DETAILED ACTION
Notice of Pre-AIA or AIA Status
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 31, 2025 has been entered.
Claims 1-5, 7, 8, 10-12, 14-20 and 22-24 remain pending. Applicant amended claim 1.
The outstanding claim objection has been withdrawn in light of the amendment.
Response to Arguments
With respect to independent claim 1 and claims dependent thereon, Applicant’s arguments with respect to the patentability of the claims are moot. The amendment necessitated the new ground of rejection set forth below.
With respect to independent claim 12 and claims dependent thereon, Applicant’s arguments with respect to the patentability of the claims have been fully considered but they are not persuasive.
Applicant argues that claim 12 is patentable over the combination of Terbrueggen and Gussman because the disclosure of Gussman “is so untethered to Terbruegg[e]n that a person of ordinary skill would gain nothing from Gussman”. Remarks 8. The argument is not persuasive. The disclosure of Gussman relied upon is limited to the concept of tracking whether disposable articles have been used such that the articles are not re-used. Gussman teaching the use of a bar code reader to ensure that a “used” article is not reused is a problem that is pertinent to the system taught by Terbrueggen (reusing “used” cartridges would lead to sample contamination and also malfunction given that pumps inside the Terbrueggen cartridge are intended for single-use, see [0116]). The fact that the articles disclosed by Gussman are “tubes” whose intended use is unrelated to the intended use of the cartridges taught by Terbrueggen does not undermine the motivation set forth in the rejection. Consequently, the examiner maintains that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the disclosure of the references.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7, 8, 10, 11 and 22-24 are rejected under 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors at the time the application was filed, had possession of the claimed invention.
Claim 1 was amended to recite a step of determining the concentration of an analyte in a sample, and using the determined concentration to recalibrate the reader assembly. The specification does not provide support for the amendment. According to the claim, it is unknown whether the sample even contains the analyte, meaning the concentration of the analyte is initially unknown. The specification does not provide support for a method in which a reader assembly is recalibrated (or even calibrated) using an analyte whose concentration is initially unknown.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 7, 8, 10, 11 and 22-24 are rejected under 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, a joint inventor, or the applicant regards as the invention.
Claim 1 recites “each level”. The limitation presumably refers to a plurality of levels that are previously recited in the claim. However, there is no antecedent basis for the plurality of levels. It is unclear to what “each level” refers.
Relatedly, claim 1 recites a step of “recalibrating the reader assembly” without reciting a step of calibrating the reader assembly. It is unclear whether the claim intends to implicitly recite a step of calibrating the reader assembly, and if so, it is unclear how the initial calibration is performed. As discussed above, the recalibration step involves the use of “each level’ for which there is no context. It is unclear whether the initial calibration step (which is unclaimed) involves “each level” and thus provides context for the limitation “each level”. If so, the initial calibration step should be positively recited.
Claims not explicitly rejected are rejected due to dependency.
Claim Rejections - 35 USC § 103
Claims 1-4, 7, 8, 10, 11, 20, 22 and 24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Glezer (US 2004/0189311 A1) in view of Terbrueggen (US 2004/0053290 A1) and Lett et al. (“Lett”) (US 2003/0018457 A1).
With respect to claim 1, Glezer discloses a method for detecting the presence or absence of an analyte contained in a sample, the method comprising:
receiving a cartridge 115 (see abstract and Fig. 1) pre-loaded with a reagent (see [0197]) into a reader assembly (reader apparatus 105) (see abstract and Fig. 1), the cartridge comprising:
a sample unit (sample chamber) configured to receive the sample (see [0034]);
a rupturable foil seal (see [0027] and [0197]); and
an assay assembly, wherein the assay assembly comprises:
a reaction site (detection chamber) including the first reagent (see [0034]), the reagent being configured to undergo a reaction if the analyte is present in the sample such that a signal is produced indicating the presence of the analyte (see [0038]);
receiving a protocol associated with the cartridge at the reader assembly based on an identifier of the cartridge (see [0251]);
rupturing the foil seal (see [0027], [0198]-[0199], [0253] and [0270]);
actuating a pump to flow a portion of the sample to the assay assembly (see [0272] and [0274]), wherein the analyte, if present, reacts with the reagent at the reaction site and produces the signal indicating the presence of the analyte (see [0038]);
using a detection assembly to determine whether the signal was detected (see [0293]), and if so, determining its concentration level (see [0282]);
storing the results of the assay (see [0261]); and
recalibrating the reader assembly by calibrating against a difference between the determined concentration level and the concentration of the analyte in a control sample spiked with a known, predetermined concentration of the analyte (see [0214]).
The method taught by Glezer differs from the claimed invention in that Glezer does not disclose actuating a piezoelectric element while conducting the assay. In addition, the disclosure of Glezer is silent regarding wirelessly providing the result of the assay. Lastly, Glezer does not disclose that the recalibration utilizes a sum of squares calculation.
Regarding the piezoelectric element, Glezer discloses that the sample can be moved within the cartridge using positive and negative pressure (see [0039]). Based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any conventional pumping mechanism to move the sample within the cartridge, for example a piezoelectric element, as taught by Terbrueggen (see [0119]). If the modification is made, then the method would naturally further comprise a step of actuating the piezoelectric element.
Regarding wireless transmission of the results, Terbrueggen also discloses a wireless communication system associated with an assaying apparatus for wirelessly transmitting data (e.g. the results of an assay) to an off-apparatus location (e.g. doctor’s office, insurance provider) (see [0457]-[0458]) so that the data can be conveyed to a patient. In light of the disclosure of Terbrueggen, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the reader assembly taught by Glezer with a wireless communication system, and using the communication system to wirelessly transmit the results of the assay to an off-assembly location (e.g. a doctor’s office).
Regarding the sum of squares calculation, use of such calculation for the purpose of calibrating measurement data is well-known in the art. For example, Lett discloses that sum of squares calculation is a conventional way of determining error for the purpose of calibrating a measurement (see [0081]). In light of the disclosure of Lett, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used sum of squares calculation when performing the recalibration taught by Glezer.
With respect to claim 2, as discussed above, the modified method comprises the step of using a communication assembly to wirelessly transmit the detected signal. Moreover, based on the intended recipient of the detected signal (e.g. doctor, patient), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have transformed the signal into a digital representation (e.g. positive/negative, concentration values) that can be understood by the recipient.
With respect to claim 3, the protocol is received via a wired connection from an external device (a reader attached to the reader assembly) (see [0255] of Glezer).
With respect to claim 4, the identifier is a bar code disposed on the cartridge (see [0251]).
With respect to claim 7, the detection of the signal is achieved via a charge coupled device having multiple detection areas (see [0104] of Glezer).
With respect to claim 8, the signal is a luminescent signal (see abstract of Glezer).
With respect to claim 10, a portion of the reaction site is transparent (see [0014]), meaning that a bounding area of that portion must be constructed from an optically opaque material.
With respect to claim 11, the cartridge can further comprise a diluent. (see [0194]). Naturally, an assay involving the diluent would comprise a step of diluting the sample.
With respect to claim 20, the reagent can be liquid or dry (see [0004]). If the reagent is dry, the cartridge comprises a separate liquid for reconstituting the reagent before the reagent reacts with the sample (see [0195] of Glezer).
With respect to claim 22, the sample and the reagent are retained within the cartridge (in the waste chamber) after detecting the signal (see [0036] of Glezer).
With respect to claim 24, the foil seal is ruptured by an actuation plate (flexible chamber cover layer) of the reader assembly (see [0199] of Glezer).
Claim 5 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Glezer in view of Terbrueggen and Lett as applied to claims 1-4, 7, 8, 10, 11, 20, 22 and 24 above, and further in view of Friedman (US 2005/0177057 A1).
With respect to claim 5, the method further comprises detecting the identifier via an identifier detector (bar code reader), and subsequently relaying the protocol to the reader assembly (see [0255]). Because the protocol itself or the information needed to determine the protocol is encoded in the identifier, the method taught by Glezer does not involve an external device that determines the protocol. However, instead of encoding the protocol in the cartridge identifier, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the reader assembly to connect to an external device (e.g. a server) upon scanning the cartridge identifier and download the protocol from the external device at the time of testing, as taught by Friedman (see [0040]). The modification would reduce the information encoded on the identifier (e.g. if the cartridge is compatible with different models of the reader assembly, there would be no need to encode separate protocols for each reader assembly) and/or allow the reader assembly to obtain the most updated version of the protocol that is compatible with the reader assembly (e.g. newer models of the reader assembly may require different protocols).
Claim 23 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Glezer in view of Terbrueggen and Lett as applied to claims 1-4, 7, 8, 10, 11, 20, 22 and 24 above, and further in view of Farnam (US 2008/0124749 A1).
The combination of Glezer, Terbrueggen and Lett do not disclose a means for confirming the volume of the sample that is being analyzed. However, Farnam discloses a system configured to conduct an assay (see Fig. 1A), wherein the system is configured to generate an error if insufficient sample volume is transferred in a chip that performs the assay (see [0048]). In light of the disclosure of Farnam, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the sample volume detection means taught by Farnam into the modified Glezer reader assembly so that the assay is reliable.
Claims 12 and 14-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Terbrueggen in view of Gussman (US 4,902,969).
Terbrueggen discloses a method for analyzing a biological fluid sample, the method comprising:
inserting a cartridge into a reader assembly 137 (see Figs. 4A and 4B), the cartridge comprising (see Fig. 1A):
a sample unit 100 containing the sample;
a cartridge identifier (see [0428]), and
an assay assembly 102, wherein the assay assembly comprises a plurality of distinct arrays (see [0155]-[0156]), each array comprising biological moieties in wells (see [0148]) for performing multiple assays on a single sample (see [0060]), wherein the biological moieties comprise a control reagent (probe) configured to react with a control analyte (sample of known identity/concentration) (see [0376]);
receiving a protocol associated with the cartridge at the reader assembly, based on the cartridge identifier (see [0428]);
flowing a portion of the sample to the assay assembly 102 based on receipt of the protocol (see [0061] and [0428]) such that the sample reacts with the reagent in each well and the control analyte reacts with the control reagent, and produces optical signals indicating the presence of the analyte (see [0285] and [0463]);
detecting the optical signals with a detection assembly included in the reader assembly (see [0442] and [0463]); and
transmitting the signals (see [0191] disclosing analysis and interpretation of signals) to an external device (see [0451])*.
*The limitation “for aggregation of the plurality of signals by the external device” merely conveys an intended use of performing the “transmitting” step. Consequently, Terbrueggen need not disclose aggregating the signals to anticipate the “transmitting” step.
The method taught by Terbrueggen differs from the claimed invention in that Terbrueggen does not disclose that the reader assembly is configured to transmit an alert upon determining that a cartridge has been used. In addition, Terbrueggen does not explicitly disclose that the flow of the sample is achieved by actuating an actuating element.
Regarding the alert, Gussman discloses an automated system that processes single-use articles (tubes), wherein the articles bear barcodes to track their processing. Via the barcodes, the system is configured to ascertain whether a tube has already been processed such that it is not re-processed (see lines 53-60, col. 18). In light of the disclosure of Gussman and given that the cartridges taught by Terbrueggen are single-use cartridges, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the reader assembly taught by Terbrueggen to determine, via the cartridge identifier, whether a cartridge has been previously processed. The modification would eliminate erroneous results caused by contaminated cartridges. Naturally, in the event that the reader assembly determines that a cartridge has been used, it also would have been obvious to one of ordinary skill in the art to have configured the reader assembly to generate an alarm.
Regarding the actuating element, Terbrueggen discloses that pumps for facilitating flow within the cartridge may be provided “off chip”, specifically within devices configured to receive the cartridges (see [0151]). Based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the reader assembly 137 with an actuator (pump), and use the actuator to flow the sample to the reaction sites.
With respect to claim 14, Terbrueggen further discloses a step of analyzing the signals (see [0191]) using an external device (see [0451]). Naturally, the analysis can only be conducted after the signals are transmitted and aggregated.
The limitation “to perform a trend analysis of the presence of the analyte contained in the sample at various time points over a given period of time” is recitation of intended use which does not further limit the claimed analysis. In addition, the limitation (i.e. various time points over a given period of time) is too abstract to further limit the scope of the claimed analysis in any way.
With respect to claim 15, Terbrueggen discloses that the reader assembly can receive calibration information (see [0428]). Based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the calibration information to conduct on-board calibration of the assay assembly.
With respect to claim 16, the sample comprises one of blood and urine (see [0062]).
With respect to claim 17, as discussed above, the cartridge taught by Terbrueggen comprises a plurality of arrays for detecting different analytes/conducting different assays (see [0155]-[0156]). Consequently, it is evident that the modified Terbrueggen method would detect a plurality of different analytes that generate distinct signals corresponding to the different reactions at different reaction sites.
With respect to claim 18, detecting of the optical signals further comprises detecting that a luminescent signal is present at a particular reaction site (see [0442]).
With respect to claim 19, the system disclosed by Terbrueggen further comprises a temperature sensor for monitoring the temperature of the sample in the cartridge (see [0017]). Naturally, the modified Terbrueggen method would comprise a step of detecting a second signal from a temperature sensor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796
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