entire genus claimed because the claimed genus covers species in which the nucleic acid vectors can vary by about 1232 of the 4108 nucleotides for SEQ ID NO: 19, about 914 of the 3047 nucleotides for SEQ ID NO: 20, and about 1297 of the 4324 nucleotides for SEQ ID NOs: 21, and 22, and the replaced nucleotides may be any nucleotides (including a contiguous string of guanosines or cytosines). A skilled artisan would understand that any protein having a substitution of between 914 and 1297 contiguous nucleotides to guanosines or cytosines would cease to have much in common with the unsubstituted variant, and that the same can be said for adenosines or thymidines, and that such nucleic acid vectors would have their plasmid DNA production by bacterial host strains impacted by such substitutions. Hence, the structure/function correlation of a nucleic acid vector is unpredictable, and a skilled artisan would recognize that the vast genus claimed encompasses vectors whose function would be hindered if not abolished by specific nucleotide substitutions. The skilled artisan understands that one nucleotide change in a DNA molecule or one amino acid change in the polypeptide encodes by the DNA molecule could result in loss of it’s biological activity as demonstrated in the generation of sickle-cell anemia wherein one specific amino acid mutation gives rise to the inherited disease (Voet et al., Biochemistry, John Wiley and Sons, 1990, p. 126-129). Further, the skilled artisan also understands that the significance of particular amino acids within a peptide cannot be predicted a priori but must be determined from case to case by painstaking experimental study (Rudinger, J., Peptide Hormones. Palgrave, London, 1976. 1-7. (Page 6, “Conclusions”)) and that it is not known whether there exists an algorithm for predicting the structure of a given protein from its amino acid sequence alone (Ngo et al., The protein folding problem and tertiary structure prediction. Boston, MA: Birkhäuser Boston, 1994. 433-506. (page 492, second full paragraph)). The specification prophetically teaches that an undefined genus of vectors having 70% identity to SEQ ID NO: 19, 20, 21, or 22 will have the function of enhanced plasmid DNA production (Specification, [0014]-[0015], [0032]-[0037]). However, the specification is silent as to what residues within SEQ ID NO: 19-22 are responsible for the functional property aside from those which encode the PAS inserted on the plasmid backbone, and P(osmY) in place of the native RNAII promoter modifications. Thus, a skilled artisan would understand from the teachings of Voet, Rudinger, and Ngo that the results of changing any given nucleotide within SEQ ID NO: 19-22 would be unpredictable and that it would require significant experimentation to determine which variants of SEQ ID NO: 19-22 would still possess the desired function. The claims encompass sequences 70% identical to the full length of SEQ ID NO: 19-22, SEQ ID NO: 19 is 4108 nucleotides long, SEQ ID NO: 20 is 3047 nucleotides long, and SEQ ID NO: 21-22 are 4324 nucleotides long. That 30 percent variance results in a situation in which if a 1232-contiguous nucleotide region within SEQ ID NO: 19 were independently varied among the 4 different naturally occurring nucleotides, there would be 5.469 x 10741 (41232 ) different possible molecules. In fact, since variations could occur anywhere within SEQ ID NO: 19, the actual number of different molecules encompassed by the claims is orders of magnitude higher than 41232. For SEQ ID NO: 20, that 30 percent variance results in a situation in which if a 914-contiguous nucleotide region within SEQ ID NO: 20 were independently varied among the 4 different naturally occurring amino acids, there would be 1.9179 x 10550 (4914 ) different possible molecules. In fact, since variations could occur anywhere within SEQ ID NO: 20, the actual number of different molecules encompassed by the claims is orders of magnitude higher than 2098. Further, the same calculation done for SEQ ID NOs: 21-22 produces 7.44x10780 different molecules. Computer software may provide means for identification of such molecules, but it is not itself an adequate written description of the structure of the claimed invention. Thus, Applicant has not disclosed a representative number of species for the entire genus of sequences claimed. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 1, 5, 6, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jaishankar, et al., Frontiers in microbiology 8 (2017): 2000, hereinafter “Jaishankar”, as evidenced by Standley, et al., Current genetics 65.1 (2019): 179-192, hereinafter “Standley”, Seufert, et al., Cell 48.1 (1987): 73-78, hereinafter “Seufert” and Lange, et al., Journal of bacteriology 175.24 (1993): 7910-7917, hereinafter “Lange”. Regarding claim 1, Jaishankar teaches vectors having stationary phase induced promoters and origins of replication (Jaishankar, Table 4). One such vector has an ori pMB1 origin of replication (Jaishankar, Table 4). The vectors of Jaishankar which comprise an ori pMB1 origin of replication all necessarily comprise a primosome assembly site as evidenced by Standley who teaches that the ori pMB1 origin has a primosome assembly site (Standley, page 3, first partial paragraph). Therefore, the vector of Jaishankar comprises a stationary phase induced promoter and a primosome assembly site as required by instant claim 1. Regarding claim 5, Jaishankar teaches a vector having the pOsmY promoter and pBR322 origin (Jaishankar, Table 4). The vector having the pOsmY promoter of Jaishankar necessarily possesses a primosome assembly site as evidenced by Seufert who teaches that pBR322 has a primosome assembly site (Seufert, “Summary”). Regarding claim 6, the vector of Jaishankar which comprises a pOsmY promoter comprises the sequence of SEQ ID NO: 27 as evidenced by Lange who teaches the vector referenced by Jaishankar and teaches that the vector has a sequence having 100% identity to SEQ ID NO: 27 (Lange, FIG. 7). Regarding claim 14, the vectors of Jaishankar encode reporter genes which themselves encode mRNAs (Jaishankar, Table 4). 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, 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. Claims 1, 2-3, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Jaishankar, et al., Frontiers in microbiology 8 (2017): 2000, hereinafter “Jaishankar”, in view of Standley, et al., Current genetics 65.1 (2019): 179-192, hereinafter “Standley”, and WO 2011/007005 (published: 20 January, 2011) (hereinafter “Grabherr”). Regarding claims 1 and 2, Jaishankar teaches vectors having stationary phase induced promoters and origins of replication (Jaishankar, Table 4). One such vector has an ori pMB1 origin of replication (Jaishankar, Table 4). The vectors of Jaishankar which comprise an ori pMB1 origin of replication all necessarily comprise a primosome assembly site as evidenced by Standley who teaches that the ori pMB1 origin has a primosome assembly site (Standley, page 3, first partial paragraph). Jaishankar teaches that the vast importance of stationary phase promoters had been realized as far back as the 1980s (Jaishankar, page 6, last partial paragraph). Jaishankar further teaches that such promoters should be highly useful for protein production as the growth and production of protein can be uncoupled paving the way for enhanced gene expression (Jaishankar, page 10, last paragraph). Jaishankar does not teach to add point mutations to the vector to cause formation of a critical stem loop on RNAII, SL4. Standley teaches that plasmid copy number is largely regulated at the level of replication initiation via the interaction between RNAI and RNAII (Standley, page 3, first full paragraph). Standley teaches that three stem loops of RNAI interact with three stem loops of RNAII leading to the formation of RNAII SL4 under normal conditions (Standley, page 3, first full paragraph; Fig. 1). Standley teaches a modified pUC19 origin of replication having point mutations which increase the frequency of RNAII SL4 formation (Standley, Fig. 1). Standley teaches that their mutant origin produces a several-fold increase in plasmid copy number relative to the unmodified plasmid (Standley, Fig. 1). Thus, a person having ordinary skill in the art would have been motivated to introduce the mutations taught by Standley to an origin of replication to increase the copy number of a plasmid. Both Jaishankar and Standley teach modifications to plasmids which can enhance gene expression. Jaishankar teaches the use of stationary phase induced promoters while Standley teaches mutations to stabilize RNAII SL4. A person having ordinary skill in the art would reasonably expect the modifications taught by Jaishankar and Standley to function similarly when combined into a single plasmid because both modifications are taught as having similar benefits (enhanced gene expression and increased copy number). Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have mutated the vectors of Jaishankar according to the mutations taught by Standley to stabilize RNAII SL4 and increase the copy number of the plasmids and arrive at the invention claimed in instant claim 2 with a reasonable expectation of success because they would have been motivated to do so to further enhance gene expression from such plasmids and they would have reasonably expected the respective modifications to have similar properties when comined into a single plasmid. Regarding claim 3, neither Jaishankar, nor Standley teach to disrupt or delete the native RNAII promoter. Grabherr teaches systems for plasmid DNA and protein production which allow copy number control (Grabherr, Abstract). Grabherr teaches mutations of the RNAII promoter to adjust the sequence of the promoter to highly active promoters (Grabherr, page 14, lines 6-8). Grabherr teaches that higher levels of RNAII can be achieved by replacing the RNAII promoter with a stronger promoter (Grabherr, page 14, lines 27-30). Therefore, it would have been prima facie obvious to have replaced the RNAII promoter in the vector of Jaishankar with another highly active promoter as taught by Grabherr to increase the copy number of the plasmid and arrive at the invention claimed in instant claim 3 with a reasonable expectation of success because they would have been motivated to do so to achieve higher levels of RNAII than already present in the vectors of Jaishankar and to further enhance gene expression, and they would have reasonably expected the replacement of the RNAII promoter as taught by Grabherr to have similar properties when combined with the vectors having stationary phase induced promoters of Jaishankar. Regarding claim 13, the vectors of Jaishankar have an origin of replication, a stationary phase induced promoter, and an antibiotic resistance gene (Jaishankar, Table 4). With regard to the orientation of those parts in a 5’ to 3’ direction, the mere rearrangement of the parts of the vectors of Jaishankar would have been an obvious matter of design choice. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). Additional Comments None of the prior art of record teach or suggest a sequence having 100% identity to SEQ ID NO: 19-22. Therefore, the nucleotides of SEQ ID NOS: 19-22 are free of the prior art of record. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDAN THOMAS TINSLEY whose telephone number is (703)756-5906. The examiner can normally be reached Mon-Fri 8:00-5:00. 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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARIA G LEAVITT can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BRENDAN THOMAS TINSLEY/Examiner, Art Unit 1634 /MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
Read full office action

Prosecution Timeline

Dec 02, 2022
Application Filed
Feb 25, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
56%
Grant Probability
99%
With Interview (+65.0%)
3y 9m
Median Time to Grant
Low
PTA Risk
Based on 27 resolved cases by this examiner. Grant probability derived from career allow rate.

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