Prosecution Insights
Last updated: April 19, 2026
Application No. 18/172,685

DEVICE FOR TESTING OF AN ENVIRONMENTAL SAMPLE

Non-Final OA §102§103
Filed
Feb 22, 2023
Examiner
WRIGHT, PATRICIA KATHRYN
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
BECTON, DICKINSON AND COMPANY
OA Round
1 (Non-Final)
66%
Grant Probability
Favorable
1-2
OA Rounds
3y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allow Rate
599 granted / 912 resolved
+0.7% vs TC avg
Strong +42% interview lift
Without
With
+42.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
36 currently pending
Career history
948
Total Applications
across all art units

Statute-Specific Performance

§101
1.9%
-38.1% vs TC avg
§103
35.4%
-4.6% vs TC avg
§102
26.2%
-13.8% vs TC avg
§112
30.2%
-9.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 912 resolved cases

Office Action

§102 §103
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 Election/Restrictions Claims 24-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 05, 2025. Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i). Claims 24-39 are directed to a method of detecting which is currently distinct from the device claims 1-23 for the reasons set forth in the restriction filed September 05, 2025. The examiner does not recommend canceling the method claims should the device claim 1 become allowable, since at that time the Office will consider rejoining the withdrawn method claims should they include the allowable subject matter of the device. Claim Interpretation The instant device claims contain a large amount of functional/process and/or intended use language. In device/apparatus claims functional/process limitations state either an intended use or operation, a manner of operating a device, apparatus or system, or what the apparatus/device does. Apparatus claims cover what a device is, not what a device does. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). In the patentability analysis of instant device claims, aspects or limitations that have been interpreted by the examiner as functional are generally italicized whereas aspects interpreted as structural components are normally bolded. The bold font and italics are shown when the structure and function are initially introduced though not necessarily repeated, particularly in dependent claims. The examiner applies this formatting for both the examiner and applicant’s convenience. However, absent the referenced typestyles, the patentability analysis will still be clear regarding which limitations the examiner interprets as structural versus functional. Of course, in the patentability analysis of these device claims, functional/process/intended use features have not been ignored by the examiner, and applicant can and should employ such language where appropriate and helpful. However, if a prior art structure is capable of performing the intended use, or if such apparatus can operate in the manner described, then it meets the claim limitation (MPEP §§ 2114, 2173.05(g)). In summary, while features of a device may be recited either structurally or functionally, claims directed to an apparatus should be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). The examiner's referral to Applicant's specification will generally pertain to the corresponding PG published application US 2023/0194387; hereinafter ‘387. The below patentability analysis provides one or more interpretations and claim mappings of the claimed structures and/or limitations although other interpretations may be possible. In the patentability analysis, the examiner has applied the broadest reasonable interpretation (BRI) consistent with the specification. However, the specific limitations from the specification have not been read into the claims. See MPEP §§2111 and 2173.01 I. The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: i. “valve assembly” in claim 1 has been interpreted by the examiner as including a one-way valve configured to allow the fluid sample and the gas generated in the reagent well to move from the reagent well towards the test well, and to prevent the fluid sample and the gas generated in the reagent well from moving upstream of the one-way valve (see para [0010] of ‘387) or structural equivalents thereof. ii. “heating element substrate” in claim 19 has been interpreted as comprising a heat activation reservoir, wherein a top surface of the heat activation reservoir is generally coplanar with the top surface of the test well and the top surface of the control well, the heat activation reservoir configured to receive an activation agent through the access window and the heating element substrate includes a heating element cavity positioned below the test well and the control well, the heating element cavity comprising an exothermic heating material configured to generate heat when exposed to the activation agent is added to the heat activation reservoir or structural equivalents thereof (see para [0015] of ’387). Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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. Claims 1-10 and 14-18 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Battrell et al., (WO 2013/106458; hereinafter “Battrell”). Regarding claim 1, Battrell teaches a detection device (microfluidic device) for detecting an analyte in a fluid sample comprising: a sample reservoir (54; in Fig. 3) in fluid communication with a fluid flow path channels, wherein the fluid flow path comprises; a control well 43 downstream of the sample reservoir (Battrell teaches assay chamber 43, shown at least in Fig. 3 two control test fields (positive 44 and negative 45 , see also FIG. 10)); a valve assembly (46,47) where at least valve 46 is shown in Fig. 3 as downstream of the control well (Battrell- see Figs 3 and 4-5B); a reagent well downstream of the valve assembly 47, the reagent well comprising a reducing agent dried therein (Battrell teaches prior to assembly, reagents can be applied in or on microfluidic channels (including microchannel 49 and test fields in a variety of ways. Various "printing" techniques are suitable for application of liquid reagents to layers of the device, e.g., micro-syringes, pens using metered pumps, direct printing, ink-jet printing, air-brush, and contact (or filament) methods, and the layers or sheets are then assembled into the completed device, so the reagents are reasonably considered dried); and a test well (assay chamber 43) downstream of the reagent well (see Fig. 3 for example). Note: the examiner has interpreted the claimed “flow path” comprising every element in fluid communication with the sample reservoir and capable of fluid flow, which includes in Battrell at least the channels 48, 49, 50, 51, 52, 53, and pumps 41,42. Claim 2 recites the reducing agent is configured to react with a detection dye in the presence of the analyze to initiate a color change. Claim 2 is considered an intended use since the reducing agent is not considered part of the device. Regardless, Battrell teaches a reducing agent configured to react with a detection dye in the presence of the analyte to initiate a color change (means for detection of particles, beads and microspheres may include "labels" or "tags" such as, but not limited to, dyes such as chromophores and fluorophores; FRET probes (including those known as "Molecular Beacons"), enzyme-linked antibodies and their chromogenic substrates, radio frequency tags, plasmon resonance, or magnetic moment as are known in the prior art. Claims 3 and 14 are directed to the reducing agent. For example, claim 3 recites the reducing agent is configured to generate a gas in the reagent well when the analyte is present in the fluid sample. This considered an intended use and conditional given the optional “when clause”. Battrell teaches the reducing agent is configured to generate a gas in the reagent well when the analyte is present in the fluid sample, the gas generated in the reagent well configured to propel the fluid sample from the reagent well into the test well. Also shown are right and left valves 46, 47 controlling microfluidic channels 48, 49 ,52, and 53 used in sample and reagent addition, mixing, rinsing, and in venting air (including any gases produced) during sample loading. Regarding claim 4, Battrell teaches valve assembly comprises a one-way valve configured to allow the fluid sample and the gas generated in the reagent well to move from the reagent well towards the test well, and to prevent the fluid sample and the gas generated in the reagent well from moving upstream of the one-way valve (specifically, Battrell teaches one-way "check" valves can be used and art and can be used to direct the flow of solubilized reagents and sample for microfluidic device-based assays). Claims 5, 6 and 8 are directed to a detection dye. The dye is not considered part of the device itself and has not received patentable weight. Battrell does teach dyes beginning at page 21, last full paragraph from the top. Regarding claim 7, Battrell teaches the fluid flow path comprises a mixing feature downstream of the sample reservoir (inside the test well), the mixing feature comprising a plurality of posts (shown but without a reference number in Fig. 17B) disposed in the fluid flow path , the plurality of posts configured to promote mixing of the fluid sample with the detection dye when the fluid sample is added to the sample reservoir. As shown in Fig. 17B, Battrell teaches different configurations and the effect on fluid advancing through the sealed reaction chamber. Surface modification, geometry, and surface features are useful to control wetting and would inherently provide mixing as the fluid flows between the posts as shown in Fig. 17B. Claims 9 and 10 are directed to the analyte. The analyte is not considered part of the device and therefore has not received patentable weight for the reasons delineated above. Regarding claim 15, Battrell teaches a gas vent 59 downstream of the test well 43, wherein the gas vent is configured to allow gas in the fluid flow path to evacuate the device after the fluid sample is added to the sample reservoir and begins to flow in the fluid flow path (see Fig. 3). Regarding claim 16, Battrell teaches the gas vent comprises a frit 101,106 configured to seal to the passage of gas and the fluid sample in the presence of the fluid sample (see Fig. 8A). Regarding claim 17, Battrell teaches a top substrate (first surface) comprising portions of the fluid flow path and a bottom substrate comprising portions of the fluid flow path, and wherein the fluid flow path further comprises a plurality of junction points formed by a gasket 203 when the top substrate is coupled to the bottom substrate, wherein the plurality of junction points are configured to move the fluid sample between the top substrate and the bottom substrate as the fluid flows from the sample reservoir to the test well (Battrell teaches in Figs. 13A-24, the inventive apparatus 200 is formed on a baseplate 201, which may be built up from layers to enclose fluidic circuits or may be injection molded in one or more pieces. A glass slide 202, with specimen(s) mounted thereon, is affixed to the baseplate using an edge gasket 203 as will be shown in FIGS. 13B and 13C in more detail. The specimens 204 in this illustration are on the underside of the glass surface. A compliant internal gasket 311 forms a seal around the sealed reaction chamber 310 when the slide is click locked in place. Other means for sealing and clamping, for example as described in FIGS 21 and 22, may also be used (see page 41 beginning at first full paragraph et seq.) Regarding claim 18, Battrell teaches a housing 201 comprising a viewing window 205 positioned above a top surface of the test well and a top surface of the control well, wherein optical signals read through the viewing window from the test well are different than optical signals read through the viewing window from the control well when the analyte is present in the fluid sample. Specifically, Battrell teaches the inventive apparatus 200 is formed on a baseplate 201, which may be built up from layers to enclose fluidic circuits or may be injection molded in one or more pieces. The specimens 204 in this illustration are on the underside of the glass surface. An aperture on the top web of the edge gasket defines an observation window 205 with viewing area 206 through the upper surface of the glass slide, as may be useful for photography or microscopy. A recess under the glass slide forms the sealed reaction chamber 207 (see page 41 beginning at first full paragraph et seq.) Claim Rejections - 35 USC § 103 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 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. Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Battrell in view of Nelson et al., (US 2020/0391214; hereinafter “Nelson”). Regarding claim 11, Battrell discloses sample reservoir 5. However, Battrell does not specifically disclose the sample reservoir comprising an overflow reservoir arranged concentrically around the sample reservoir. In the related art of reaction devices, Nelson teaches a sample reservoir 130 comprising an overflow reservoir 150 arranged concentrically around the sample reservoir (see para [0034] et seq. and Figs. 1-3) Nelson teaches that this configuration of the sample reservoir provides a reaction device 100 configured to self-meter amounts of sample provided in the detection device. Dimensions of metering reservoir 130, sample reservoir 140, overflow chamber 150, and plunger 160 may be selected so that device 100 is configured to dispense a specific or desired amount of self-metered fluid. Nelson teaches this allows a user to dispense the initial amount of fluid 210 into sample reservoir 140 by eyeing the amount being dispensed in or by using a simple dispenser, for example, an eyedropper. Once fluid 210 has been dispensed in sample reservoir 140, the user may close cartridge 110 by folding over plunger 160 and inserting plunger 160 into overflow chamber 150, further into sample reservoir 140, and then further into metering reservoir 130. When plunger 160, and more specifically flare 166, engages opening 134 of metering reservoir 130, as illustrated in FIG. 3, a seal may be formed so that sealed fluid 310 contained in metering reservoir 130 cannot flow into the remaining portion of sample reservoir 140. Conversely, unsealed fluid 320 in the remaining portion of sample reservoir 140 cannot flow into metering reservoir 130 once the seal is formed. The user may continue to insert 160 into metering reservoir 130 past the point where the seal is formed so that sealed fluid 310 is plunged through opening 132 of metering reservoir 130 into reaction chamber 120, as illustrated in FIG. 4 (see para [0033] et seq.) Nelson recognizes that this self-metering sample reservoir delivers the correct amount of needed fluid to the device to an enable ease and flexibility of use, robustness, and/or precision. With a self-metering system, an untrained person does not have to utilize specialized equipment to meter out the correct amount of fluid. Such system can then be used irrespective of whether a technical facility is available and therefore the reactions can be performed in a wider range of settings. Furthermore, the risk of user error can be reduced (see para [0010] et seq.) Accordingly, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to include or substitute the sample reservoir in Battrell with the particular sample reservoir and cap of Nelson, since the combined detector device would provide a consistent and self- metered amount of sample to the reaction wells with ease, flexibility of use, robustness, and/or precision. With a self-metering system of Nelson, an untrained person does not have to utilize specialized equipment to meter out the correct amount of fluid (see para [0010] et seq.) Regarding claim 12, Nelson teaches a cap comprising an outer seal 164 and an activation plunger 160 comprising an inner seal attached to the cap (see para [0030] et seq. and Figs. 1A-3). Claim 13 is directed to functional/process language and has not received patentable weight for the reasons delineated above. Nevertheless, Nelson teaches the activation plunger is configured to sealably couple with the sample reservoir 115, and configured to propel a pre-determined volume of fluid sample through the fluid flow path (see para [0030] et seq.) Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Battrell in view of Benter et al., (US 2021/0063291; hereinafter “Benter”). Regarding claim 23, Battrell teaches a heating element comprising a printed circuit board and an external power connector, the printed circuit board comprising a plurality of heaters positioned below the reagent well, the test well, and the control well. Battrell teaches a housing 208, 2011 contains heating or cooling elements and an electrical junction is required for mounting a wire harness to one end of the slide. The resulting electrical connection(s) may be useful for powering an electrode array in the reaction chamber or for operating a thermistor, while not limited thereto. Battrell teaches a heating device or Peltier chips may be placed in the raised platform and used control the temperature within the reaction chamber. While Battrell teaches general heating element and Peltier chip, Battrell does not specifically teach the use of resistive heating elements. In the related art of detection devices for detecting an analyte in a fluid sample, Benter recognizes the structural equivalence of using Peltier elements or a heating resistor elements for providing the expected thermal effect on the reaction chamber (Benter-see para [0117] et seq.) It would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to determine the optimum type of heating element necessary to heat the reaction chamber based on considerations such as cost, ease of manufacture, reactions with the processing agents and/or maintaining the required reaction conditions with respect to temperature. In addition, the Supreme Court has clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, "[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp." An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int'l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143). In this case, both Peltier and resistive type heaters are known in the analyte detection device art to be interchangeable and yield the same predictable result of providing thermal effect to reaction chambers in a controlled and effective manner. Allowable Subject Matter Claims 19-22 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. Although each limitation may be individually known in the art in isolation, there appears to be no prior art reference which discloses how or why one would modify the device of claims 1 and 18 to include a heating element substrate comprising a heat activation reservoir, wherein a top surface of the heat activation reservoir is generally coplanar with the top surface of the test well and the top surface of the control well, the housing further comprising an access window positioned above the top surface of the heat activation reservoir, wherein the heat activation reservoir configured to receive an activation agent through the access window, to arrive at the combination set forth in the claim 19. The examiner considers Battrell the closest prior art to the claimed invention (see the rejections set forth above), but Battrell does not disclose the limitations of claims 19-22. Citations to art In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well. Conclusion No claims are allowed. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure i. Weidemaier et al., (US 2021/0378567) which teach a blood separation device that allows high quality plasma to be generated using a single power source. The device includes a housing with an inlet port adapted to receive the blood sample, a first chamber having a first chamber flow channel in fluid communication with the inlet port, a second chamber having a second chamber flow channel, a separation member disposed between the first chamber and the second chamber. In some embodiments, the blood separation device detects or tests for the presence of a substance, such as an antigen or an antibody. ii. Handique et al., (US 2007/0184547) which teach a microfluidic system for converting a sample containing one or more polynucleotides into a form suitable for analyzing the polynucleotides, comprising: a cartridge receiving element, an insertable and removable cartridge, a heating element configured to heat one or more regions of the cartridge, and control circuitry, wherein the insertable cartridge comprises: a microfluidic component that is configured to accept the sample and one or more reagents, and to react the sample and the reagents, in order to produce a prepared sample suitable for analyzing the one or more polynucleotides. The invention further comprises a multi-sample cartridge for converting a number of samples, each containing one or more polynucleotides, into respective forms suitable for analyzing the polynucleotides, comprising: at least a first microfluidic component and a second microfluidic component. Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached between 9:30am-7pm EST. Examiner interviews are available via telephone 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. E-mail communication Authorization Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300): Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file. Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on 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. /P. Kathryn Wright/Primary Examiner, Art Unit 1798
Read full office action

Prosecution Timeline

Feb 22, 2023
Application Filed
Mar 04, 2026
Non-Final Rejection — §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
66%
Grant Probability
99%
With Interview (+42.4%)
3y 6m
Median Time to Grant
Low
PTA Risk
Based on 912 resolved cases by this examiner. Grant probability derived from career allow rate.

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