Prosecution Insights
Last updated: August 18, 2026
Application No. 18/423,678

HYBRIDIZATION COMPOSITIONS AND METHODS USING FORMAMIDE

Non-Final OA §103§DP
Filed
Jan 26, 2024
Priority
Sep 30, 2011 — provisional 61/541,355 +3 more
Examiner
CROW, ROBERT THOMAS
Art Unit
1683
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Agilent Technologies Inc.
OA Round
3 (Non-Final)
42%
Grant Probability
Moderate
3-4
OA Rounds
1y 5m
Est. Remaining
74%
With Interview

Examiner Intelligence

Grants 42% of resolved cases
42%
Career Allowance Rate
298 granted / 715 resolved
-18.3% vs TC avg
Strong +32% interview lift
Without
With
+32.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
58 currently pending
Career history
768
Total Applications
across all art units

Statute-Specific Performance

§101
2.3%
-37.7% vs TC avg
§103
39.7%
-0.3% vs TC avg
§102
9.2%
-30.8% vs TC avg
§112
32.7%
-7.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 715 resolved cases

Office Action

§103 §DP
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. The present application is being examined under the pre-AIA first to invent provisions. Continued Examination Under 37 CFR 1.114 2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 23 July 2026 has been entered. Amendments and Status of the Claims 3. This action is in response to papers filed 23 July 2026 in which claim 63 was amended, claim 69 was canceled, and new claims 73-74 were added. All of the amendments have been thoroughly reviewed and entered. All previous rejections not reiterated below are withdrawn in view of the amendments. Applicant’s arguments have been thoroughly reviewed and are addressed following the rejections necessitated by the amendments. 4. Claims 63-68 and 70-74 are under prosecution. 5. This Office Action includes new rejections necessitated by the amendments. Terminal Disclaimer 6. The terminal disclaimer filed on 23 July 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Paten No. 10,662,465 has been reviewed and is accepted. The terminal disclaimer has been recorded. Claim Interpretation 7. The claims are subject to the following interpretation: As noted in the previous Office Action, while affidavits or declarations, such as those submitted under 37 CFR 1.130, 1.131 and 1.132, filed during the prosecution of a prior application do not automatically become a part of this application, it is noted that paragraphs 8-11 of the Declaration filed 8 June 2017 in parent Application No. 14,348,134 (now U.S. Patent No. 10,662,465 B2, issued 26 May 2020; hereafter “the ‘465 Patent”) state that the compositions and methods of “the ‘656 PCT” (i.e., Matthiesen, PCT International Publication No. WO 2010/097656 A1, published 2 September 2010; cited below as prior art) were not meant to be used in a hybridization composition or method. Claim Rejections - 35 USC § 103 8. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made. 9. Claims 63-68 and 73 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stender et al. ((U.S. Patent Application Publication No. US 2002/0137035 A1, published 26 September 2002) in combination with Kato et al. (U.S. Patent Application Publication No. US 2005/0044582 A1, published 24 February 2005) and/or Vogelstein et al. (U.S. Patent No. 5,910,407, issued 8 June 1999). Regarding claim 63-64 and 73, Stender et al. teach methods of hybridizing probes to a target (e.g., blotted RNA), using solutions comprising 10% w/v dextran sulfate and hybridizing for 1.5 hours (i.e., claims 63 and 64; paragraphs 0322-0324). Stender et al. also teach hybridization solutions including 20% formamide (paragraphs 0279 and 0336). Stender et al. also teach that lower stringency, which is achieved by lowering the concentration of formamide, has the added advantage of allowing the use of shorter probes (paragraph 0390). Thus, Stender et al. teach the known techniques discussed above. Stender et al. do not teach the claimed molecular weight of dextran sulfate or the specific, lowered range of formamide. However, Kato et al. teach methods and compositions for probe hybridization at low stringency comprising the use of dextran sulfate having a molecular weight of about 500,000 (i.e., 500kDA; paragraph 0132), as well as the use of 15% formamide and bovine serum albumin (i.e., claim 73; paragraph 0134) and 1 hour hybridization times (paragraph 0197). Thus, Kato et al. teach the known techniques discussed above. In addition, Vogelstein et al. teach hybridization methods and compositions comprising 10% formamide in a one hour time frame (column 12, line 60-column 13, line 20), that further utilize high molecular weight (e.g., 1,000,000 Daltons) dextran sulfate (column 10, lines 20-40), and that the methods have the added advantage of allowing detection of any target nucleic acids of mutant sequences associated with benign as well as malignant neoplasms in stool samples (column 3, lines 10-25). Thus, Vogelstein et al. teach the known techniques discussed above. In addition, with respect to the multiple ranges found within the instant claims, the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). The courts have found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Therefore, the claimed ranges alternatively represent routine optimization and/or an obvious variant of the values taught by the prior art. MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, counsel’s mere arguments cannot take the place of evidence in the record. It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of the cited prior art to arrive at the instantly claimed composition with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a composition having the added advantages of utilizing components well known in the art as having the added advantages of: A. Allowing the use of shorter probes (paragraph 0390) via low stringency conditions as explicitly taught by Stender et al. (paragraph 0390); Achieving the low stringency desired by Stender et al. by using the guidelines set forth in Kato et al. (paragraph 0132 and 0134); and Allowing detection of any target nucleic acids of mutant sequences associated with benign as well as malignant neoplasms in stool samples as explicitly taught by Vogelstein et al. (column 3, lines 10-25). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in useful methods of using the claimed hybridization compositions. Regarding claims 65 and 71, the method of claim 63 is discussed above. Stender et al. teach 20% dextran sulfate (paragraph 0324). Regarding claims 66-68, the method of claim 65 is discussed above. Stender et al. teach 500 mM NaCl (paragraph 0208 and 0281). Kato et al. teach 1 M salt (paragraph 0134), and Vogelstein et al. teach 0.9 M NaCl ( column 12, line 60-column 13, line 20). Regarding claims 70 and 72, the method of claim 63 is discussed above. Stender et al. also teach the solution includes polyvinylpyrrolidone, chelating agents (i.e., EDTA), detergents (i.e., SDS), and a buffer (i.e., Tris; paragraphs 0324 and 0355), as well as glycols (paragraph 0279). Kato et al. teach PVP (paragraph 0215), BSA (paragraph 0134), glycols (paragraph 0132), as well as buffers (i.e., NaHPO4) and detergents (i.e., SDS), and chelating agents (i.e., EDTA; paragraph 0134). Vogelstein et al. teach PVP, BSA, buffers (i.e., sodium citrate) detergents (i.e., SDS), and chelating agents (i.e., EDTA; column 10, lines 20-40), as well as glycols (column 12, line 60-column 13, line 20). In addition, it is reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Therefore, the claimed ranges alternatively represent routine optimization and/or an obvious variant of the values taught by the prior art. Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record. Regarding claim 74, the method of claim 63 is discussed above. Kato et al. teach 15% formamide and bovine serum albumin (paragraph 0134). In addition, it is reiterated that while Stender et al. teach hybridization solutions including 20% formamide (paragraphs 0279 and 0336), Stender et al. also teach that lower stringency, which is achieved by lowering the concentration of formamide, has the added advantage of allowing the use of shorter probes (paragraph 0390). It is also reiterated that Vogelstein et al. teach hybridization methods and compositions comprising 10% formamide in a one hour time frame (column 12, line 60-column 13, line 20), and that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Therefore, the claimed ranges alternatively represent routine optimization and/or an obvious variant of the values taught by the prior art. Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record. Double Patenting 10. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 11. Claims 63-68 and 70-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29, 31-40, 42-45, and 47-52 of U.S. Patent No. 9,297,035 in view of Stender et al. ((U.S. Patent Application Publication No. US 2002/0137035 A1, published 26 September 2002), Kato et al. (U.S. Patent Application Publication No. US 2005/0044582 A1, published 24 February 2005) and/or Vogelstein et al. (U.S. Patent No. 5,910,407, issued 8 June 1999). Both sets of claims are drawn to hybridizing nucleic acids in less than 4 hours, dextran sulfate concentrations, NaCl, glycols, accelerating agents, etc. Any additional limitations of the ‘035 claims are encompassed by the open claim language “comprising” found in the instant claims. The “035 claims do not recite the hybridization times or the claimed molecular weight of dextran sulfate. However, these limitations, along with the additional limitations and the rationale for combining, are discussed above. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a composition having the added advantages of utilizing components well known in the art as having the added advantages of: A. Allowing the use of shorter probes (paragraph 0390) via low stringency conditions as explicitly taught by Stender et al. (paragraph 0390); Achieving the low stringency desired by Stender et al. by using the guidelines set forth in Kato et al. (paragraph 0132 and 0134); and Allowing detection of any target nucleic acids of mutant sequences associated with benign as well as malignant neoplasms in stool samples as explicitly taught by Vogelstein et al. (column 3, lines 10-25). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in useful methods of using the claimed hybridization compositions. 12. Claims 63-68 and 70-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 11-54 of U.S. Patent No. 9,303,287 in view of Stender et al. ((U.S. Patent Application Publication No. US 2002/0137035 A1, published 26 September 2002), Kato et al. (U.S. Patent Application Publication No. US 2005/0044582 A1, published 24 February 2005) and/or Vogelstein et al. (U.S. Patent No. 5,910,407, issued 8 June 1999). Both sets of claims are drawn to hybridizing nucleic acids in less than 4 hours, dextran sulfate concentrations, NaCl, glycols, accelerating agents, etc. Any additional limitations of the ‘287 claims are encompassed by the open claim language “comprising” found in the instant claims. The ‘287 claims do not recite the claimed molecular weight of dextran sulfate or amount of formamide. However, the molecular weight and formamide amounts, as well as additional claimed limitations and the rationale for combining with Stender et al. with Kato et al. and/or Vogelstein et al. are discussed above. 13. Claims 63-68 and 70-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 and 38-61 of U.S. Patent No. 9,309,562 in view of Stender et al. ((U.S. Patent Application Publication No. US 2002/0137035 A1, published 26 September 2002), Kato et al. (U.S. Patent Application Publication No. US 2005/0044582 A1, published 24 February 2005) and/or Vogelstein et al. (U.S. Patent No. 5,910,407, issued 8 June 1999). Both sets of claims are drawn to hybridizing nucleic acids in less than 4 hours, dextran sulfate concentrations, NaCl, glycols, accelerating agents, etc. Any additional limitations of the ‘562 claims are encompassed by the open claim language “comprising” found in the instant claims. The ‘562 claims do not recite the claimed molecular weight of dextran sulfate or formamide amounts. However, the molecular weight and formamide amounts, as well as additional claimed limitations and the rationale for combining with Stender et al. with Kato et al. and/or Vogelstein et al. are discussed above. 14. Claims 63-68 and 70-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9-19 of U.S. Patent No. 10,202,638 in view of Stender et al. ((U.S. Patent Application Publication No. US 2002/0137035 A1, published 26 September 2002), Kato et al. (U.S. Patent Application Publication No. US 2005/0044582 A1, published 24 February 2005) and/or Vogelstein et al. (U.S. Patent No. 5,910,407, issued 8 June 1999). Both sets of claims are drawn to hybridizing nucleic acids in less than 4 hours, dextran sulfate concentrations, NaCl, glycols, accelerating agents, etc. Any additional limitations of the ‘638 claims are encompassed by the open claim language “comprising” found in the instant claims. The ‘638 claims do not recite the claimed molecular weight of dextran sulfate or formamide amounts. However, the molecular weight and amount of formamide, as well as additional claimed limitations and the rationale for combining with Stender et al. with Kato et al. and/or Vogelstein et al. are discussed above. 15. Claims 63-68 and 70-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 12-16, and 18-20 of U.S. Patent No. 11,118,226 in view of Stender et al. ((U.S. Patent Application Publication No. US 2002/0137035 A1, published 26 September 2002), Kato et al. (U.S. Patent Application Publication No. US 2005/0044582 A1, published 24 February 2005) and/or Vogelstein et al. (U.S. Patent No. 5,910,407, issued 8 June 1999). Both sets of claims are drawn to hybridizing nucleic acids in less than 4 hours, dextran sulfate concentrations, NaCl, glycols, accelerating agents, etc. Any additional limitations of the ‘226 claims are encompassed by the open claim language “comprising” found in the instant claims. The ‘226 claims do not recite the claimed hybridization times, formamide amounts, or the claimed molecular weight of dextran sulfate. However, the hybridization times, formamide amounts, the molecular weight, and the additional claimed limitations and the rationale for combining with Stender et al. with Kato et al. and/or Vogelstein et al. are discussed above. 16. Claims 63-68 and 70-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-19 of U.S. Patent No. 11,834,703 in view of Stender et al. ((U.S. Patent Application Publication No. US 2002/0137035 A1, published 26 September 2002), Kato et al. (U.S. Patent Application Publication No. US 2005/0044582 A1, published 24 February 2005) and/or Vogelstein et al. (U.S. Patent No. 5,910,407, issued 8 June 1999). Both sets of claims are drawn to formamide, dextran sulfate concentrations, NaCl, glycols, accelerating agents, etc. Any additional limitations of the ‘703 claims are encompassed by the open claim language “comprising” found in the instant claims. The ‘703 claims do not recite the claimed hybridization times, formamide amounts, or the claimed molecular weight of dextran sulfate. However, the hybridization times, formamide amounts, the molecular weight, and the additional claimed limitations and the rationale for combining with Stender et al. with Kato et al. and/or Vogelstein et al. are discussed above. 17. Claims 63-68 and 70-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,795,499 in view of Stender et al. ((U.S. Patent Application Publication No. US 2002/0137035 A1, published 26 September 2002), Kato et al. (U.S. Patent Application Publication No. US 2005/0044582 A1, published 24 February 2005) and/or Vogelstein et al. (U.S. Patent No. 5,910,407, issued 8 June 1999). Both sets of claims are drawn to hybridizing nucleic acids in less than 4 hours, dextran sulfate concentrations, NaCl, accelerating agents, etc. Any additional limitations of the ‘499 claims are encompassed by the open claim language “comprising” found in the instant claims. The ‘499 claims do not recite the claimed molecular weight of dextran sulfate or formamide amounts. However, the molecular weight and formamide amounts, as well as additional claimed limitations and the rationale for combining with Stender et al. with Kato et al. and/or Vogelstein et al. are discussed above. 18. Claims 63-68 and 70-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,534,755 in view of Stender et al. ((U.S. Patent Application Publication No. US 2002/0137035 A1, published 26 September 2002), Kato et al. (U.S. Patent Application Publication No. US 2005/0044582 A1, published 24 February 2005) and/or Vogelstein et al. (U.S. Patent No. 5,910,407, issued 8 June 1999). Both sets of claims are drawn to hybridizing nucleic acids, times under 4 hours,, dextran sulfate concentrations, NaCl, accelerating agents, etc. Any additional limitations of the ‘755 claims are encompassed by the open claim language “comprising” found in the instant claims. The ‘755 claims do not recite the claimed molecular weight of dextran sulfate or formamide amounts. However, the molecular weight and formamide amounts, as well as additional claimed limitations and the rationale for combining with Stender et al. with Kato et al. and/or Vogelstein et al. are discussed above. 19. Claims 63-68 and 70-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 61-70 and 72-74 of copending Application No. 19/035,623 in view of Stender et al. ((U.S. Patent Application Publication No. US 2002/0137035 A1, published 26 September 2002), Kato et al. (U.S. Patent Application Publication No. US 2005/0044582 A1, published 24 February 2005) and/or Vogelstein et al. (U.S. Patent No. 5,910,407, issued 8 June 1999). Both sets of claims are drawn to hybridizing nucleic acids, dextran sulfate concentrations, 10-20% formamide, NaCl, accelerating agents, etc. Any additional limitations of the ‘623 claims are encompassed by the open claim language “comprising” found in the instant claims. The ‘623 claims do not recite the claimed hybridization times or the claimed molecular weight of dextran sulfate. However, the hybridization times, the molecular weight, and the additional claimed limitations and the rationale for combining with Stender et al. with Kato et al. and/or Vogelstein et al. are discussed above. This is a provisional nonstatutory double patenting rejection. 20. Claims 63-68 and 70-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of copending Application No. 19/514,114 in view of Stender et al. ((U.S. Patent Application Publication No. US 2002/0137035 A1, published 26 September 2002), Kato et al. (U.S. Patent Application Publication No. US 2005/0044582 A1, published 24 February 2005) and/or Vogelstein et al. (U.S. Patent No. 5,910,407, issued 8 June 1999). Both sets of claims are drawn to hybridizing nucleic acids, buffers, salts chelating agents, detergents, etc. Any additional limitations of the ‘114 claims are encompassed by the open claim language “comprising” found in the instant claims. The ‘114 claims do not recite the claimed formamide or the claimed molecular weight of dextran sulfate. However, the formamide, the molecular weight, and the additional claimed limitations and the rationale for combining with Stender et al. with Kato et al. and/or Vogelstein et al. are discussed above. This is a provisional nonstatutory double patenting rejection. 21. Claims 63-68 and 70-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of copending Application No. 19/514,147 in view of Stender et al. ((U.S. Patent Application Publication No. US 2002/0137035 A1, published 26 September 2002), Kato et al. (U.S. Patent Application Publication No. US 2005/0044582 A1, published 24 February 2005) and/or Vogelstein et al. (U.S. Patent No. 5,910,407, issued 8 June 1999). Both sets of claims are drawn to hybridizing nucleic acids, buffers, salts chelating agents, detergents, etc. Any additional limitations of the ‘147 claims are encompassed by the open claim language “comprising” found in the instant claims. The ‘147 claims do not recite the claimed formamide or the claimed molecular weight of dextran sulfate. However, the formamide, the molecular weight, and the additional claimed limitations and the rationale for combining with Stender et al. with Kato et al. and/or Vogelstein et al. are discussed above. This is a provisional nonstatutory double patenting rejection. Information Disclosure Statement 22. The Information Disclosure Statement filed 23 July 2026 is acknowledged and considered. Response to Arguments 23. Applicant's arguments filed 23 July 2026 (hereafter the “Remarks”) have been fully considered but are moot in view of the new rejections necessitated by the amendments. It is noted, however, that Applicant argues on pages 5-6 of the Remarks that the “endpoint” 20% range of Stender et al. does not render the amended range obvious. This argument is unconvincing, because, as noted in the rejections above, Stender et al. explicitly teach that lower stringency, which is achieved by lowering the concentration of formamide, has the added advantage of allowing the use of shorter probes (paragraph 0390). Thus, Stender et al. clearly teach a motivation for going lower than 20% formamide. Conclusion 24. No claim is allowed. 25. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30. 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, Anne Gussow can be reached at 571-272-6047. 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. Robert T. Crow Primary Examiner Art Unit 1683 /Robert T. Crow/Primary Examiner, Art Unit 1683
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Prosecution Timeline

Jan 26, 2024
Application Filed
Mar 27, 2026
Non-Final Rejection mailed — §103, §DP
May 29, 2026
Response Filed
Jun 15, 2026
Final Rejection mailed — §103, §DP
Jul 23, 2026
Request for Continued Examination
Jul 27, 2026
Response after Non-Final Action
Aug 05, 2026
Non-Final Rejection mailed — §103, §DP (current)

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Prosecution Projections

3-4
Expected OA Rounds
42%
Grant Probability
74%
With Interview (+32.1%)
3y 11m (~1y 5m remaining)
Median Time to Grant
High
PTA Risk
Based on 715 resolved cases by this examiner. Grant probability derived from career allowance rate.

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