Prosecution Insights
Last updated: April 19, 2026
Application No. 17/790,187

METHOD FOR DETERMINING 5-METHYLCYTOSINE CONFIGURATIONS IN DNA

Non-Final OA §101§102§103§112
Filed
Jun 30, 2022
Examiner
KONOPELSKI SNAVEL, SARA ELIZABETH
Art Unit
1658
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Technische Universitaet Dortmund
OA Round
2 (Non-Final)
33%
Grant Probability
At Risk
2-3
OA Rounds
3y 3m
To Grant
63%
With Interview

Examiner Intelligence

Grants only 33% of cases
33%
Career Allow Rate
6 granted / 18 resolved
-26.7% vs TC avg
Strong +30% interview lift
Without
With
+30.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
53 currently pending
Career history
71
Total Applications
across all art units

Statute-Specific Performance

§101
7.7%
-32.3% vs TC avg
§103
27.3%
-12.7% vs TC avg
§102
18.3%
-21.7% vs TC avg
§112
25.7%
-14.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 18 resolved cases

Office Action

§101 §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 . Election/Restrictions Applicant’s election of Group I, claims 1-14, as well as the species of SEQ ID NO: 5 with a substitution at position 12, in the reply filed on 7/24/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Upon further search and examination, the elected species was broadened to include SEQ ID NO: 1-4 and 6-28 with mutations at positions 12, 19, 25, 26, 27, 29, 31, 33, 35, 36, 37, and 45, recited in claims 1-5, along with previously elected SEQ ID NO: 5 with a mutation at position 12. Response to Arguments Applicant’s arguments, filed 12/23/2025 with respect to the rejection(s) of claim(s) 1-14 under 35 U.S.C. 112, 101, 102, and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of amendments. Claim Status Claims 1-2, 4-14 and 16-20 are pending. Claims 16-20 were previously withdrawn as non-elected inventions. Claims 3, 15, 21, and 22 are cancelled. Claims 1, 2, 4, and 13 are currently amended. Priority The application is the 371 national stage entry of PCT/EP2020/087979, filed 12/29/2020, which claims priority to EP19220082.2, filed 12/30/2019. The priority date of 12/30/2019 is acknowledged. New - Specification The use of the terms SNAP tag (Pg 32 “moieties” paragraph and Pg 33, second full paragraph) and Mini-PROTEAN (Pg 40, “Electrophoretic Mobility Shift Assays”), which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. New - Claim Objections Claim 14 is objected to because of the following informalities: the claim recites “wherein the conjugate optionally further comprises an enzyme, or a detectable label”. Remove the comma such that the claim reads “wherein the conjugate optionally further comprises an enzyme or a detectable label” for improved clarity. Appropriate correction is required. New and Maintained/Modified - Claim Interpretation The claims indicate that the substitution positions recited are relative to SEQ ID NO: 1 unless otherwise specified. However, with the exception of SEQ ID NO: 28, all of SEQ ID NO: 1-27 are 45 amino acids in length. Therefore, they all have the same positional numbering relative to each other. Claim 2 requires that the MBD variant further comprise at least one additional substitution selected from 29L, 31A or D, 33E, and 45L using the positional numbering of SEQ ID NO: 1. It is noted that the wild-type, unmutated SEQ ID NO: 6 and 11, as listed in the Sequence Listing, include 33E and 45L. Since these are not “substitutions”, claim 2 has not been rejected based on these residues in SEQ ID NO: 6 and 11. Claim 9 recites the isolated MBD variant further comprising one or more additional amino acid sequences N- and/or C-terminal to the MBD core domain, each 1-80 amino acids in length. There are no limits on the number of additional sequences, each 1-80- amino acids in length, that can be added to either the N- or C-termini; therefore, the claim is being interpreted as being open to any number of additional amino acid additions at either termini. Claim 11 recites functional characteristics of the isolated MBD variants, wherein, relative to its corresponding wildtype sequence, the MBD variant has altered affinity for a DNA molecule comprising a CpG dinucleotide of interest and its complement, in which at least one cytosine nucleobase in the CpG dinucleotide of interest is modified with and selected from the group consisting of 5-methylcytosine, 5-hdyroxymethylcytosine, 5-formylcytosine, and 5-carboxylcytosine. Claim 12 further specifies different combinations of modifications. These limitations describe functional rather than structural elements of the instant invention. As such, the claim is being interpreted based upon the structural limitations (an isolated MBD variant of claim 1) where the functional limitations of claims 11 and 12 are properties endowed by the structure. New - 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 7 and 8 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 7 recites that the MBD core domain comprises any one or more of amino acids from options (1), (2), (3) and combinations thereof. Option (3) encompasses all the amino acids from both (1) and (2) as well as other amino acids. The scope of this claim is indefinite as it is unclear whether it is inclusive of all of the amino acids of (3) or only a subset such as those in (1) or (2). For purposes of examination, the claim is being interpreted as any amino acid of option (3) meets the limitation set forth. Claim 8 recites that the at least one amino acid substitution comprises 29L, 31D/A/H and 33E using the positional numbering of SEQ ID NO: 1. In essence, the scope of the claim is indefinite as it is unclear whether the limitation “the at least one amino acid substitution” refers to the substitutions recited in claim 1 (which would be consistent with the at least one amino acid substitution) or those recited in claim 8 (which would result in the claim not reciting all of the elements of parent claim 1). This allows for multiple interpretations of the claim. One is that the MBD variant comprises the amino acid substitutions 29L, 31D/A/H, and 33E in addition to those recited in claim 1 (such as is recited in claim 2). Another is that the MBD variant only comprises the amino acid substitutions 29L, 31D/A/H, and 33E; in this case, claim 8 would also not further limit parent claim 1. For purposes of examination, the claim is being interpreted as an MBD variant wherein the at least one amino acid substitution 29L, 31D/A/H, and 33E The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 7 and 8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 recites that the isolated MBD variant further comprises any one or more of amino acids listed in (1)-(3) and combinations. All of the amino acids listed in (1)-(3) read on either the naturally-occurring amino acid at that given position and/or the mutations at the given position as recited in claim 1. Therefore, it does not further limit parent claim 1. Claim 8 recites the at least one amino acid substitution comprises 29L, 31D/A/H and 33E using the positional numbering of SEQ ID NO: 1. As stated above, this does not include all of the limitations of parent claim 1, and, thus, is rejected here. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Maintained/Modified - Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1, 6-7, 9, and 11-12 are rejected under 35 U.S.C. 101 because they are directed to a judicial exception. The Supreme Court has given a three-part test for patent eligibility (see flowchart of MPEP 2106(III)): Are the claims drawn to a process, machine, manufacture, or composition of matter? 2a) If the claims pass the first test, are the claims drawn to a judicial exception (a law of nature, a natural phenomenon (product of nature), or an abstract idea)? 2b) If a judicial exception applies, do the claims recite additional elements that amount to significantly more than the judicial exception? Applying the three-part test to the instant claims: Regarding 1), the claims are drawn to peptides, which are compositions of matter. Regarding 2a), the peptides claimed are products of nature. Claim 1 recites an isolated MBD variant, wherein the isolated MBD variant comprises a MBD core domain comprising at least 85% sequence identity relative to any one of SEQ ID NO: 1-28 and at least one amino acid substitution relative to the corresponding wildtype MBD as set forth in SEQ ID NO: 1-28 in at least one of the positions corresponding to positions 12, 25, 26, and 37 in SEQ ID NO: 1, wherein said at least one amino acid substitution in at least one of the positions corresponding to positions 12, 25, 26, and 37 is selected from 12V, 12T, 12A, 12R, 12D, 12L, 12P, 25T, 25A, 25C, 25L, 25Y, 25P, 25S, 26T, 26S, 26F, 26L, 26D, 26V, 26Q, 26M, 37N, 37K, 37Q, 37R, 37V, and 37F using the positional number of SEQ ID NO: 1. SEQ ID NO: 1, 2 and 3 are the methyl-binding domains of human MBD 1, MBD2 and MBD3, respectively; SEQ ID NO: 5 is the methyl-binding domain of the human protein MeCP2. The claims read on the following naturally-occurring MBD1, MBD2, MBD3, and MeCP2 variants: SEQ ID NO: 1 - MBD1 (UniProt identifier Q9UIS9) Y26L (corresponding to Y34L in full-length MBD1) SEQ ID NO: 2 - MBD2 (UniProt identifier Q9UBB5) V25A (corresponding to V177A in full-length MBD2) SEQ ID NO: 3 - MBD3 (UniProt identifier O95983) V12L (corresponding to V20L in full-length MBD3) SEQ ID NO: 5 - MeCP2 (UniProt identifier P51608): V25A (corresponding to V122A in full-length MeCP2) R37F (corresponding to R134F in full-length MeCP2; see Table 1 of Bird et al., US 2021/0101938 A1, filed 3/23/2018) The instant SEQ ID NO: 1, 2, 3, and 5 exhibit 100% sequence identity to the additional instantly claimed sequences: SEQ ID NO: 1 is 100% identical to SEQ ID NO: 15 SEQ ID NO: 2 is 100% identical to SEQ ID NO: 7, 12, and 26 SEQ ID NO: 3 is 100% identical to SEQ ID NO: 8 and 13 SEQ ID NO: 5 is 100% identical to SEQ ID NO: 10, 16, and 17 Therefore, the naturally-occurring mutations above also read on the SEQ ID NO: 7, 8, 10, 12, 13, 15, 16, 17, and 26. Regarding 2b), none of the claims listed above integrate SEQ ID NO: 1-3, 5, 7-8, 10-13, 15-17, and 26 into a practical application as they merely recite the variants themselves, or functional attributes endowed by the structure of the variants themselves, without significantly more. As such, they do not contain elements added to the judicial exception sufficient to render the claims significantly more than the exception. Taken together, the claims are drawn to patent ineligible subject matter and are rejected here. New - 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Rejection of SEQ ID NO: 6 Claim(s) 1, 7, 9, 11, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Heimer et al. (US20170030898A1, published 2/2/2107). Heimer teaches SEQ ID NO: 46 (Sequence Listing), which exhibits 88.2% sequence identity to SEQ ID NO: 6 and has a S12V mutation and a I25T mutation: PNG media_image1.png 182 636 media_image1.png Greyscale Thus, claim 1 is anticipated. Claims 11 and 12 are also anticipated as they recite no additional structural features beyond those of claim 1 (see claim interpretation above). Regarding claim 7, as shown in the sequence above, SEQ ID NO: 46 of Heimer also has 1P, 2A, 3L, 4G, 5P, 6G, 7W, 8K, 9R, 10R, 11E, 13F, 14R, 15K, 16S, 17G, 18A, 19T, 20C, 21G, 22R, 23S, 24D, 26Y, 27Y, 28Q, 29S, 30P, 31T, 32G, 33D, 34R, 35I, 36R, 37S, 38K, 39V, 40E, 41L, 42T, 43R, 44Y, and 45L. Regarding claim 9, SEQ ID NO: 46 of Heimer consists of an additional 8 residues at the N-terminus and 17 residues at the C-terminus (Sequence Listing). Regarding claim 14, Heimer teaches generating fusion proteins ([0104-0106]). Rejection of SEQ ID NO: 11 Claim(s) 1, 7, 9, 11, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Heimer et al. (US20170030898A1, published 2/2/2107). Heimer teaches SEQ ID NO: 46, which exhibits 90.4% sequence identity to SEQ ID NO: 11 and has a A12V mutation and a I25T mutation: PNG media_image2.png 194 632 media_image2.png Greyscale Thus, claim 1 is anticipated. Claims 11 and 12 are also anticipated as they recite no additional structural features beyond those of claim 1 (see claim interpretation above). Regarding claim 7, as shown in the sequence above, SEQ ID NO: 46 of Heimer also has 1P, 2A, 3L, 4G, 5P, 6G, 7W, 8K, 9R, 10R, 11E, 13F, 14R, 15K, 16S, 17G, 18A, 19T, 20C, 21G, 22R, 23S, 24D, 26Y, 27Y, 28Q, 29S, 30P, 31T, 32G, 33D, 34R, 35I, 36R, 37S, 38K, 39V, 40E, 41L, 42T, 43R, 44Y, and 45L. Regarding claim 9, SEQ ID NO: 46 of Heimer consists of an additional 8 residues at the N-terminus and 17 residues at the C-terminus (Sequence Listing). Regarding claim 14, Heimer teaches generating fusion proteins ([0104-0106]). Rejection of SEQ ID NO: 22 Claim(s) 1, 7, 9, 11, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Huang et al. (US20070166704A1, published 7/19/2007). Huang teaches SEQ ID NO: 245, which exhibits 86.4% sequence identity to SEQ ID NO: 22 and has a Y26F mutation: PNG media_image3.png 182 646 media_image3.png Greyscale Thus, claim 1 is anticipated. Claims 11 and 12 are also anticipated as they recite no additional structural features beyond those of claim 1 (see claim interpretation above). Regarding claim 7, as shown in the sequence above, SEQ ID NO: 245 of Huang also has 2A, 3L, 4P, 5Q, 6G, 7W, 8E, 9R, 10E, 11E, 12V, 13P, 14R, 15R, 16S, 17G, 18L, 19S, 20A, 21G, 22H, 23R, 24D, 25V, 27Y, 28Y, 29S, 30P, 31S, 32G, 33K, 34K, 35F, 36R, 37S, 38K, 39P, 40Q, 41L, 42A, 43R, 44Y, and 45L. Regarding claim 9, SEQ ID NO: 245 of Huang consists of an additional 8 residues at the N-terminus and >80 residues at the C-terminus (Sequence Listing). Regarding claim 14, Huang teaches generating fusion proteins ([0151]). New - 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. Rejection of SEQ ID NOs: 6 and 11 Claim(s) 1, 7, 9-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Heimer et al. (US20170030898A1, published 2/2/2107) in view of Jørgensen et al. (Jørgensen HF, Adie K, Chaubert P, Bird AP. Engineering a high-affinity methyl-CpG-binding protein. Nucleic Acids Res. 2006 Aug 7;34(13):e96.). The teachings of Heimer have been set forth above. Heimer does not teach an isolated MBD variant wherein the one or more additional amino acid sequences N- and/or C-terminal to the MBD core domain correspond to the corresponding wildtype MBD as set forth in any one of SEQ ID NO: 1-28 and comprise 10 or less substitutions relative to the corresponding wildtype MBD as set forth in any one of SEQ ID NO: 1-28. Jørgensen teaches creation of a poly-MBD protein (Abstract, Figure 1A). The poly-MBD protein displays methyl-CpG-specific binding in vitro and has an improved dissociation constant compared to monomeric MBD. Poly-MBD proteins can localize to methylated foci in cells and are useful for the detection of DNA methylation levels in isolated native DNA and for cytological detection of chromosomal CpG methylation (Abstract). Regarding claim 10, Heimer teaches variants of SEQ ID NO: 6 and 11 with altered affinity for CpG methylated residues. Jørgensen teaches poly-MBD proteins are useful in the detection of DNA methylation levels. Based on these teachings, it would be prima facie obvious to create a poly-MBD protein, comprised of multiple copies of either SEQ ID NO: 6 or SEQ ID NO: 11 taught by Heimer, in order to enhance the ability of the MBD variant to interact with different forms of methylated DNA, particularly in assays used to detect less abundant types of methylation. One skilled in the art would have a reasonable expectation of success as Jørgensen established that the poly-MBD protein using wildtype MBDs substantially improve its ability to detect CpG methylation without loss in sensitivity. Rejection of SEQ ID NO: 22 Claim(s) 1, 7, 9-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et a. (US20070166704A1, published 7/19/2007) in view of Jørgensen et al. (Jørgensen HF, Adie K, Chaubert P, Bird AP. Engineering a high-affinity methyl-CpG-binding protein. Nucleic Acids Res. 2006 Aug 7;34(13):e96.). The teachings of Huang have been set forth above. Huang does not teach an isolated MBD variant wherein the one or more additional amino acid sequences N- and/or C-terminal to the MBD core domain correspond to the corresponding wildtype MBD as set forth in any one of SEQ ID NO: 1-28 and comprise 10 or less substitutions relative to the corresponding wildtype MBD as set forth in any one of SEQ ID NO: 1-28. Jørgensen teaches creation of a poly-MBD protein (Abstract, Figure 1A). The poly-MBD protein displays methyl-CpG-specific binding in vitro and has an improved dissociation constant compared to monomeric MBD. Poly-MBD proteins can localize to methylated foci in cells and are useful for the detection of DNA methylation levels in isolated native DNA and for cytological detection of chromosomal CpG methylation (Abstract). Regarding claim 10, Huang teaches a variant of SEQ ID NO: 22 with altered affinity for CpG methylated residues. Jørgensen teaches poly-MBD proteins are useful in the detection of DNA methylation levels. Based on these teachings, it would be prima facie obvious to create a poly-MBD protein, comprised of multiple copies of SEQ ID NO: 22 taught by Huang, in order to enhance the ability of the MBD variant to interact with different forms of methylated DNA, particularly in assays used to detect less abundant types of methylation. One skilled in the art would have a reasonable expectation of success as Jørgensen established that the poly-MBD protein using wildtype MBDs substantially improve its ability to detect CpG methylation without loss in sensitivity. Prior Art Cited but not Referenced SEQ ID NO: 6 Several additional pieces of art disclose a peptide identical to SEQ ID NO: 46 of Heimer, described above; these peptides also exhibit 88.2% sequence identity to the instant SEQ ID NO: 6 and include mutations S12V and I25T. A subset of this art includes: SEQ ID NO: 6 of US20030082552A1 effectively filed 9/28/2001 SEQ ID NO: 904 of US20220275386A1 effectively filed 5/27/2016 SEQ ID NO: 38 of US20040018550A1 effectively filed 7/28/1997 SEQ ID NO: 2315 of US20040101874A1 effectively filed 4/4/2003 SEQ ID NO: 822213, 822215-822218, 82224-82228, 822232 and 822234-822236 of US20070083334A1 effectively filed 5/31/2006 Plus additional references not listed here SEQ ID NO: 11 Several additional pieces of art disclose a peptide identical to SEQ ID NO: 46 of Heimer, described above; these peptides also exhibit 90.4% sequence identity to the instant SEQ ID NO: 11 and include mutations A12V and I25T. A subset of this art includes: SEQ ID NO: 6 of US20030082552A1 effectively filed 9/28/2001 SEQ ID NO: 904 of US20220275386A1effectively filed 5/27/2016 SEQ ID NO: 38 of US20040018550A1 effectively filed 7/28/1997 SEQ ID NO: 2315 of US20040101874A1 effectively filed 4/4/2003 SEQ ID NO: 822213, 822215-822218, 82224-82228, 822232 and 822234-822236 of US20070083334A1 effectively filed 5/31/2006 Plus additional references not listed here SEQ ID NO: 22 Several additional pieces of art disclose a peptide identical to SEQ ID NO: 245 of Huang, described above; these peptides also exhibit 86.4% sequence identity to the instant SEQ ID NO: 22 and include a Y26F mutation. This art includes: SEQ ID NO: 2567 and 2572 of US20080039413A1 effectively filed 10/21/2003 SEQ ID NO: 1167 of US20050255114A1 effectively filed 4/7/2003 SEQ ID NO: 4 and 8 of US7098012 effectively filed 11/12/1997 SEQ ID NO: 7662 of 6812339 effectively filed 4/14/2000 Summary of Claims and Allowable Subject Matter Claims 1, 6-12, and 14 are rejected. Claims 2, 4, 5, and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara E Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST. 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, Melissa L Fisher can be reached at 571-270-7430. 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. /SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658 /FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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Prosecution Timeline

Jun 30, 2022
Application Filed
Sep 22, 2025
Non-Final Rejection — §101, §102, §103
Dec 23, 2025
Response Filed
Mar 09, 2026
Non-Final Rejection — §101, §102, §103 (current)

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Study what changed to get past this examiner. Based on 3 most recent grants.

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Prosecution Projections

2-3
Expected OA Rounds
33%
Grant Probability
63%
With Interview (+30.0%)
3y 3m
Median Time to Grant
Moderate
PTA Risk
Based on 18 resolved cases by this examiner. Grant probability derived from career allow rate.

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