Prosecution Insights
Last updated: May 29, 2026
Application No. 18/095,982

INTEGRATED PURIFICATION AND MEASUREMENT OF DNA METHYLATION AND CO-MEASUREMENT OF MUTATIONS AND/OR MRNA EXPRESSION LEVELS IN AN AUTOMATED REACTION CARTRIDGE

Non-Final OA §112§DOUBLEPATENT§DP
Filed
Jan 11, 2023
Priority
Jun 15, 2015 — provisional 62/175,916 +1 more
Examiner
GORDON, BRIAN R
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Cepheid
OA Round
1 (Non-Final)
65%
Grant Probability
Moderate
1-2
OA Rounds
0m
Est. Remaining
84%
With Interview

Examiner Intelligence

Grants 65% of resolved cases
65%
Career Allowance Rate
617 granted / 952 resolved
At TC average
Strong +19% interview lift
Without
With
+18.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
30 currently pending
Career history
1002
Total Applications
across all art units

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
54.6%
+14.6% vs TC avg
§102
18.4%
-21.6% vs TC avg
§112
14.3%
-25.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 952 resolved cases

Office Action

§112 §DOUBLEPATENT §DP
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 . Specification The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. The abstract of the disclosure is objected to because abstract includes legal phraseology and exceeds the word limit. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Drawings The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the each of the recited positively claimed structural elements recited in each of the claims must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The examiner fails to locate corresponding reference numerals or labeling in the specification and drawings for each of the elements provided for in the claims. Therefore, it is unclear what structures disclosed in the specification and drawings correspond to each of the elements recited in the claims. Therefore, it is hereby requested that applicant provide for what/which structures disclosed in the specification and drawings correspond to each and all of the elements recited in the claims. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Interpretation Content of Specification (k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p). The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”. A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus. It is noted that the claims are directed to an apparatus defined by the positively claimed structural elements listed in the body of the claims. . Claim 92 mentions a nucleic acid, sample, bisulfite conversion reagent. deaminated nucleic acid, converted nucleic acid, bisulfite reagent, desulphonation/elution buffer, microfluidic channels, valves, central valve, plunger, fluid, bisulfite, reagent mix, catalyst, and scavengers. However, none of such are positively claimed (listed on separate indented lines) as structural elements of the invention. All of such are articles and/or materials that are intended to be, can be worked upon and/or used with the apparatus. If applicant intends for any of the prior to be elements of the invention, then the claim should clearly positively claim, list such as elements of the apparatus. There is no requirement for the apparatus to be used in any process to perform any acts, steps including any determining, sample receiving, controlling temperature, thermocycling, heating, amplifying, converting, reacting, desulphonating, drawing, nor anything else. It is noted that the various “for”, “that can be”, “to…”, “configured to…”, and other similar clauses are directed to intended use and what can be done. Such clauses do not provide for any further structural elements of the apparatus. Intended/possible uses are not structural elements. An owner, operator, user, etc. of the apparatus can choose to use the apparatus as one so desires, or not use the apparatus at all. It is noted that the various “when” clauses such as “when in use…”; “when present”; and any other similar clauses are directed to conditions that are not required to occur. The claims are directed to an apparatus not a process. There is no requirement for any use, nor any substance, material, structure, etc. that is not positively claimed an element of the apparatus to ever be present. Such clauses recited throughout the claims do not provide for any further structural element of the apparatus. In claim 103, the second matrix material (second column) is not required to be present. It is noted that the cartridge is never required to comprise the recited structures, samples, reagents, buffer, rinse solution, PCR primers/probes, PCR enzymes, etc. recited in claims 112-113 and 118-119 because the cartridge is never required to be in use to do anything. It is noted that the terms “or”, “and/or” (minimally means “or”), and “optionally” are directed to alternatives and/or options that are not requirements. It is noted that the terms “plurality”, “at least two, and nouns ending in “s” only requires two. It is noted that the phrase “at least one” and “one or more” only requires one. 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 92-95, 98-100, 103-105, and 112-121 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 92 recites the limitation " the methylation state of a nucleic acid" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. As to claim 92, it is unclear what is the nexus of “a plurality of chambers containing reagents and/or buffers” to previously recited “sample receiving chamber” and chamber in the phrase “a reaction channel or chamber…” because the claim does not clearly indicate such. It is presumed that the last phrase is intended to be “a reaction channel or reaction chamber” to provide for proper, clear antecedent basis for the later recited phrase “the reaction chamber”. Consistent terminology should be employed throughout the claims. However, it is noted that the respective names of the chambers (and other structures) do not provide for any structural distinctions of any chambers. For example, the terms “sample receiving” and “reaction” appear to be directed to the intended use of such chambers. As to claims 92, it is unclear which/what chambers are being referenced by the phrase “said chambers” because the claim previously recites different chambers. See above. Furthermore, it is noted that there is no requirement for anything to be in use, so there is no requirement for any chamber to contain a bisulfite reagent and desulphonation elution buffer. Claim 92 recites the limitation "said columns" in the next-to-last paragraph. There is insufficient antecedent basis for this limitation in the claim. Only one column has been previously claimed. It is presumed that the phrase “said channel ore chamber” is intended to refer to “said reaction channel or reaction chamber”. If so, the claim should clearly recite such. See rejection/remarks above. As to claim 92, in the next to last paragraph, it is unclear if it is intended for the cartridge to comprise a plurality of microchannels, valves, and a central valve comprising a channel, because the claim does not clearly list, positively claim such as structural elements. However, it is unclear what is the nexus of valves and central valve…if the valves include the central valve because the claim does not clearly recite such. Furthermore, it is unclear what is structurally required of a valve to be “central” because the claim does not provide for such. The term “disposed around” in claim 92 is a relative term which renders the claim indefinite. The term “disposed around” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term does not provide for any definitive structural nexus, connectivity, distance, definitive relative location of any structures. Structures can be at any distance away from each other or some relative location and subjectively be considered as being “disposed around” each other. What may be considered as disposed around to one person may not be considered as such to another and vice versa. Furthermore, it is unclear what is the nexus of “a chamber” to previously recited different chambers. It is unclear if such “a chamber” is the same as, amongst, or different from the number of previously recited chambers (sample receiving chamber, reaction chamber, plurality of chambers, said chambers, etc.). Also applicable to “a chamber” recited in claim 93. It is noted that last paragraph of the claim is an option, therefore there is no requirement for any second column to be present. Furthermore, even if desired to be present, the claim does not provide for any structural nexus, connectivity of such second column to any prior positively claimed structural element. Claim 92 recites the limitation "said second matrix material" in the last 2 lines. There is insufficient antecedent basis for this limitation in the claim. Dependent claims 93-95, 98-100, 103-105, and 112-121 are rejected via dependency upon a rejected claim. It is noted that claim 93, is only further structurally limiting if the cartridge is in use as indicated by the “when in use” clause. No use of the apparatus to do anything is ever required to occur. Therefore, there is no requirement for any chamber to contain a reagent comprising guanidinium thiocyanate ethanol (GTC-EtOH). It is unclear what is further structurally required by claims 98-100 because the bisulfate conversion reagent, bisulfite in a reagent mix, scavengers and catalyst… are not structural elements of the invention. See remarks above. It is noted that reciting “said bisulfite is provided in a reagent mix comprising scavengers…” does not required such mixture to be present as an element of, present within any claimed structure of the cartridge. Claim 100 contains the trademark/trade name Trolox. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a scavenger, compound and, accordingly, the identification/description is indefinite. As to claims 104-105 and 120-121, it is unclear what is the nexus of “one or more chambers” and “at least two chambers” to each other and the previously recited different chambers. It is unclear if such “one or more chambers” and “at least two chambers” are the same as, amongst, or different from the number of previously recited chambers (sample receiving chamber, reaction chamber, plurality of chambers, said chambers, etc.). It is unclear what is PCR because such is not defined in the claim. Claims 113 and 116-117 contains the trademark/trade name Tween. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a chemical/reagent and, accordingly, the identification/description is indefinite. As to claims 114 and 116, it is unclear what is structurally required by the “configured for…” clauses because the phrases do not provide for any further structure, but are directed to intended possible uses of the apparatus, cartridge. There is no requirement for any bisulfite reagent, sample, and GTC-ETOH-Tween (see also claim 117) to ever be added/provided to any structural element of the cartridge at any time. It is presumed that “the bisulfite reagent” in claims 114-115 is intended to refer to the bisulfite conversion reagent. Therefore, the claims should clearly recite such. Claims 114 and 116 recite the limitations “the time the sample is placed in the cartridge” and "the time the sample is placed into the cartridge” There is insufficient antecedent basis for these limitations in the claims. No placing of any sample in any element of the cartridge at any time is required to be performed. The term “near” in claims 114 and 116 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although no placing of the sample in the cartridge is required to be performed at any time, there is no indication as what amounts of time for a time of placing a sample in the cartridge are considered as “near” the time of placing the sample in the cartridge. Claim 117 recites the limitation "the GTC-ETOH-Tween buffer". There is insufficient antecedent basis for this limitation in the claim. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 92-95, 98-100, 103-105, and 112-121 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,539,510. Although the claims at issue are not identical, they are not patentably distinct from each other because claim of the patent provides for each of the same structural elements or equivalents of the elements of the instant claims. The claims of the patent are: 1. A cartridge for determining a methylation state of a nucleic acid, said cartridge comprising: (i) a first column comprising a first matrix material, (a column comprising a first matrix material) (ii) a sample receiving chamber, (a sample receiving chamber) (iii) a reaction channel or chamber that can be temperature controlled, (a reaction chamber) (iv) a plurality of chambers for containing reagents and/or buffers, (a plurality of chambers containing reagents and/or buffers) wherein: at least one of said chambers is configured to contain a bisulfite reagent, and at least one of said chambers is configured to contain a desulphonation/elution buffer, wherein said cartridge optionally comprises a second column comprising a second matrix material, (wherein said cartridge optionally comprises a second column comprising said second matrix material) wherein said sample receiving chamber, said first and optional second column(s), said plurality of chambers, and said temperature-controlled heating channel or chamber, are selectively in fluid communication by microfluidic channels and valves, and wherein: said sample receiving chamber, said first and optional second column(s), said plurality of chambers, and said reaction channel or chamber or a port into said reaction channel or chamber, are disposed around a central valve and selectively in fluid communication with a channel in said central valve, wherein said central valve is configured to accommodate a plunger that is capable of drawing fluid into or out of a chamber in fluid communication with said central valve, and/or said cartridge is configured to perform bisulfite conversion in the reaction channel or chamber, which can be subjected to thermocycling and later used for amplification of converted nucleic acid by polymerase chain reaction (PCR). (the “wherein” clauses above are the same and or provide for the same scope/recitations as the “wherein” clauses of instant claim 92 and further dependent claims of the instant application). 2. The cartridge of claim 1, wherein said sample receiving chamber, said first and optional second column(s), said plurality of chambers, and said reaction channel or chamber or a port into said reaction channel or chamber, are disposed around a central valve and selectively in fluid communication with a channel in said central valve, wherein said central valve is configured to accommodate a plunger that is capable of drawing fluid into or out of a chamber in fluid communication with said central valve. 3. The cartridge of claim 1, wherein said cartridge is configured to perform bisulfite conversion in the reaction channel or chamber, which can be subjected to thermocycling and later used for amplification of converted nucleic acid by polymerase chain reaction (PCR). 4. The cartridge of claim 1, wherein: said sample receiving chamber, said first and optional second column(s), said plurality of chambers, and said reaction channel or chamber or a port into said reaction channel or chamber, being disposed around a central valve and selectively in fluid communication with a channel in said central valve, wherein said central valve is configured to accommodate a plunger that is capable of drawing fluid into or out of a chamber in fluid communication with said central valve, and said cartridge is configured to perform bisulfite conversion in the temperature controlled channel or chamber, which can be subjected to thermocycling and later used for amplification of converted nucleic acid by polymerase chain reaction (PCR). 5. The cartridge of claim 1, wherein said cartridge comprises a chamber configured to contain a reagent comprising guanidinium thiocyanate ethanol (GTC-EtOH). 6. The cartridge of claim 1, wherein said second column is absent. 7. The cartridge of claim 1, wherein said reaction channel or chamber is a channel or chamber that can be subjected to thermocycling. 8. The cartridge of claim 1 wherein said bisulfite reagent comprises a compound selected from the group consisting of ammonium bisulfite sodium, metabisulfite, potassium bisulfite, cesium bisulfite, and 1,4-diazoniabicyclo[2.2.2]octane-1,4-disulfinate (DABSO). 9. The cartridge of claim 1, wherein said cartridge comprises one, two, or more chambers containing one or more reagents selected from the group consisting of methylation specific PCR primers, methylation specific PCR probes, PCR enzyme(s), and PCR reaction buffer. 10. The cartridge of claim 1, wherein: said cartridge contains at least one chamber containing primers and probes for detection of methylation of a forward strand of a converted DNA; and/or said cartridge contains at least one chamber containing primers and probes for detection of methylation of a reverse strand of a converted DNA. 11. The cartridge of claim 9, wherein said PCR primers, and/or said probes, and/or enzymes are provided as beads. 12. The cartridge of claim 1, wherein said cartridge is configured to comprise: a first chamber containing a sample, that optionally comprises a GTC-EtOH-Tween extraction/precipitation reagent; a second chamber containing a guanidinium thiosulfate-ethanol (GTC-EtOH) solution; a third chamber containing a bisulfite reagent; a fourth chamber containing a buffer; a fifth chamber containing a rinse solution; and a sixth chamber containing an elution/desulphonation reagent. 13. The cartridge of claim 1, wherein: the cartridge is configured for the bisulfite reagent to be added to the cartridge by the user; and/or the cartridge is configured for addition of said GTC-ETOH-Tween buffer by the user. 14. The cartridge of claim 1, wherein: the bisulfite reagent is provided as a component of the cartridge; and/or the GTC-ETOH-Tween buffer is provided as a component of the cartridge. 15. The cartridge of claim 12, wherein said cartridge comprises a seventh chamber containing PCR primers and/or probes and/or PCR enzymes. 16. The cartridge of claim 1, wherein: said cartridge comprises one or more chambers containing primers specific for bisulfite converted methylated and/or unmethylated sequences; and/or said cartridge comprises one or more chambers containing reagents for TaqMan PCR reactions; and/or said cartridge comprises one or more chambers containing one or more fluorescent probes that are markers for amplified methylated sequences and/or one or more fluorescent probes that are markers for amplified unmethylated sequences. Claims 92, 95, 98-100, 104-105, and 114-115, and 120 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,260,387. Although the claims at issue are not identical, they are not patentably distinct from each other because claim of the patent provides for each of the structural elements or equivalents of the elements of the instant claims. The claims of the patent are: A set of cartridges for determining the methylation state of a nucleic acid, said set of cartridges comprising: a first cartridge comprising: a sample receiving chamber; (a sample receiving chamber) a column comprising a first matrix material; (a column comprise a first matrix material) a temperature controlled channel or chamber; (a reactions channel) a sample removal chamber; and a plurality of chambers containing reagents and/or buffers, (a plurality of chambers, at least one of said chambers contains a bisulfate reagent, buffer…see also further recitations below in this claims and further dependent claims) the sample receiving chamber, the column, the temperature controlled channel or chamber or a port into the temperature controlled channel or chamber, the sample removal chamber, and the plurality of chambers are disposed around a central valve and selectively in fluid communication with one or more channels in the central valve, wherein at least one of said plurality of chambers in the first cartridge is configured to contain a conversion reagent; and a second cartridge comprising: a sample receiving chamber; a column comprising a second matrix material; a temperature controlled channel or chamber; and a plurality of chambers containing reagents and/or buffers, the sample receiving chamber, the column, the temperature controlled channel or chamber or a port into the temperature controlled channel or chamber, and the plurality of chambers are disposed around a central valve and selectively in fluid communication with one or more channels in the central valve, wherein at least one of said plurality of chambers in the second cartridge is configured to contain a desulphonation and/or elution reagent. (the “wherein” clauses above are the same and/or provide for the same scope/recitations as the “wherein” clauses of instant claim 92 and further dependent claims of the instant application). 2. The set of cartridges of claim 1, wherein the temperature controlled channel or chamber in said first cartridge is a thermocycling channel or chamber. 3. The set of cartridges according to claim 1, wherein the temperature controlled channel or chamber in said second cartridge is a thermocycling channel or chamber. 4. The set of cartridges according to claim 1, wherein said conversion reagent, comprises a compound selected from the group consisting of ammonium bisulfite, sodium metabisulfite, potassium bisulfite, cesium bisulfite, and 1,4-diazoniabicyclo[2.2.2]loctane-1,4-disulphinate (DABSO). 5. The set of cartridges of claim 4, wherein said conversion reagent, comprises ammonium bisulfite. 6. The set of cartridges according to claim 1, wherein said conversion reagent, is provided in a reagent mix comprising scavengers to prevent sulfite oxidation and/or catalysts. 7. The set of cartridges of claim 6, wherein said conversion reagent, is provided in a reagent mix comprising scavengers selected from the group consisting of TROLOX water-soluble analog of vitamin E and hydroquinone. 8. The set of cartridges according to claim 6, wherein said conversion reagent, is provided in a reagent mix comprising polyamines as catalysts. 9. The set of cartridges according to claim 1, wherein said first cartridge is configured for the conversion reagent to be added to the cartridge by the user. 10. The set of cartridges according to claim 1, wherein the conversion reagent is provided as a component in one of said plurality of chambers in said first cartridge. 11. The set of cartridges according to claim 1, wherein at least one chamber of the plurality of chambers in said second cartridge contains PCR primers, and/or PCR probes, and/or a PCR master mix. 12. The set of cartridges according to claim 1, wherein the plurality of chambers in said second cartridge comprises one or more chambers containing one or more reagents selected from the group consisting of methylation specific PCR primers, methylation specific PCR probes, PCR enzyme(s), and PCR reaction buffer. 13. The set of cartridges of claim 12, wherein the plurality of chambers in said second cartridge comprises at least two chambers containing one or more reagents selected from the group consisting of methylation specific PCR primers, methylation specific PCR probes, PCR enzyme(s), and PCR reaction buffer. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. VANDER HORN; Peter B. et al.; MILLER; Oliver et al.; and Dority; Douglas B. et al. discloses devices comprising columns, channels, and/or chambers. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday.. 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, Charles Capozzi can be reached at 571-270-3638. 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. /BRIAN R GORDON/Primary Examiner, Art Unit 1798
Read full office action

Prosecution Timeline

Jan 11, 2023
Application Filed
May 07, 2026
Non-Final Rejection mailed — §112, §DOUBLEPATENT, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
65%
Grant Probability
84%
With Interview (+18.7%)
3y 2m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 952 resolved cases by this examiner. Grant probability derived from career allowance rate.

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