Prosecution Insights
Last updated: May 29, 2026
Application No. 18/467,658

Method for Cell Line Development

Non-Final OA §103§112§DOUBLEPATENT
Filed
Sep 14, 2023
Priority
Mar 03, 2017 — GB 1703418.2 +2 more
Examiner
STEADMAN, DAVID J
Art Unit
1656
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
CYTIVA SWEDEN AB
OA Round
5 (Non-Final)
58%
Grant Probability
Moderate
5-6
OA Rounds
5m
Est. Remaining
87%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
553 granted / 958 resolved
-2.3% vs TC avg
Strong +29% interview lift
Without
With
+29.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
45 currently pending
Career history
1010
Total Applications
across all art units

Statute-Specific Performance

§101
11.7%
-28.3% vs TC avg
§103
48.4%
+8.4% vs TC avg
§102
11.5%
-28.5% vs TC avg
§112
5.6%
-34.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 958 resolved cases

Office Action

§103 §112 §DOUBLEPATENT
DETAILED CORRESPONDENCE Status of the Application A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 6, 2026 has been entered. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 1, 3-8, 10, 12, 13, and 15-17 are pending in the application. Applicant’s amendment to the claims, filed March 6, 2026, is acknowledged. This listing of the claims replaces all prior versions and listings of the claims. Applicant’s remarks filed March 6, 2026 in response to the final rejection mailed January 7, 2026 have been fully considered. Claims 2, 9, and 11 have been canceled by applicant’s amendment filed March 6, 2026 and rejections previously applied to these claims are withdrawn. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Restriction/Election In response to a requirement for restriction/election mailed August 15, 2024, applicant elected species (A2), the first protein of interest is an immunoglobulin or immunoglobulin-like protein (claim 7), and species (B2), the method according to claim 8, wherein selecting the cell with increased capacity to express the first protein of interest comprises performing targeted engineering by applying gene editing methods to introduce, remove or modify genetic material in the genome of said identified cells expressing the first protein of interest (claim 11). Applicant timely traversed the restriction (election) requirement in the reply filed October 9, 2024 and the requirement was deemed proper and made FINAL in the Office action mailed November 29, 2024. Claims 6 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Claims 1, 3-5, 7, 8, 12, 13, and 15-17 are being examined on the merits. Claim Objections Claim 1 is objected to because of the following informalities: Claim 1 is objected to in the recitation of steps “I.”, “II.”, “III.”, “IV.”, and “V.” According to MPEP 608.01(m), “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See MPEP 608.01(m). Applicant may consider replacing “I.”, “II.”, “III.”, “IV.”, and “V.” in claim 1 with “I)”, “II)”, “III)”, “IV)”, and “V)”, respectively. Claim 1 is also objected to in the recitation of “IV. from a final cell or cell population” and in the interest of improving claim form and consistency, it is suggested that the phrase “from a final cell or cell population” be amended to recite “after repeating steps I-II n times.” Claim 1 is also objected to in the recitation of “V. integrating the nucleic acid molecule…in the genome of the resulting cell” and in the interest of improving claim form and consistency, it is suggested that the phrase “the resulting cell” be amended to recite “the cell of step (IV).” Claim Rejections - 35 USC § 112(b) Claims 1, 3-5, 7, 12, 13, and 15-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 1 (claims 3-5, 7, 12, 13, and 15-17 dependent therefrom) is indefinite in the recitation of “the top candidate cell population from step (II)(b) as the recombinant cell in step I” because it is unclear from the claims and the specification as to the defining characteristic(s) of “the top candidate cell population from step (II)(b) as the recombinant cell in step I.” Also, step III of claim 1 is confusing in the recitation of “using the top candidate cell population…as the recombinant cell in step I” because step I of claim 1 recites the alternatives “recombinant cells or cell populations or descendants thereof” and is not limited to isolating clones from a culture of recombinant cells. In the interest of clarifying the phrase “the top candidate cell population from step (II)(b) as the recombinant cell in step I,” applicant may consider amending the noted phrase to recite “cells having the greatest expression of the first protein of interest from step (II)(b) for isolating clones in step I.” Claim Rejections - 35 USC § 112(a) The new matter rejection of claims 1, 3-5, 7, 8, 12, 13, and 15-17 under 35 U.S.C. 112(a) is withdrawn in view of applicant’s amendment to claim 1 to delete the recombinase recognition sequence “roxP.” Claim Rejections - 35 USC § 103 Claims 1, 3-5, 7, 8, 12, 13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (Biotechnol. Prog. September 2015, 11 pages; cited on the IDS filed on September 14, 2024; hereafter “Zhang”) and Bahr et al. (WO 2014/205192 A2; cited on the IDS filed on September 14, 2024; hereafter “Bahr”). The rejection has been modified from its previous version to address applicant’s instant amendment to the claims. As amended, the claims are drawn to a method to obtain a cell suitable for expressing a protein interest comprising the following steps: I. isolating clones from a culture of recombinant cells or cell populations or descendants thereof, II. performing targeted engineering by applying gene editing methods comprising: a) integrating a nucleic acid molecule encoding a single copy of a first protein of interest into a pre-defined site in the genome of a recipient cell; and b) identifying cells expressing the first protein of interest; III. repeating steps I-II n times by using the top candidate cell population from step (II)(b) as the recombinant cell in step I, wherein n is two or more; IV. from a final cell or cell population, creating a cell bank for cell line development by: excising the nucleic acid molecule encoding the first protein of interest from the genome of the identified cells and simultaneously introducing one or several functional sequence elements Q enabling targeted introduction of a nucleic acid molecule encoding a single copy of a second protein of interest into said pre-defined site in the genome, wherein the genome of the recipient cell does not comprise the one or several sequence elements Q prior to excision of the nucleic acid molecule encoding the first protein of interest, V. integrating the nucleic acid molecule encoding the second protein of interest into the pre-defined site in the genome of the resulting cell. Regarding the claim 1 limitation “A method to obtain a cell suitable for expressing a protein of interest,” Zhang relates to recombinase-mediated cassette exchange for monoclonal antibody expression in the commercially relevant CHOK1SV cell line (p. 1, title) and generally discloses a method for constructing a site-specific integration (SSI) system for monoclonal antibody expression in a CHOK1SV cell line (p. 1, Abstract). Regarding steps I, II, and III of claim 1 and claims 8 and 17, Zhang teaches selecting the industrially relevant CHOK1SV cell line for site-specific integration (p. 2, column 2, top) and teaches a vector encoding a single copy of monoclonal antibody cB72.3 flanked by wild-type FRT (F) and mutant FRT (F5) recombination sequences (Figure 1A; p. 4, column 2, middle). Zhang teaches Phase I of the method, which is integrating the vector encoding a single copy of monoclonal antibody cB72.3 into a “hot spot” within the genome of CHOK1SV cells suitable for expression of a gene of interest (p. 4, column 2) and screening cell pools for production of the monoclonal antibody cB72.3 at 3 weeks post-transfection and following evaluation, the top 6 best-performing clones based on productivity and growth characteristics were selected (paragraph bridging pp. 4-5). Zhang does not teach “hot spot” as a pre-defined site in the CHOK1SV genome (as recited in step IIa) of claim 1). However, Bahr teaches a “hot spot” can be a known, chosen genomic locus for recombinant gene expression (paragraph [0064]). Bahr describes a “hot spot” as sites that are recognized as regions in the genome that are known to be transcriptionally active and resistant to gene silencing mechanisms to allow for stable gene expression (paragraph [0064]). Bahr teaches various genomic loci in CHO cells suitable for integrating an exogenous nucleic acid (paragraph [0064] and Table 2) and teaches methods for integrating an exogenous nucleic acid into the genome including the loci of Table 2 (e.g., paragraphs [0079] and [0080]). In view of the combined teachings of Zhang and Bahr, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zhang to integrate the vector encoding a single copy of monoclonal antibody cB72.3 into a known, chosen genomic locus, e.g., a locus taught by Bahr. One would have been motivated to and would have expected success to integrate the vector encoding a single copy of monoclonal antibody cB72.3 into a known, chosen genomic locus because Zhang taught integrating the vector into a “hot spot” of a CHOK1SV cell and Bahr taught a “hot spot” can be a known, chosen genomic locus for recombinant gene expression and teaches various genomic loci in CHO cells for integrating an exogenous nucleic acid. Zhang also does not teach repeating steps I-II n times by using the top candidate cell population from step (II)(b) as the recombinant cell in step I, wherein n is two or more (as recited in step III of claim 1) and wherein n is three or more (as recited in claim 17). However, Bahr teaches an exogenous nucleic acid sequence containing recognition sequences for at least one polynucleotide modification enzyme may be integrated into three, four, five, six, seven, eight, nine, or ten or more genomic locations, noting that multiple copies of the same exogenous nucleic acid sequence may be inserted (paragraph [0065]) and teaches sequentially repeating integration steps with additional exogenous nucleic acid sequences in order to integrate additional exogenous nucleic acid sequences at a different genomic locus (paragraph [0076]). In view of the combined teachings of Zhang and Bahr, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zhang by sequentially repeating integration of a vector encoding a single copy of monoclonal antibody cB72.3 with selected best-performing clones in order to integrate the vector into different genomic loci, e.g., three, four, five, six, seven, eight, nine, or ten or more genomic locations. Regarding step IV of claim 1, Zhang teaches Phase II of the method, which is excision of the nucleic acid encoding the mAb cB72.3 by integrating a the null targeting vector to replace the mAb cB72.3 in the same “hot spot” to create a “landing pad,” thus generating a SSI cell (p. 1, abstract; Figure 1B, step (2); p. 6, column 2, bottom). The null targeting vector comprises at least one sequence element that was not present on the genome prior to integrating the null targeting vector, e.g., TK and PAC selection markers. Regarding step V of claim 1, Zhang teaches Phase III of the method, which is integrating a vector encoding a single copy of Myo mAb, into the F and F5 recombination sites of the landing pad (Figure 1B, step (3); p. 8, columns 1-2). Regarding claims 3-5, Zhang teaches recombinant production of Pfizer’s Myo mAb in Phase III (p. 2, column 2, bottom; p.3, Figure 1; p. 8, columns 1-2). Claim 3 does not structurally and/or functionally limit the recited recombinant protein and given a broadest reasonable interpretation, Myo mAb is considered to be “an active pharmacological ingredient.” Also, Bahr teaches the recombinant protein can be a recombinant protein that is useful in a biotherapeutic application; the recombinant protein can be a recombinant protein that is useful in a diagnostic application; and the recombinant protein can be a recombinant protein that is useful in industrial applications (paragraph [0097]). Regarding claim 7, Zhang teaches the vector of Phase I encodes mAb cB72.3 (Figure 1; p. 4, column 2, middle). Regarding claim 12, Zhang teaches the vector of Phase II comprises positive and negative selection markers TK and PAC (paragraph bridging pp. 5-6). Regarding claim 13, Phase II of Zhang’s method creates a landing pad by recombinase-mediated cassette exchange (p. 1, abstract; Figure 1B, step (2); p. 6, column 2, bottom). Zhang does not teach or suggest creating a landing pad by forming a double strand break with a specific gene editing DNA nuclease at sequence z being unique or rare in the genome. Bahr teaches a targeting endonuclease may be used for targeted integration of the landing pad (paragraph [0072]). More specifically, Bahr teaches introducing into a cell a targeting endonuclease, introducing into the cell at least one donor polynucleotide comprising an exogenous nucleic acid comprising at least one recognition sequence for a polynucleotide modification enzyme (i.e., landing pad), which is flanked by sequences with substantial sequence identity with either side of the genomic locus, and maintaining the cell under conditions that the targeting endonuclease introduces a double-stranded break at the targeted genomic locus and the double-stranded break is repaired by a homology-directed process such that the exogenous nucleic acid is integrated into the targeted site within or proximal to the genomic locus (paragraph [0072]). Bahr teaches the targeting endonuclease may be a “rare-cutter” endonuclease whose recognition sequence occurs rarely or only one in a genome (paragraph [0024]). In view of the combined teachings of Zhang and Bahr, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Phase II of Zhang’s method by creating a landing pad according to the noted teachings of Bahr. One would have been motivated to and would have had a reasonable expectation of success to do this because Zhang teaches creating a landing pad by recombinase-mediated cassette exchange, while Bahr acknowledges the alternative of creating a landing pad by targeting endonuclease cassette exchange. Regarding claim 15, Zhang teaches the vector of Phase I encodes mAb cB72.3 (Figure 1; p. 4, column 2, middle) and teaches the vector of Phase III encodes Myo mAb (p. 2, column 2, bottom; p. 3, Figure 1; p. 8, columns 1-2), i.e., the vectors of Phase I and Phase III each encode monoclonal antibodies. Regarding claim 16, Zhang teaches integrating a single copy of the nucleic acid encoding the Myo mAb in Phase III (p. 8, column 2, bottom to p. 9, columns 1-2). Therefore, claims 1, 3-5, 7, 8, 12, 13, and 15-17 would have been obvious to one of ordinary skill in the art before the effective filing date. RESPONSE TO REMARKS: In summary, applicant argues Zhang teaches a single random integration and Bahr teaches only a single round of clone selection, whereas the claimed method is distinguished over the combination of Zhang and Bahr by iterative integrations into pre-defined sites. Applicant’s arguments are not found persuasive. For reasons stated above, in view of the combined teachings of Zhang and Bahr, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Zhang by sequentially repeating integration multiple times with selected best-performing clones in order to integrate a single copy of monoclonal antibody cB72.3 into different genomic loci, e.g., three, four, five, six, seven, eight, nine, or ten or more genomic locations. Claim Rejections – 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp. U.S. Patent No. 11,136,598 B2 Claims 1, 3-5, 7, 8, 12, 13, and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 9, and 11 of U.S. Patent No. 11,136,598 B2 (cited on the IDS filed on September 14, 2023; hereafter “patent”) in view of Zhang and Bahr. Although the claims at issue are not identical, they are not patentably distinct from each other. The rejection has been modified from its previous version to address applicant’s instant amendment to the claims. Regarding instant claim 1, claim 1 of the patent is drawn to a method for creating a mammalian cell bank for cell line development comprising the following steps: a) providing a recombinant mammalian cell comprising (i) a genomic region that is transcriptionally active during suspension culture of said recombinant cell in a serum free culture medium, and (ii) a recombinant template DNA construct integrated at said genomic region, said recombinant template DNA construct having a region containing elements needed for expression of a template protein of interest and one or several sequence elements enabling the introduction of a donor DNA construct into said template DNA construct; b) generating one or several candidate cells or cell populations descended from the recombinant mammalian cell; c) measuring production traits of said generated candidate cells or cell populations and selecting a top candidate cell or cell population having improved characteristics for production of said template protein of interest when compared with production of the template protein of interest by the recombinant mammalian cell; d) creating a cell bank for cell line development from said top candidate cell or cell population; and e) identifying in the cell bank increases in template protein of interest expression compared to the recombinant mammalian cell following introduction of a modified template DNA construct having been modified to provide increased expression for said template protein of interest by using promoters with increasing strength and/or by using different combinations of translation enhancement elements in the 5'-UTR of genes coding for said template protein of interest; claim 8 of the patent recites the method according to claim 1, further comprising exchanging expression of the template protein of interest for expression of the desired protein of interest by using an expression vector to introduce said donor DNA construct into said genomic region of a cell or cell population obtained from said cell bank; claim 9 of the patent recites the method according to claim 8, wherein the exchange of template DNA construct to said modified template DNA constructs is achieved in the following way: (a) each template DNA construct is designed to have conserved sequence stretches in their 5′- and 3′-ends that are homologous to said genomic region; (b) each template DNA construct is designed to have a gene editing nuclease target sequence where the sequence differs between generation z and z+1; (c) template DNA constructs of generation z and z+1 contain different selection marker(s); (d) a template DNA construct of generation z+1 is introduced together with a gene editing expression vector construct into a cell or cell population containing a DNA construct of generation z and wherein the gene editing expression vector codes for a gene editing nuclease with specificity for said target sequence of the template DNA construct of generation z; (e) cells having undergone the correct exchange via double strand break catalyzed cellular repair mechanisms are enriched by using the difference in selection markers between DNA constructs of generation z and z+1; and (f) DNA analysis methods are applied to ensure the correct exchange for the cells; and claim 11 is drawn to the method of according to claim 1, wherein the donor DNA construct comprises a region encoding a desired protein of interest belonging to the same class as the template protein of interest and the desired protein of interest and template protein of interest are selected from: i) a protein encoded by two or more genes of interest selected from monoclonal antibodies based on naturally occurring scaffolds, bi-specific antibodies based on naturally occurring scaffolds, Fabs, and virus like particles, and ii) a protein encoded by a single gene of interest, selected from growth factors, blood clotting factors, cytokines, hormones, erythropoietins, albumins, virus proteins, virus protein mimics, bacterial proteins, bacterial protein mimics, domain antibodies, ScFvs, Affibodies, DARPINs, multimerization domains, IgG Fc domains, albumin binding domains, and Fc receptor binding domains and fusion proteins based on combinations of the single gene of interest. The claims of the patent do not recite limitations corresponding to a single copy integration (as recited in step (II)(b) of claim 1 and claim 16), repeating steps I-II n times by using the top candidate cell population from step (II)(b) as the recombinant cell in step I, wherein n is two or more (as recited in step III of claim 1), and wherein n is three or more (as recited in claim 17). Zhang teaches integrating a single copy of a construct encoding a monoclonal antibody into a “hot spot” within the genome of CHOK1SV cells (p. 4, column 2). Bahr teaches an exogenous nucleic acid sequence containing recognition sequences for at least one polynucleotide modification enzyme may be integrated into three, four, five, six, seven, eight, nine, or ten or more genomic locations, noting that multiple copies of the same exogenous nucleic acid sequence may be inserted (paragraph [0065]) and teaches sequentially repeating integration steps with additional exogenous nucleic acid sequences in order to integrate additional exogenous nucleic acid sequences at a different genomic locus (paragraph [0076]). In view of the teachings of Zhang and Bahr, it would have been obvious to one of ordinary skill in the art to modify the method of the claims of the patent by sequentially repeating steps a) to c) of claim 1 with the selected top candidate cell population in order to integrate a single copy of the recombinant template DNA construct into different genomic loci, e.g., three, four, five, six, seven, eight, nine, or ten or more genomic locations. Regarding instant claims 3, 7, and 15, claim 11 of the patent recites the method of according to claim 1, wherein the donor DNA construct comprises a region encoding a desired protein of interest belonging to the same class as the template protein of interest and the desired protein of interest and template protein of interest are selected from: i) a protein encoded by two or more genes of interest selected from monoclonal antibodies based on naturally occurring scaffolds, bi-specific antibodies based on naturally occurring scaffolds, Fabs, and virus like particles, and ii) a protein encoded by a single gene of interest, selected from growth factors, blood clotting factors, cytokines, hormones, erythropoietins, albumins, virus proteins, virus protein mimics, bacterial proteins, bacterial protein mimics, domain antibodies, ScFvs, Affibodies, DARPINs, multimerization domains, IgG Fc domains, albumin binding domains, and Fc receptor binding domains and fusion proteins based on combinations of the single gene of interest. Regarding claims 4 and 5, Bahr teaches the recombinant protein can be a recombinant protein that is useful in a biotherapeutic application; the recombinant protein can be a recombinant protein that is useful in a diagnostic application; and the recombinant protein can be a recombinant protein that is useful in industrial applications (paragraph [0097]). Regarding instant claims 8 and 17, claim 7 of the patent recites the method according to claim 1, wherein steps (a) to (e) of claim 1 are iterated in the following way: (i) in a next iteration the top candidate cell population from previous step (e) is used as said recombinant mammalian cell in step (a) after having exchanged said template DNA construct for a modified template DNA construct having been modified to provide increased expression for said template protein of interest compared to template DNA constructs in earlier iterations; and (ii) repeating (a) to (e) until the top candidate cell or cell population has desired properties, based on the accumulation of one or multiple targeted changes. Regarding instant claims 12 and 13, claim 9 of the patent recites the method according to claim 8, wherein the exchange of template DNA construct to said modified template DNA constructs is achieved in the following way: (a) each template DNA construct is designed to have conserved sequence stretches in their 5′- and 3′-ends that are homologous to said genomic region; (b) each template DNA construct is designed to have a gene editing nuclease target sequence where the sequence differs between generation z and z+1; (c) template DNA constructs of generation z and z+1 contain different selection marker(s); (d) a template DNA construct of generation z+1 is introduced together with a gene editing expression vector construct into a cell or cell population containing a DNA construct of generation z and wherein the gene editing expression vector codes for a gene editing nuclease with specificity for said target sequence of the template DNA construct of generation z; (e) cells having undergone the correct exchange via double strand break catalyzed cellular repair mechanisms are enriched by using the difference in selection markers between DNA constructs of generation z and z+1; and (f) DNA analysis methods are applied to ensure the correct exchange for the cells. Regarding instant claim 16, Zhang teaches integrating a single copy of a nucleic acid encoding a monoclonal antibody (p. 8, column 2, bottom to p. 9, columns 1-2). Therefore, claims 1, 3-5, 7, 8, 12, 13, and 15-17 of this application are unpatentable over claims 1, 8, 9, and 11 of the patent in view of Zhang and Bahr. RESPONSE TO REMARKS: Applicant argues the claims of this application are patentably distinct from the claims of the patent. Applicant’s argument is not found persuasive. For reasons stated above, the claims of this application are unpatentable over claims 1, 8, 9, and 11 of the patent. Co-Pending Application No. 17/995,478 The provisional rejection of claims 1, 3-5, 7, 8, 12, 13, 15, and 16 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of co-pending application no. 17/995,478 (reference application) in view of Zhang and Bahr is withdrawn in view of the instant amendment to claim 1. As amended, the claims of this application are patentably distinct from the claims of the reference application. Co-Pending Application No. 17/995,571 The provisional rejection of claims 1, 3-5, 7, 8, 12, 13, 15, and 16 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of co-pending application no. 17/995,571 (reference application) in view of Zhang and Bahr is withdrawn in view of the instant amendment to claim 1. As amended, the claims of this application are patentably distinct from the claims of the reference application. Conclusion Status of the claims: Claims 1, 3-8, 10, 12, 13, and 15-17 are pending. Claims 6 and 10 are withdrawn from further consideration. Claims 1, 3-5, 7, 8, 12, 13, and 15-17 are rejected. No claim is in condition for allowance. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J STEADMAN whose telephone number is (571)272-0942. The examiner can normally be reached on Monday to Friday, 7:30 AM to 4:00 PM. 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, MANJUNATH N. RAO can be reached on 571-272-0939. 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. /David Steadman/Primary Examiner, Art Unit 1656
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Prosecution Timeline

Show 6 earlier events
Jun 11, 2025
Response after Non-Final Action
Aug 13, 2025
Non-Final Rejection mailed — §103, §112, §DOUBLEPATENT
Nov 07, 2025
Response Filed
Jan 07, 2026
Final Rejection mailed — §103, §112, §DOUBLEPATENT
Feb 24, 2026
Examiner Interview Summary
Mar 06, 2026
Request for Continued Examination
Mar 16, 2026
Response after Non-Final Action
Apr 22, 2026
Non-Final Rejection mailed — §103, §112, §DOUBLEPATENT (current)

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Prosecution Projections

5-6
Expected OA Rounds
58%
Grant Probability
87%
With Interview (+29.4%)
3y 1m (~5m remaining)
Median Time to Grant
High
PTA Risk
Based on 958 resolved cases by this examiner. Grant probability derived from career allowance rate.

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