Prosecution Insights
Last updated: October 04, 2026
Application No. 18/301,835

FLUIDIC MEDICAL DEVICES AND USES THEREOF

Non-Final OA §102§112§DP
Filed
Apr 17, 2023
Priority
May 09, 2005 — provisional 60/678,801 +7 more
Examiner
GORDON, BRIAN R
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Golden Diagnostics Corp.
OA Round
3 (Non-Final)
65%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
84%
With Interview

Examiner Intelligence

Grants 65% — above average
65%
Career Allowance Rate
632 granted / 970 resolved
At TC average
Strong +19% interview lift
Without
With
+18.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
40 currently pending
Career history
1015
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
28.2%
-11.8% vs TC avg
§102
24.4%
-15.6% vs TC avg
§112
38.6%
-1.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 970 resolved cases

Office Action

§102 §112 §DP
DETAILED ACTION The present application is being examined under the pre-AIA first to invent provisions. Continued Examination Under 37 CFR 1.114 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 8, 2026 has been entered. Election/Restrictions Applicant’s election without traverse of Group I, claims 1-16 in the reply filed on December 12, 2024 is acknowledged. Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Response to Arguments Applicant's arguments filed April 8, 2026 have been fully considered but they are not persuasive. It is noted that applicant has amended claim 1, but fails to specify where such amendments are described within the originally filed specification. It is hereby requested that applicant provide for the specific text of the specification that supports each and all amendments. It is noted that applicant has amended the preamble of claim 1 to now be directed to “A system”, but fails to further amend the claims to be consistent with such. See rejections herein. Claim 1 prior to the amendment was directed to an apparatus (the fluidic device 2) defined by a)-c). Now the amendment appears to be directed to a system defined by the fluidic device 2 defined by a) -c) and the reader assembly as shown in Figure 1. However, there is no mention of the fluidic device being defined by a)-c) in claim 1. Applicant’s arguments are essentially the same as those previously addressed in the Final Office Action (10/08/25). As to the 112 rejections, applicant assert that the claims are not indefinite and all follow antecedent basis conventions and are clear on their face. There is no reasonable interpretation that renders these features indefinite. The examiner disagrees. Applicant has not amended the claims to address each of the issues/claims and does not specify what is the proper antecedent basis for each of the terms recited in the rejections. For example, in 1b) the claim recites “a plurality of reactant chambers carrying a plurality of reactants” and “said plurality of reaction sites comprise a plurality of reactants”. Therefore, it is unclear which/what plurality of reactants is being referenced by the later recited phrase “said plurality of reactants”. The plurality of reaction sites are not listed, positively claimed as elements of the apparatus (system). In 1a), it presumed that “in fluid communication with a plurality of reaction sites” refers to the sample collection unit. However, reciting that a positively claimed element is in fluid communication with structures not previously claimed (a plurality of reactions sites) does not require the plurality of reaction sites to be structural elements of the apparatus. The plurality of reaction sites do not further structurally limit the apparatus. If applicant intends for the invention to comprise a plurality of reaction sites, then the claim should clearly recite such. It is unclear what/which reaction sites are being referenced by “said reaction sites” in 1b) and 2. It such is intended to refer to the plurality of reaction sites, then the claims should clearly recite “said plurality of reaction sites”. See rejection herein. Applicant has not indicated what the pronoun “thereto” references. To resolve such issue and for clarity, the claim can be amended to replace “thereto” with what the term specifically references. If “the fluid” in claim 6 is meant to refer to “the biological fluid”, the claim should be amended to recite such (same as recited in claim 4). However, the biological fluid (and amount of the biological fluid) is not a structural element of the apparatus and does not further structurally limit the claimed apparatus. The 112 rejections are proper and maintained for reasons previously stated in the prior Office Actions and herein. Rejections not repeated herein have been withdrawn. As to the art rejections based upon Glezer and Parce, applicant states: “Neither Glezer nor Parce disclose or suggest at least that "at least one channel located between said plurality of reaction sites comprises an optical barrier to reduce the amount of optical cross-talk between said plurality of said reaction sites during detection of said analyte," as recited in claim 1. And the Office does not adequately address such features in its rejection. Indeed, Glezer specifies different procedures for handling cross-talk - using blocking reagents or minimizing diffusion of an unbound assay reagent (Glezer, 3:16-30, 36:36 42). And Parce does not address optical cross-talk at all.” The examiner disagrees. The claims are directed to an apparatus not any procedure/method that requires any reduction of any cross-talk. However, there is no indication, relative basis provided for in the claim as to what is considered as a reduction in cross-talk. According to claim 1 an “optical barrier” is at least one channel and according to claim 5 an optical barrier is a nonlinear fluidic channel. The apparatus of Glezer comprises fluidic channels including nonlinear fluidic channels as stated in the rejections. Furthermore, Glezer discloses a reader assembly comprising a controller and an identifier detector. The external device, protocol, and instructions are not structural elements of the invention. See remarks and rejections herein. Therefore, the claims are rejected as given herein. 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. Priority The Cross-Reference paragraph should be updated to reflect the current status of all related applications, including those not currently mentioned in the passage. Claim Interpretations 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 claimed apparatus is stated as being for detecting an analyte in a biological fluid. However, no biological fluid (unspecified) is claimed as an element of the device. The claims also mention a plurality of analytes, a list of what the immunoassay reagents can detect, and a detectable signal. Claim 1 mentions also a plurality of reaction sites, identifier (not structurally specified), information (not structure and not specified), protocol (not specified, defined in the claims), external device (not structurally defined in the claim), instructions (not structure and not specified) of the external device, and detection method (not structure nor defined by any specific steps). However, none of the prior are structural elements of the claimed invention, but are materials and/or articles intended be/can be worked upon and/or used with the claimed apparatus. The plurality of reaction sites are not listed as elements of the invention nor claimed as being any positively claimed elements. The “configured to…” clauses of 1d) are directed to intended, possible use of the identifier detector and reader assembly relative to further unclaimed structures and/or materials. In 1a) it presumed that “in fluid communication with a plurality of reaction sites” refers to the sample collection unit is in fluid communication with a plurality of reaction sites. However, reciting that a positively claimed element is in fluid communication with structures not previously claimed (a plurality of reactions sites) does not require the plurality of reaction sites to be structural elements of the apparatus (system). If applicant intends for the invention to comprise a plurality of reaction sited, then the claim should clearly recite such. Furthermore, the "for detecting" and “during detection” phrases are directed to intended use of the device. Therefore claims 8-11 are directed to the intended use/process steps of the claimed apparatus. However, it is noted that the apparatus is not required to be used to perform any method, process steps, including detecting and any other process steps. The various “to allow…”, “to flow…” and “to reduce…” phrases are directed to intended use. It is noted that the term “plurality” only requires 2. As to claim 1, it is noted that the claims do not specify the distribution of the reactants within the plurality of chambers/sites. Therefore, the claims do not require that each of the plurality of chambers/sites to include a plurality of reactants. Furthermore, it is noted that the claims are directed to an apparatus not a process of use. It is not required that the apparatus to be used for any detection of analytes. However, it is noted that there is no requirement for any detecting to be performed. As to claim 1, it is noted that the phrase “at least one channel” does not preclude more than one channel from being located between two reaction sites (not claimed as structural elements of the invention). It is noted that the phrases “located between” does not provide for, require any structural connectivity of any structures. It is noted that phrase “to reduce optical cross-talk” is directed to an intended purpose of the optical barrier (at least one channel). However, there is no requirement for anything related to any optics (including any unspecified reactions of anything) to be performed such that any optical cross-talk is able to occur between the plurality of reaction sites that have not been positively claimed/listed as elements of the invention. It does not appear that the at least one channel comprises an optical barrier, but the at one channel is (can function as) an optical barrier as recited in claim 5. As to the phrase "waste chambers" in claim 2, it is noted that the claims do not provide for any structural distinction between waste chambers and reactant chambers. It appears that the term “waste” is directed to the intended use of the chamber rather than any specific structural requirement of the chamber. There is no requirement for any unspecified “waste” to be present in any chambers. It is noted that claim 3 recites “each channel”, however it is not required that the device comprise more than one such channel, for a device comprising 2 sites would only require 1 channel therebetween. Furthermore, claims 4 and 6 are not further structurally limiting because the claims are directed to an unclaimed biological fluid and fluid (presuming the phrase, "the fluid" in claim 6 refers to the biological fluid). The biological fluid is not a structural element of the invention (not required be present). Therefore, biological fluid that can be used with the system does not structurally define the system. There is no requirement for any owner, user, possessor, etc. of the system to use the system for anything, including with any biological fluid as may be intended by applicant. 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 1-11 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 pre-AIA the applicant regards as the invention. As to claims 1-2, it is unclear which plurality of reactants are being referenced by the phrases "said plurality of reactants" and what/which reaction sites are being reference by the phrase, “said reaction sites”. As to claim 1, it is unclear what the pronoun, “thereto” references. As to claims 1 and 3, it is unclear what further structure the at least one channel and each channel respectively comprise that applicant is referring to as an optical barrier. It appears that the channel itself doesn't comprise an optical barrier, but actually can function as an optical barrier (as recited in claim 5). Therefore, the claims should clearly recite such. As to claim 1, in c) it is unclear what is the structural nexus of the “at least one channel” to the prior “system of fluidic channels” because the claim does provide for such. It is unclear if the at least one channel is amongst the system of fluidic channels or different from such fluidic channels because the claim does not clearly recite such. Furthermore, it is unclear how the invention can be defined as requiring at least one channel to be located between said plurality of reaction sites because the plurality of reaction sites are not positively claimed as structural elements of the invention. This is also applicable to claims 2-3. Claim 1 recites the limitation "said apparatus" in paragraph c). There is insufficient antecedent basis for this limitation in the claim. No apparatus has been previously claimed as an element of the invention. Although no flowing of any biological fluid is required to be performed, it is unclear what apparatus is being referenced by “said apparatus” in the paragraph (see also “said apparatus” in claim 8). The preamble of the claim as been amended to “A system”…. The claim is applicable to claims 2-11 which recite “The apparatus”. It is unclear what apparatus is being referenced if such is the same or different from “said apparatus”. If the claims are intended to be directed to “The system…”, then the claims should be amended to indicate such. As to claim 1, it is unclear what structure disclosed in the specification and show in the drawings is the optical barrier of a channel. The examiner fails to locate such. It appears that the channel does not comprise any such optical barrier, but the non-linear channel itself is the optical barrier. As to claim 1, paragraph d), although no detecting of any unclaimed, structurally undefined “identifier” of any unspecified, unclaimed analyte is ever required to be performed, it is unclear what is required of such “identifier” to be considered as “corresponding” to the analyte because the claim does not provide for such. Claim 1 recites the limitation "the information" in paragraph d). There is insufficient antecedent basis for this limitation in the claim. Although information is not structure, there is no prior mention of any unspecified information. Furthermore, there is no requirement for the reader assembly (only defined in the claim as a detector identifier) to receive any unspecified information to ever be received from any unclaimed identifier. Therefore, it is unclear what is structurally required by the phrase “and in response to the information based on the identifier…”. Although no external device (not structurally defined in the claim) is positively claimed as an element of the invention, it is unclear what such “external device” is required to be external relative to because the claim does not provide for such. Any device can be considered as being “external” to some other structure that is not an element of the device. Furthermore, a protocol is not structure and not claimed as an element of the invention, it is noted that the “protocol” (presumptively a method) is not defined in the claim. Furthermore, it is unclear what includes instructions (not structure, not positively claimed, nor specified in the claim)...the protocol or the external device. It is unclear what is the nexus of the unspecified instructions to the unspecified protocol because the claim does not provide for such. Furthermore, although a detection method is not structure, it is unclear what includes the detection method (the protocol, instructions, controller?) and how any structure can include “a detection method” because the claim does not clearly provide for such. A detection method is defined by a list of steps. Although no detection method is ever required to be performed, it is unclear what steps (what is done) to define the detection method because the claim does not provide for such. The language employed in the paragraph is confusing. It appears as if the paragraph should begin as: “d) a reader assembly comprising a controller….and an identifier detector….” Claims 2-11 are rejected via dependency upon a rejected claim. As to claim 3, it is unclear what/which channel(s) is/are being referenced by the phrase “each channel…” because claim 1 previously recites a system of fluidic channels and at least one channel. It is unclear how claims 4 and 6, further structurally limit the claimed apparatus (system) for the biological fluid nor any other fluid has been positively claimed as elements of the invention. The claims are directed to unclaimed fluids. The fluids are not required to be present as elements of the apparatus and do not further structurally define the apparatus. Claim 6 recites the limitation "the fluid" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear which/what fluid is being referenced by the phrase "the fluid". No fluid has been previously claimed as an element of the apparatus. As to claim 5, it is unclear how now the optical barrier comprises a nonlinear fluidic channel, when previously claim 1 states, at least one channel comprises an optical barrier. Clam 5 contradicts claim 1. The most accurate description appears to be than the device comprises non-linear channels located between….that can function as optical barriers. As to claim 7, and 9-10, it is unclear what reactants are being referenced by the phrase “the reactants” because claim 1 previously mentions a plurality of reactants at two different locations (plurality of reactant chambers and unclaimed plurality of reaction sites) and it has not been previously established if the plurality of reactants at both locations are the same or different. Therefore, it is unclear what/which reactants are being referenced by “the reactants”. It is unclear what is structurally required, meant by claims 8-11 because the claims do not provide for any additional structural element nor provide for any further structure of a previously positively claimed element. The claims are directed process steps of what the invention can be employed to do relative to unclaimed plurality of analytes, what the immune assay reagents can be used to detect, and signals that are not structures. It is unclear how claim 8, further structurally limits the claimed apparatus for the plurality of analytes have not been positively claimed as elements of the invention. Furthermore, it is unclear what "distinct signals" are being referenced. Signals are not elements of the apparatus. Furthermore, it is unclear what is being referenced by the phrase "range of 3 orders of magnitude". Range of what? Relative to what? Who or what determines such magnitude or any other determination. The apparatus has not been claimed as comprising a detector or any other structure for making and measurement of any type of signals. It appears moreso as if applicant is referring to how the device can be used with some unspecified analytes and detector. It is unclear how the reagents of claim 9-10 "detect". The reagents do not detect anything. It appears that applicant may be referring to ability of the reagents to react with specific substances and such reactions can be detected by a detector/reader. Claim 11 recites the limitation "the detectable signal" in line 1. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is noted that “a signal” a used in this application is not a physical structure and cannot be claimed as an element of the apparatus presently drafted. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of pre-AIA 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 – (e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language. Claims 1-11 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Glezer et al, US 7,497,997. Glezer et al. disclose assay modules, preferably assay cartridges, are described as are reader apparatuses which may be used to control aspects of module operation. The modules preferably comprise a detection chamber with integrated electrodes that may be used for carrying out electrode induced luminescence measurements. Methods are described for immobilizing assay reagents in a controlled fashion on these electrodes and other surfaces. Assay modules and cartridges are also described as having a detection chamber, preferably having integrated electrodes, and other fluidic components which may include sample chambers, waste chambers, conduits, vents, bubble traps, reagent chambers, dry reagent pill zones and the like. (abstract). The invention relates in part to assay cartridges. An assay cartridge of the invention incorporates one or more fluidic components such as compartments, wells, chambers, fluidic conduits, fluid ports/vents, valves, and the like and/or one or more detection components such as electrodes, electrode contacts, sensors (e.g., electrochemical sensors, fluid sensors, mass sensors, optical sensors, capacitive sensors, impedance sensors, optical waveguides, etc.), detection windows (e.g., windows configured to allow optical measurements on samples in the cartridge such as measurements of absorbance, light scattering, light refraction, light reflection, fluorescence, phosphorescence, chemiluminescence, electrochemiluminescence, etc), and the like. A cartridge may also comprise reagents for carrying out an assay such as binding reagents, detectable labels, sample processing reagents, wash solutions, buffers, etc. The reagents may be present in liquid form, solid form and/or immobilized on the surface of solid phase supports present in the cartridge. (column 37, lines 31-48). The cartridge as seen in Figure 14A comprises a sample chamber 1420 (sample collection unit); detection chambers 1445/1446 (reactant chambers) including bound reagents (plurality of reaction sites) in fluid communication with reagent chambers 1425/1426 via a plurality of nonlinear fluidic channels 1140/1441 (system of fluidic channels), and waste chambers1430/1431. (column 57, line 8 - column 58 line 50). The detection chamber is designed to accommodate sample volumes between 0.1-1000 uL, more preferably, 1-200 uL, more preferably, 2-50 uL, most preferably, 5-25 uL. In embodiments that are limited by sample volume (e.g., cartridges measuring blood from finger pricks), especially preferred detection chamber volumes are less than 10 uL, more preferably 0.5-10 uL, even more preferably 2-6 uL. (column 49, lines 44-51). The apparatus comprises a barcode reader 2365 (an identifier detector) is incorporated on/within the cartridge reader (reader assembly) to preferably automatically scan an identifying mark/label 2370 (identifier) on the cartridge; e.g., as it is drawn into the reader. The label may contain encoded information (of the identifier) relating to the specific assays that are to be performed, calibration parameters and/or any other information required to perform the assay. (column 53, lines 5-11). The reader may have a microprocessor (controller) for controlling the mechanical and/or electronic subsystems, analyzing the acquired data and/or providing a graphical user interface (GUI). (column 15, lines 60-67). As to claims, 7-11, the immunoassay reagents are used to detect a number of various specific substances within biological samples including via luminescence. (column 75, line 38 – column 77, line 9; abstract). 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 1, 3, and 7-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 and 8 of U.S. Patent No. 9,772,291. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the Patent provide for each of the structural elements or equivalents of the elements of the instant application such scope of the instant claims are encompassed within the claims of the Patent. The claims of the Patent are: 2. A system for detecting an analyte in a biological fluid of a subject, comprising a) a cartridge comprising: a plurality of reaction sites; a sample collection unit for introducing a biological fluid in fluid communication with the plurality of reaction sites, wherein each of said plurality of reaction sites comprise one or more reactants bound thereto for detecting said analyte; a plurality of reactant chambers comprising a plurality of reactants in fluid communication with said plurality of reaction sites, a system of fluidic channels to allow said biological fluid and said plurality of reactants to flow in said cartridge; an identifier on said cartridge; a wall of at least one of said plurality of reaction sites comprises an optically opaque material so that light will not escape said at least one of said plurality of reaction sites through said wall; wherein said at least one of said plurality of reaction sites comprises a reaction surface with bound reactants around a center of the at least one of said plurality of reaction sites and said bound reactants are spaced apart from a wall of the at least one of said plurality of reaction sites by a concentric ring-shaped area, said at least one of said plurality of reaction sites configured to reduce signal from any unbound conjugates remaining in the at least one of said plurality of reaction sites; and b) a reader assembly for receiving the cartridge and comprising: a controller; and an identifier detector to detect the identifier on the cartridge. 8. A system for detecting an analyte in a biological fluid of a subject, comprising a) a cartridge comprising: a plurality of reaction sites; a sample collection unit for introducing a biological fluid in fluid communication with the plurality of reaction sites, wherein each of said plurality of reaction sites comprise one or more reactants bound thereto for detecting said analyte; a plurality of reactant chambers comprising a plurality of reactants in fluid communication with said plurality of reaction sites, a system of fluidic channels to allow said biological fluid and said plurality of reactants to flow in said cartridge; an identifier on said cartridge; a wall of at least one of said plurality of reaction sites comprises an optically opaque material so that light will not escape said at least one of said plurality of reaction sites through said wall; wherein said at least one of said plurality of reaction sites comprises a reaction surface with bound reactants around a center of the at least one of said plurality of reaction sites and said bound reactants are spaced apart from a wall of the at least one of said plurality of reaction sites by a concentric ring-shaped area, said at least one of said plurality of reaction sites configured to reduce signal from any unbound conjugates remaining in the at least one of said plurality of reaction sites; and b) a reader assembly for receiving the cartridge and comprising: a controller; an identifier detector to detect the identifier on the cartridge; and a communication assembly, wherein said identifier detector communicates with the communication assembly that is controlled by said controller. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Glezer, Eli N. et al.; Ewart; Thomas et al.; and Wohlstadter; Jacob et al. disclose detection devices and methods of use. 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

Apr 17, 2023
Application Filed
Jan 07, 2025
Non-Final Rejection mailed — §102, §112, §DP
Jul 07, 2025
Response Filed
Oct 08, 2025
Final Rejection mailed — §102, §112, §DP
Apr 08, 2026
Request for Continued Examination
Apr 10, 2026
Response after Non-Final Action
Apr 10, 2026
Response after Non-Final Action
Sep 17, 2026
Non-Final Rejection mailed — §102, §112, §DP (current)

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Prosecution Projections

3-4
Expected OA Rounds
65%
Grant Probability
84%
With Interview (+18.9%)
3y 2m (~0m remaining)
Median Time to Grant
High
PTA Risk
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