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 .
Response to Amendment
The amendments and remarks, filed on 11/11/2025, has been entered. The claim amendments overcome the previous claim objections of claims 3-6 and 8-14 and 112(b) rejection of claims 1, 6, 8, 9, 11, 12, and 14.
The amendments and remarks, filed on 11/11/2025, has been entered. The claim amendments overcome the 101 rejection of claim 14.
The amendments and remarks, filed on 11/11/2025, has been entered. The claim amendments overcome the previous prior art rejection, and a new prior art rejection is applied to address the claim amendments.
Election/Restrictions
Newly amended claim 14 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1, 3-6, and 8-13, drawn to a portable device.
Group II, claim(s) 14, drawn to a method of using the device. Applicant has amended the claim, thus the claims have a different preamble than originally presented and appear to only require a portion of claim 1 which is improper.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Group I and II lack unity of invention because even though the inventions of these groups require the technical feature of a portable device for detecting and quantifying a concentration of a marker, for example TROPONIN I, present in a sample of biological fluid, said device comprising:
- a cartridge adapted to receive said biological fluid sample and comprising at least one reactive agent configured to bind to the marker defining an electrochemiluminescent solution; said cartridge comprising an electrode cell configured to supply electrical energy to the electrochemiluminescent solution so as to trigger an electrochemiluminescence reaction of said electrochemiluminescent solution, generating a light signal representative of a concentration value of said marker in said biological fluid sample; - an analyzer, connected or connectable to said cartridge and configured to receive said light signal and analyze at least one property of said light signal so as to quantify a concentration of said marker in the biological fluid; wherein said cartridge comprises:- a chamber for receiving said biological fluid sample, preferably with a conical or frustoconical shape, adapted to collect said biological fluid sample;- a first reaction chamber, arranged in fluid communication with said receiving chamber and comprising a first reactive agent configured to bind to said marker of said biological fluid sample;- a second reaction chamber, arranged in fluid communication with said first reaction chamber, said reaction chamber being interposed between the receiving chamber and the second reaction chamber, and comprising a second reactive agent configured to bind to said marker of said biological fluid sample; said second reaction chamber comprising a covering element transparent to the electromagnetic radiation generated by said electrochemiluminescence reaction to allow the reception of the electromagnetic radiation by the analyzer; characterized by the fact that said cartridge comprises a washing chamber, arranged in fluid communication with said second reaction chamber and comprising an absorption element configured to absorb and remove from said second reaction chamber an excess portion of said electrochemiluminescent solution; said excess portion of said electrochemiluminescent solution being a portion of said excess biological fluid sample and/or a portion of said first reactive agent not bound to said marker and/or a portion of said second reactive agent not bound to said marker, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Glezer et al (US 20040189311 A1; hereinafter “Glezer”; already of record). Glezer teaches a portable device (Glezer; para [227]; cartridge 900) for detecting and quantifying a concentration of a marker, for example TROPONIN I, present in a sample of biological fluid (Glezer; para [296]; The assay modules (preferably, assay cartridges) may be used to carry out panels of assays. Suitable panels include panels of assays for analytes or activities associated…cardiac markers, e.g., one or more of Troponin T, Troponin I), said device comprising: - a cartridge adapted to receive said biological fluid sample (Glezer; para [227]; a sample chamber 920) and comprising at least one reactive agent configured to bind to the marker defining an electrochemiluminescent solution (Glezer; para [297]; The one or more assay reagents may include, but are not limited to, binding reagents, preferably, labeled binding reagents, more preferably binding reagents labeled with electrochemiluminescent labels); said cartridge comprising an electrode cell configured to supply electrical energy to the electrochemiluminescent solution so as to trigger an electrochemiluminescence reaction of said electrochemiluminescent solution, generating a light signal representative of a concentration value of said marker in said biological fluid sample (Glezer; para [6]; the steps of applying electrical energy between first and second electrodes, measuring an assay dependent signal at the second electrode, applying electrical energy between the second electrode and a third electrode and measuring an assay dependent signal at the third electrode. The measured assay dependent signal is, preferably, selected from electrical current, electrical potential and/or electrode-induced luminescence); - an analyzer (Glezer; para [100, 252]; a cartridge-based biochemical detection system 100), connected or connectable to said cartridge (Glezer; para [100, 252]; system housing, e.g., cartridge reader 105, would include an optical detector 110 and would be adapted and configured to receive and position cartridge 115) and configured to receive said light signal and analyze at least one property of said light signal so as to quantify a concentration of said marker in the biological fluid (Glezer; para [12]; the apparatus can be configured with an optical detector for detecting luminescence generated at the dedicated working and dual-role electrodes); wherein said cartridge comprises: - a chamber for receiving said biological fluid sample, preferably with a conical or frustoconical shape (Glezer; para [187]; the sample chamber has an elongated shape with the two conduits being arranged to intersect at or near the opposing ends of the length; examiner notes the chamber would be frustoconical because the elongated shape of the chamber would have different size for the conduit and the sample inlet. The inlet is sized to receive an applicator, para [33], and the conduit allows capillary flow, para [152]), adapted to collect said biological fluid sample (Glezer; para [34]; sample chamber having sample introduction port with a sealable closure wherein the sample chamber is adapted to receive an applicator stick); - a first reaction chamber, arranged in fluid communication with said receiving chamber and comprising a first reactive agent configured to bind to said marker of said biological fluid sample (Glezer; para [25]; detection chamber, preferably, a detection chamber having one or more binding domains having immobilized binding reagents connected to the sample and waste chambers via sample); - a second reaction chamber, arranged in fluid communication with said first reaction chamber, said reaction chamber being interposed between the receiving chamber and the second reaction chamber, and comprising a second reactive agent configured to bind to said marker of said biological fluid sample (Glezer; para [29]; a second reagent chamber holding a second liquid reagent); said second reaction chamber comprising a covering element transparent to the electromagnetic radiation generated by said electrochemiluminescence reaction to allow the reception of the electromagnetic radiation by the analyzer (Glezer; para [31]; at least a portion of one wall of the detection chamber may be substantially transparent to allow optical monitoring of materials in the detection chamber);
characterized by the fact that said cartridge comprises a washing chamber, arranged in fluid communication with said second reaction chamber (Glezer; para [35]; the waste chamber may be connected to the detection chamber via a waste conduit and the wash reagent chamber connected to the sample conduit via a wash conduit) and comprising an absorption element configured to absorb and remove from said second reaction chamber an excess portion of said electrochemiluminescent solution (Glezer; para [206]; the waste chambers contain a water absorbing material, such as a sponge); said excess portion of said electrochemiluminescent solution being a portion of said excess biological fluid sample and/or a portion of said first reactive agent not bound to said marker and/or a portion of said second reactive agent not bound to said marker (Glezer; para [205]; The waste chambers are chambers adapted to hold excess or waste liquid); preferably said absorption element being made of hydrophilic material, even more preferably said absorption element being made of cellulose diacetate (see 112(b) rejection above).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 14 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Status
Claims 1, 3-6, and 8-14 are pending with claims 1, 3-6, and 8-13 being examined and claim 14 is withdrawn.
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, 3-6, and 8-13 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 1 recites the limitation “a chamber for receiving said biological fluid sample, with a conical or frustoconical shape, adapted to collect said biological fluid sample” in lines 15-16. The limitation is unclear as to whether the shape of the chamber is required in order to be “adapted to collect said biological sample”. Specifically, is the chamber not capable of collecting said biological fluid sample without the conical or frustoconical shape? Further, the limitation already recites “a chamber for receiving said biological fluid sample”, thus the following limitation is repetitive. Does applicant intend for an additional biological sample to be introduced? Claims 3-6, and 8-13 are rejected by virtue of dependency on claim 1.
Claim 1 recites the limitation “said reaction chamber” in line 21. There is insufficient antecedent basis for this limitation in the claim, thus the limitation is unclear. Specifically, the limitation is unclear if applicants are referring to the first reaction chamber or the second reaction chamber. The examiner suggests the Applicant amends claim 1 to read “said first reaction chamber” in line 21. Claims 3-6, and 8-13 are rejected by virtue of dependency on claim 1.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-6, and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Glezer et al (US 20040189311 A1; hereinafter “Glezer”; already of record) in view of He (CN 109709342 A; hereinafter “He”; English translation attached).
Regarding claim 1, Glezer teaches a portable device (Glezer; Abstract; assay cartridge; the examiner notes that the assay cartridge is capable of being transported, thus “portable”) for detecting and quantifying a concentration of a marker present in a sample of biological fluid (Glezer; para [296]; The assay modules (preferably, assay cartridges) may be used to carry out panels of assays. Suitable panels include panels of assays for analytes or activities associated…cardiac markers, e.g., one or more of Troponin T, Troponin I), said device comprising:
- a cartridge adapted to receive said biological fluid sample (Glezer; para [227]; a sample chamber 920) and comprising at least one reactive agent configured to bind to the marker defining an electrochemiluminescent solution (Glezer; para [297]; The one or more assay reagents may include, but are not limited to, binding reagents, preferably, labeled binding reagents, more preferably binding reagents labeled with electrochemiluminescent labels); said cartridge comprising an electrode cell configured to supply electrical energy to the electrochemiluminescent solution so as to trigger an electrochemiluminescence reaction of said electrochemiluminescent solution, generating a light signal representative of a concentration value of said marker in said biological fluid sample (Glezer; para [6]; the steps of applying electrical energy between first and second electrodes, measuring an assay dependent signal at the second electrode, applying electrical energy between the second electrode and a third electrode and measuring an assay dependent signal at the third electrode. The measured assay dependent signal is, preferably, selected from electrical current, electrical potential and/or electrode-induced luminescence);
- an analyzer (Glezer; para [100, 252]; a cartridge-based biochemical detection system 100), connected or connectable to said cartridge (Glezer; para [100, 252]; system housing, e.g., cartridge reader 105, would include an optical detector 110 and would be adapted and configured to receive and position cartridge 115) and configured to receive said light signal and analyze at least one property of said light signal so as to quantify a concentration of said marker in the biological fluid (Glezer; para [12]; the apparatus can be configured with an optical detector for detecting luminescence generated at the dedicated working and dual-role electrodes);
wherein said cartridge comprises:
- a receiving chamber for receiving said biological fluid sample, preferably with a conical or frustoconical shape (Glezer; para [187]; the sample chamber has an elongated shape with the two conduits being arranged to intersect at or near the opposing ends of the length; examiner notes the chamber would be frustoconical because the elongated shape of the chamber would have different size for the conduit and the sample inlet. The inlet is sized to receive an applicator, para [33], and the conduit allows capillary flow, para [152]), adapted to collect said biological fluid sample (Glezer; para [34]; sample chamber having sample introduction port with a sealable closure wherein the sample chamber is adapted to receive an applicator stick);
- a first reaction chamber, arranged in fluid communication with said receiving chamber and comprising a first reactive agent configured to bind to said marker of said biological fluid sample (Glezer; para [25]; detection chamber, preferably, a detection chamber having one or more binding domains having immobilized binding reagents connected to the sample and waste chambers via sample);
- a second reaction chamber comprising a second reactive agent configured to bind to said marker of said biological fluid sample (Glezer; para [29]; a second reagent chamber holding a second liquid reagent); said second reaction chamber comprising a covering element transparent to the electromagnetic radiation generated by said electrochemiluminescence reaction to allow the reception of the electromagnetic radiation by the analyzer (Glezer; para [31]; at least a portion of one wall of the detection chamber may be substantially transparent to allow optical monitoring of materials in the detection chamber);
a washing chamber, arranged in fluid communication with said second reaction chamber (Glezer; para [35]; the waste chamber may be connected to the detection chamber via a waste conduit and the wash reagent chamber connected to the sample conduit via a wash conduit), a hydrophilic absorption element dimensioned and positioned to passively wick an excess portion of the electrochemiluminescent solution from the second reaction chamber, the excess portion including at least one of: a portion of the biological fluid sample, a portion of the first reactive agent not bound to the marker, and a portion of the second reactive agent not bound to the marker (Glezer; para [206]; the waste chambers contain a water absorbing material, such as a sponge, that retains waste fluid and prevents leakage of the waste fluid on disposal of a cartridge; the examiner notes that the sponge is “hydrophilic” as it absorbs water).
Note: The instant claims contain a large amount of functional language (ex: "configured to... "). However, functional language does not add any further structure to an apparatus beyond a capability. Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. As such, it is deemed that the claimed at least one reactive agent, electrode cell, analyzer, first reactive agent, second reactive agent, and absorption element is not differentiated from Glezer (see MPEP §2114).
Glezer does not teach wherein the second reaction chamber is arranged in fluid communication with said first reaction chamber, said reaction chamber being interposed between the receiving chamber and the second reaction chamber, and wherein the second reaction chamber is interposed between the first reaction chamber and the washing chamber.
However, He teaches an analogous art of a fluidic cartridge (He; Abstract) comprising a first reaction chamber, arranged in fluid communication with said receiving chamber and comprising a first reactive agent configured to bind to said marker of said biological fluid sample (He; Fig. 5; page 11; para [7]; pushing sample to be detected continuously along the flow channel into the first reaction chamber 23, then, pressing the first reagent plug 13, first reagent into first reaction chamber 23); a second reaction chamber, arranged in fluid communication with said first reaction chamber, said reaction chamber being interposed between the receiving chamber and the second reaction chamber (He; Fig. 5; page 12; para [2]; the first buffer solution in the reaction cavity 23, first reagent, the to-be detected sample to first mixing cavity 27, then into the second reaction chamber 24, first reaction chamber of a liquid 23 can only enter the first mixing cavity 27 along the flow passage). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to arrange the second reaction chamber of Glezer in the manner of ----being arranged in fluid communication with said first reaction chamber, said reaction chamber being interposed between the receiving chamber and the second reaction chamber as taught by He as this is a known and suitable arrangement for the second reaction chamber in the art. Further, it is a matter of engineering design to arrange the ----second reaction chamber in different ways, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP §2144.04). Finally, one would have a reasonable expectation of success by changing the arrangement of the second reaction chamber to the claimed limitation as He teaches this arrangement is a known and suitable arrangement in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP §2143, A). The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP §2143, B).
Glezer is modified to connect the second reaction chamber to the first reaction chamber as taught by He, and the washing chamber is positioned after the second reaction chamber as discussed above. Thus, modified Glezer teaches wherein the second reaction chamber is interposed between the first reaction chamber and the washing chamber.
Regarding claim 3, modified Glezer teaches the device claim 1, wherein said electrode cell is operatively arranged in a bottom portion of said second reaction chamber, said electrode cell having three-electrode type and being configured to generate a potential difference between two of said three electrodes (Glezer; para [6, 7]; a plurality of biochemical assays using a plurality of electrodes is disclosed. The method comprises the steps of applying electrical energy between first and second electrodes, measuring an assay dependent signal at the second electrode, applying electrical energy between the second electrode and a third electrode and measuring an assay dependent signal at the third electrode…the plurality of electrodes can be arranged within a flow cell. In a preferred embodiment). The limitations are directed to the function and/or the manner of operating the electrode cell, all the structural limitations of the claim has been disclosed Glezer and the electrode cell of Glezer is capable of “generat[ing] a potential difference between two of said three electrodes”. As such, it is deemed that the claimed electrode cell is not differentiated from the electrode cell of Glezer (see MPEP §2114).
Regarding claim 4, modified Glezer teaches the device according to claim 1, wherein said first reaction chamber comprises a microfluidic channel, interposed between said receiving chamber and said second reaction chamber, configured for a transport of said biological fluid sample from said receiving chamber to said second reaction chamber (Glezer; para [24, 29]; The detection chamber is connected to the sample chamber via a sample conduit…a second reagent chamber conduit connecting the second reagent chamber with the sample conduit); said first reactive agent being applied at least on the walls of said microfluidic channel and being configured to detach from said walls when in contact with said biological fluid sample (Glezer; para [30]; the detection chamber may comprise one or more electrodes having binding reagents immobilized thereon). The limitations are directed to the function and/or the manner of operating the microfluidic channel, all the structural limitations of the claim has been disclosed Glezer and the a microfluidic channel of Glezer is capable of “transport[ing] said biological fluid sample from said receiving chamber to said second reaction chamber”. As such, it is deemed that the claimed a microfluidic channel is not differentiated from the a microfluidic channel of Glezer (see MPEP §2114).
Regarding claim 5, modified Glezer teaches the device according to claim 1, wherein said first reaction chamber is at least partially coincident with said receiving chamber (Glezer; para [24]; The detection chamber is connected to the sample chamber via a sample conduit); said first reactive agent being applied to a bottom wall of said receiving chamber and being configured to detach from said bottom wall when in contact with said biological fluid sample (Glezer; para [30]; the detection chamber may comprise one or more electrodes having binding reagents immobilized thereon).
Regarding claim 6, modified Glezer teaches the device according to claim 1, wherein said cartridge comprises a chemical and/or physical barrier, interposed between the receiving chamber and the second reaction chamber, configured to break apart after a certain period of time from a first contact between said barrier and said biological fluid sample so as to slow down a movement of said biological fluid sample from said receiving chamber to said second reaction chamber (Glezer; para [186]; the sample chamber may also include a filter for, e.g., removing particulate matter that may be present within the sample; examiner notes that the sample permeates the filter, depending on the material, thus “breaking apart” to slow down movement); said period of time being between 2 minutes and 10 minutes (Glezer; para [168]; The cartridge was incubated for 8 minutes to allow the binding reactions to occur, the substrate was then washed by passing MSD Assay Buffer into the flow cell and ECL was measured). The limitations are directed to the function and/or the manner of operating the chemical and/or physical barrier, all the structural limitations of the claim has been disclosed Glezer and the a chemical and/or physical barrier of Glezer is capable of “break[ing] to break apart after a certain period of time from a first contact between said barrier and said biological fluid sample so as to slow down a movement of said biological fluid sample from said receiving chamber to said second reaction chamber”. As such, it is deemed that the claimed a chemical and/or physical barrier is not differentiated from the a chemical and/or physical barrier of Glezer (see MPEP §2114).
Regarding claim 8, modified Glezer teaches the device according to claim 1, wherein said cartridge comprises a connector configured for a reversible coupling with a respective receiving portion of said analyzer; said connector being configured to activate said electrode cell when said cartridge is connected to said analyzer (Glezer; para [95]; The assay module may comprise the necessary electronic components and/or active mechanical components for carrying out an assay measurement, e.g., one or more sources of electrical energy…the reader would also have the appropriate electrical, fluidic and/or optical connections to the assay module for carrying out an assay on the assay module). The limitations are directed to the function and/or the manner of operating the connector, all the structural limitations of the claim has been disclosed Glezer and the connector of Glezer is capable of “activat[ing] said electrode cell when said cartridge is connected to said analyzer”. As such, it is deemed that the claimed connector is not differentiated from the connector of Glezer (see MPEP §2114).
Regarding claim 9, modified Glezer teaches the device according to claim 1, wherein said analyzer (Glezer; para [252]; The cartridge reader 2300) comprises:
- an optical sensor, arranged above said covering element and oriented in the direction of said covering element when said cartridge is connected to said analyzer, said optical sensor being configured to measure a light intensity value of the light signal emitted by said electrochemiluminescence reaction (Glezer; para [235]; cartridge body 1100 is adapted and configured to be an optical detection window and is arranged in optical registration with the electrodes to allow optical detection of luminescence generated by the electrode array);
- a control unit (Glezer; para [261]; a single embedded microprocessor may be used to control the electronics and to coordinate cartridge operations. Additionally, the microprocessor may also support an embedded operator interface, connectivity and data management operations), connected to said optical sensor and configured to determine the concentration of said marker as a function of the light intensity value measured by the optical sensor (Glezer; para [278]; Predefined assay-specific conversion parameters may be used to derive concentrations/results from the measured ECL counts); said control unit being further configured to generate information content representative of the concentration of said marker in said biological fluid sample (Glezer; para [278]; predefined assay-specific conversion parameters may be used to derive concentrations/results from the measured ECL counts; e.g., empirically derived from test data or computed from theoretical predictions/models); and
- a video and/or audio emission system connected to said control unit to receive said information content and configured to emit a visual and/or acoustic signal corresponding to said information content (Glezer; para [261]; The embedded operator interface can preferably utilize an integrated display 2360 and/or integrated data entry device 2355).
The limitations are directed to the function and/or the manner of operating the optical sensor, all the structural limitations of the claim has been disclosed Glezer and the optical sensor of Glezer is capable of “measur[ing] a light intensity value of the light signal emitted by said electrochemiluminescence reaction”. As such, it is deemed that the claimed optical sensor is not differentiated from the optical sensor of Glezer (see MPEP §2114).
Regarding claim 10, modified Glezer teaches the device according to claim 9, wherein said analyzer comprises a communication system configured to transmit said information content to an external receiving unit (Glezer; para [261]; For example, the cartridge reader can be configured with external communications ports (e.g., RS-232, parallel, USB, IEEE 1394, and the like) for connection to a general purpose computer system).
Regarding claim 11, modified Glezer teaches the device according to claim 1, wherein said electrode cell comprises a working electrode, a reference electrode and an auxiliary electrode (Glezer; para [6, 7]; applying electrical energy between first and second electrodes, measuring an assay dependent signal at the second electrode, applying electrical energy between the second electrode and a third electrode and measuring an assay dependent signal at the third electrode); said working electrode being made of vitreous carbon or gold or platinum; said reference electrode being made of silver or silver chloride; said auxiliary electrode being made of vitreous carbon or gold or platinum (Glezer; para [105]; the electrode may comprise a metal such as gold, silver, platinum, nickel, steel, iridium, copper, aluminum, a conductive alloy). Examiner notes that the working and reference electrode is interpreted as the second and third electrode as these electrodes are used for detection of the assay. The auxiliary electrode is interpreted as the first electrode as this electrode provides the electrical energy.
Regarding claim 12, modified Glezer teaches the device according to claim 1, wherein said receiving chamber comprises a sampling element configured to perform an extraction of said biological fluid sample from a user when in contact with the user, said sampling element comprising a fingerstick or a lancing device (Glezer; para [187]; Applicator stick is used herein to refer to a sample collection device comprising an elongated handle (preferably a rod or rectangular prism) and a sample collection head (preferably comprising an absorbant material or, alternatively, a scraping blade) configured to collect sample from a surface or biological tissue) and includes sample collection swabs and tissue scrapers). The limitations are directed to the function and/or the manner of operating the sampling element, all the structural limitations of the claim has been disclosed Glezer and the sampling element of Glezer is capable of “perform[ing] an extraction of said biological fluid sample from a user when in contact with the user”. As such, it is deemed that the claimed sampling element is not differentiated from the sampling element of Glezer (see MPEP §2114).
Regarding claim 13, modified Glezer teaches the device according to claim 1, comprising a plurality of cartridges reversibly connectable to the analyzer (Glezer; para [93]; assay modules (e.g., assay cartridges, assay plates, etc.) for carrying out a plurality of assay measurements; examiner notes that a plurality of cartridges may be used which are connected to the cartridge reader para [252]), each cartridge comprising a respective reactive agent configured to bind to a respective marker (Glezer; para [296]; The assay modules (preferably, assay cartridges) may be used to carry out panels of assays. Suitable panels include panels of assays for analytes or activities associated with a specific biochemical system).
Response to Arguments
Applicant’s arguments filed, 11/11/2025, have been considered and some of the arguments are found to be persuasive. However, those arguments are directed towards the claim amendments. The examiner notes that the previous prior art rejection is withdrawn and a new prior art rejection is applied to address the claim amendments.
In the Applicants’ arguments, on page 10, the Applicant argues that “configure to” is not construed as “merely capable of after modification”. The examiner does not rely on modifications to teach the functional limitations. Additionally, the functional claim limitations are cited and taught above by Glezer. Further, as Applicant cited, the decision demonstrates that functional limitations, coupled with a disclosure that limits the function of the device to a specific design, may overcome the prior art. The claim amendments do not structurally overcome the new prior art rejection as taught by Glezer in view of He.
In the Applicants’ arguments, on pages 11-12, the Applicant argues Glezer does not teach an absorbent element. The examiner respectfully disagrees. Glezer teaches a washing chamber, arranged in fluid communication with said second reaction chamber (Glezer; para [35]; the waste chamber may be connected to the detection chamber via a waste conduit and the wash reagent chamber connected to the sample conduit via a wash conduit), a hydrophilic absorption element dimensioned and positioned to passively wick an excess portion of the electrochemiluminescent solution from the second reaction chamber, the excess portion including at least one of: a portion of the biological fluid sample, a portion of the first reactive agent not bound to the marker, and a portion of the second reactive agent not bound to the marker (Glezer; para [206]; the waste chambers contain a water absorbing material, such as a sponge, that retains waste fluid and prevents leakage of the waste fluid on disposal of a cartridge; the examiner notes that the sponge is “hydrophilic” as it absorbs water).
In response to applicant's argument, on page 12, that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., capillary/passive removal from the detection chamber to waste) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant does not positively claim “capillary action” of the channel. Examiner notes that Glezer teaches the chambers are connected via conduits.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.Q.L./Examiner, Art Unit 1796 /DUANE SMITH/ Supervisory Patent Examiner, Art Unit 1759