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 Arguments
Applicant's arguments filed on 03/02/2026 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. § 102(a)(1) rejection of claim 1, the applicant amends claim 1 and recites that “The cited references do not disclose teach or suggest the features of amended claim 1.
Specifically, the cited references do not teach or suggest moving a heater a distance away from a sample preparation cartridge in response to a temperature meeting a temperature condition. With respect to previous dependent claim 7, the Office Action pointed to Chen for a controller moving a heater from a sample position to a rest position but indicates that Chen does not teach or suggest moving the heater a distance from the sample position and points to Ririe. However, the combination of Chen does not teach or suggest moving a heater a distance from a sample position to a rest position in response to a monitored temperature meeting a temperature condition […] Chen does not describe reorienting heaters based on a monitored temperature.” (see remarks, pg. 6-7).
However, given the broadest reasonable interpretation of the amended claims, Chen’s prior art (US PAT 7799521 B2, as cited in the IDS and previous action) still anticipates claim 1. Chen disclosing a first heater translatable between a first orientation in which the first heater affects the temperature of the reaction mixture and a second orientation in which the first heater does not substantially affect the temperature of the reaction mixture, during thermal cycling (see Chen, claim 1). The language in both when broadly interpreted is found to be functionally indistinguishable from one another, especially when applied as a system/apparatus claim. Positioning and distance are broad enough that the citation of Chen above still anticipates it by moving the heater between a first and second orientation and is indistinguishable from the application’s amended claim. Additionally, the movement of the heater is done during thermal cycling/temperature cycling, and the sample or heated chamber temperatures would reach a target temperature for a period of time before shifting the heater a distance towards or from the sample as part of thermal cycling.
Therefore, the examiner is maintaining the 35 U.S.C. § 102(a)(1) rejection of independent claim 1, as well as independent claim 6 and 11 for the same reasons given above. Dependent claims 2-5, 8-10, and 12-15 additionally have its 35 U.S.C. § 102(a)(1) and 35 U.S.C. § 103 rejections maintained.
The prosecution may be furthered by incorporating specific structural elements into the apparatus/system claims, that would define over the prior art.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 5-6 and 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen (US PAT 7799521 B2, as cited in the IDS).
Regarding claim 1, Chen teaches A device comprising: a heater (see col. 2 lines, 58-65, disclosing the processing station including an energy transfer element for transferring energy to or from the content within the sample vessel. The energy transfer element can be an electronic heat element.); a temperature sensor to monitor changes in temperature caused by the heater (see col. 2-3, lines 66-9 and col 11, lines 39-62, disclosing temperature sensor being coupled to the control system to monitor temperature at the processing station, and the energy transfer element.); a mechanical device to move the heater between a sample position and a rest position (see col. 3, lines 15-21, discloses a driver coupled to the compression member to selectively move the compression member and thereby compress the sample vessel within the opening. The driver can be, for example, a motor coupled to the compression member by a cam. Alternatively, the driver can be an electromagnetic actuating mechanism. Further see col 11, lines 38-62, Fig 3., disclosing the energy transfer element 48 embedded in or otherwise coupled to the compression member 22. See also Claim 1, further disclosing a first heater translatable between a first orientation in which the first heater affects the temperature of the reaction mixture and a second orientation in which the first heater does not substantially affect the temperature of the reaction mixture, during thermal cycling.); and a circuit communicatively coupled to the heater, the temperature sensor, and the mechanical device, the circuit configured to: control the mechanical device to move the heater to the sample position; control the heater to heat at the sample position; monitor, via the temperature sensor, the temperature; and in response to the temperature meeting a temperature condition, control the mechanical device to move the heater from the sample position to the rest position (see col. 11, lines 39-62, disclosing the energy transfer element coupled to a control system that controls the energy transferred to or from the sample vessel. The control system can be a component of the CPU or an independent system. The control system can further include a temperature sensor. Further see col. 15, lines 1-18 and col. 15-16, lines 61-13, Fig. 7, disclosing a temperature control system 152, and a driver control system 160, both working in communication as components of CPU 174. See also Claim 1, further disclosing a first heater translatable between a first orientation in which the first heater affects the temperature of the reaction mixture and a second orientation in which the first heater does not substantially affect the temperature of the reaction mixture.).
Regarding claim 3, Chen teaches the device of claim 1, wherein the temperature sensor is located at the heater (see claim 13, disclosing wherein each heater element includes a temperature sensor.).
Regarding claim 5, Chen teaches the device of claim 1, wherein the heater is further configured to heat a sample preparation cartridge module at the sample position to affect a biological or chemical process in the sample preparation cartridge module (see col. 8-9, lines 60-16, discloses effecting a chemical or biological reaction within a segment of the sample vessel by, for example, transferring thermal energy to or from the sample.).
Regarding claim 6, Chen teaches A device comprising: a heater (see col. 2 lines, 58-65, disclosing the processing station including an energy transfer element for transferring energy to or from the content within the sample vessel. The energy transfer element can be an electronic heat element.); a temperature sensor to monitor changes in temperature caused by the heater (see col. 2-3, lines 66-9 and col 11, lines 39-62, disclosing temperature sensor being coupled to the control system to monitor temperature at the processing station, and the energy transfer element.); a mechanical device to move the heater between a sample position and a rest position (see col. 3, lines 15-21, discloses a driver coupled to the compression member to selectively move the compression member and thereby compress the sample vessel within the opening. The driver can be, for example, a motor coupled to the compression member by a cam. Alternatively, the driver can be an electromagnetic actuating mechanism. Further see col 11, lines 38-62, Fig 3., disclosing the energy transfer element 48 embedded in or otherwise coupled to the compression member 22.); and a circuit communicatively coupled to the heater, the temperature sensor, and the mechanical device, the circuit configured to: control the heater to generate heat; monitor, via the temperature sensor, the temperature; and control the mechanical device to adjust a position of the heater, relative to the sample position and the rest position, based on the temperature, to control a heating cycle (see col. 11, lines 39-62, disclosing the energy transfer element coupled to a control system that controls the energy transferred to or from the sample vessel. The control system can be a component of the CPU or an independent system. The control system can further include a temperature sensor. Further see col. 15, lines 1-18 and col. 15-16, lines 61-13, Fig. 7, disclosing a temperature control system 152, and a driver control system 160, both working in communication as components of CPU 174. See also Claim 1, further disclosing a first heater translatable between a first orientation in which the first heater affects the temperature of the reaction mixture and a second orientation in which the first heater does not substantially affect the temperature of the reaction mixture.).
Regarding claim 8, Chen teaches the device of claim 6, wherein the circuit is further configured to control the mechanical device to adjust the position of the heater, to control the heating cycle, by adjusting a mechanical pressure or a mechanical force at the sample position (see col. 3, lines 15-21, disclosing a driver coupled to the compression member to selectively move the compression member and thereby compress the sample vessel within the opening. The driver can be, for example, a motor coupled to the compression member by a cam. Alternatively, the driver can be an electromagnetic actuating mechanism. See also col 11, lines 38-62, Fig. 3, disclosing the energy transfer element 48 embedded in or otherwise coupled to the compression member 22. Further see col. 15-16, lines 61-13, Fig 7, disclosing that a driver control system 160 is coupled to the drivers 24 to control the operation of the drivers 24. The driver control system 160 is coupled to the CPU 174 such that the sample incubation time period, the pressure and the sample moving speed within the sample vessel can be controlled and coordinated by the CPU 174 to achieve the best reaction results.)
Regarding claim 9, Chen teaches the device of claim 6, wherein the circuit is further configured to control the mechanical device to adjust the position of the heater, to control the heating cycle, by controlling a time period that the heater is at the sample position (see col. 17, lines 43-67, Fig. 13G, disclosing the sample can be heated or cooled by the third processing station 150C for a set time period.).
Regarding claim 10, Chen teaches the device of claim 6, wherein the circuit is further configured to control the heating cycle by controlling power to the heater (see col. 16, lines 14-26 Fig. 7, disclosing that each of the energy transfer elements is coupled to the temperature control system 152 to maintain the associated processing station within a selected temperature range.).
Regarding claim 11, Chen teaches a method comprising: monitoring, at a device, via a temperature sensor (see col. 2-3, lines 66-9 and col 11, lines 39-62, disclosing temperature sensor being coupled to the control system to monitor temperature at the processing station, and the energy transfer element.), changes in temperature caused by a heater attached to a mechanical device, the mechanical device configured to move the heater between a sample position and a rest position (see col. 3, lines 15-21, discloses a driver coupled to the compression member to selectively move the compression member and thereby compress the sample vessel within the opening. The driver can be, for example, a motor coupled to the compression member by a cam. Alternatively, the driver can be an electromagnetic actuating mechanism. Further see col 11, lines 38-62, Fig 3., disclosing the energy transfer element 48 embedded in or otherwise coupled to the compression member 22.); controlling, at the device, power to the heater, based on the temperature relative to a target temperature and a threshold temperature (see col. 16, lines 14-26 Fig. 7, disclosing that each of the energy transfer elements is coupled to the temperature control system 152 to maintain the associated processing station within a selected temperature range.); and controlling, at the device, the mechanical device to move the heater, relative to the sample position, based on the temperature relative to the target temperature and the threshold temperature (see col. 15, lines 1-18 and col. 15-16, lines 61-13, Fig. 7, disclosing a temperature control system 152, and a driver control system 160, both working in communication as components of CPU 174.See also Claim 1, further disclosing a first heater translatable between a first orientation in which the first heater affects the temperature of the reaction mixture and a second orientation in which the first heater does not substantially affect the temperature of the reaction mixture.).
Regarding claim 12, Chen teaches the method of claim 11, wherein controlling the mechanical device to move the heater, based on the temperature, relative to the target temperature and the threshold temperature, comprises: in response to the temperature reaching the threshold temperature, moving the heater away from the sample position until the temperature is at or below the target temperature.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Chen, in view of Gubatayao et al (US PG-Pub 20180135102 A1, as cited in the IDS).
Regarding claim 2, Chen teaches one or more temperature sensors, coupled to the temperature control system 152, can be positioned proximate the processing stations 150A-150C to monitor the temperature of the stations (see Chen, Fig. 7, col 16, lines 14-26). Each of the processing stations 150A-150C can be maintained at a pre-selected temperature range controlled by a temperature control system 152 and a CPU 174 (see Chen, Fig. 7, col. 15, lines 1-18). Chen further teaches processing a sample can include the step of heating the sample in the first segment of the sample vessel to a first temperature. The step can continue to include the step of heating the sample to a second temperature in the second segment, where the first temperature is different from the second temperature (see Chen, col. 4, lines 43-55, claim 18).
Chen fails to teach that in response to the temperature meeting the temperature condition, control the heater to stop heating.
However, in the analogous art of scanning real-time microfluidic thermocycler, Gubatayao et al teaches that the heating may be controlled by periodically turning the current on and off to a respective heater with varying pulse width modulation (see Gubatayao et al, [0085]). Gubatayao et al further teaches that while heating may be accomplished by running current through a microfluidic or electronic circuit, cooling may be “passive” in that only convection between the microfluidic chamber and is used to reduce the chamber's temperature (see Gubatayao et al, [0102]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature control system of Chen to incorporate turning the current of the heating element on and off (as taught by Gubatayao et al), for the benefit of managing a plurality of thermal cycling profiles in conjunction with directing a sensor array across each of a plurality of reaction chambers, for performing simultaneous nucleic acid amplification and detection in automating the patient diagnostic assaying process (see Gubatayao et al, Abstract, [0004]).
Regarding claim 13, Chen teaches one or more temperature sensors, coupled to the temperature control system 152, can be positioned proximate the processing stations 150A-150C to monitor the temperature of the stations (see Chen, Fig. 7, col 16, lines 14-26). Each of the processing stations 150A-150C can be maintained at a pre-selected temperature range controlled by a temperature control system 152 and a CPU 174 (see Chen, Fig. 7, col. 15, lines 1-18). Chen further teaches processing a sample can include the step of heating the sample in the first segment of the sample vessel to a first temperature. The step can continue to include the step of heating the sample to a second temperature in the second segment, where the first temperature is different from the second temperature (see Chen, col. 4, lines 43-55, claim 18).
Chen fails to teach that in response to the temperature reaching the threshold temperature, turning the heater off until the temperature is at or below the target temperature.
However, Gubatayao et al teaches that the heating may be controlled by periodically turning the current on and off to a respective heater with varying pulse width modulation (see Gubatayao et al, [0085]). Gubatayao et al further teaches that while heating may be accomplished by running current through a microfluidic or electronic circuit, cooling may be “passive” in that only convection between the microfluidic chamber and is used to reduce the chamber's temperature (see Gubatayao et al, [0102]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature control system of Chen to incorporate turning the current of the heating element on and off and passive cooling (as taught by Gubatayao et al), for the benefit of managing a plurality of thermal cycling profiles in conjunction with directing a sensor array across each of a plurality of reaction chambers, for performing simultaneous nucleic acid amplification and detection in automating the patient diagnostic assaying process (see Gubatayao et al, Abstract, [0004]).
Regarding claim 14, Chen teaches one or more temperature sensors, coupled to the temperature control system 152, can be positioned proximate the processing stations 150A-150C to monitor the temperature of the stations (see Chen, Fig. 7, col 16, lines 14-26). Each of the processing stations 150A-150C can be maintained at a pre-selected temperature range controlled by a temperature control system 152 and a CPU 174 (see Chen, Fig. 7, col. 15, lines 1-18). Chen additionally teaches a first heater translatable between a first orientation in which the first heater affects the temperature of the reaction mixture and a second orientation in which the first heater does not substantially affect the temperature of the reaction mixture (see Chen, claim 1).
Chen fails to teach turning the heater off.
However, Gubatayao et al teaches that the heating may be controlled by periodically turning the current on and off to a respective heater with varying pulse width modulation (see Gubatayao et al, [0085]). Gubatayao et al further teaches that while heating may be accomplished by running current through a microfluidic or electronic circuit, cooling may be “passive” in that only convection between the microfluidic chamber and is used to reduce the chamber's temperature (see Gubatayao et al, [0102]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature control system of Chen to incorporate turning the current of the heating element on and off and passive cooling (as taught by Gubatayao et al), for the benefit of managing a plurality of thermal cycling profiles in conjunction with directing a sensor array across each of a plurality of reaction chambers, for performing simultaneous nucleic acid amplification and detection in automating the patient diagnostic assay process (see Gubatayao et al, Abstract, [0004]).
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Chen, in view of Fritchie et al (WO 2018119227 A1, as cited in the IDS).
Regarding claim 4, Chen teaches a driver coupled to the compression member to selectively move the compression member and thereby compress the sample vessel within the opening. The driver can be, for example, a motor coupled to the compression member by a cam. Alternatively, the driver can be an electromagnetic actuating mechanism (see Chen, col. 3, lines 15-21). The energy transfer element 48 is embedded in or otherwise coupled to the compression member 22 (see Chen, col 11, lines 38-62, Fig 3).
Chen fails to teach wherein the mechanical device comprises (i) a robotic arm or (ii) an arm and a servomotor.
However, in the analogous art of methods of controlling inductive heating systems to reduce biological carryover, Fritchie et al teaches that a work piece 214 is moved relative to the induction heater 212 via, for example, a robotic arm 221 of the diagnostic instrument 202 so as to selectively heat and clean the first portion 217 and the second portion 219 of the work piece 214 (see Fritchie et al, [0042], Fig 2.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the driver coupled to the compression member and the embedded energy transfer element of Chen to incorporate a robotic arm (as taught by Fritchie et al), for the benefit of being able to reuse aspiration and dispensing devices in reducing waste and operational costs by reducing biological carryover and/or contamination into subsequent tests (see Fritchie et al, [0003]).
Regarding claim 15, Chen teaches one or more temperature sensors, coupled to the temperature control system 152, can be positioned proximate the processing stations 150A-150C to monitor the temperature of the stations (see Chen, Fig. 7, col 16, lines 14-26). Each of the processing stations 150A-150C can be maintained at a pre-selected temperature range controlled by a temperature control system 152 and a CPU 174 (see Chen, Fig. 7, col. 15, lines 1-18).
Chen fails to teach in response to the temperature reaching or exceeding the threshold temperature for a given time period: controlling a notification device to provide a notification of a fault.
However, Fritchie et al teaches an induction heater controller 226, which receives data from power drive unit 220 with respect to, for example, performance of the induction heater 212. the power drive unit 220 communicates data such as a status 236 of the induction heater 212, monitors data with respect to a current and/or a voltage at the induction heater 212, etc. Based on the data received from the power drive unit 220, the induction heater controller 226 can communicate, for example, a present/ready status signal 240 of the induction heater control station 210, a pass/fail status signal 242 with respect to a performance state of one or more components of the induction heater control station 210 such as the power drive unit 220 and/or the induction heater 212 can be used to control the induction heater control station 210 via the diagnostic instrument 202 (see Fritchie et al, Fig 2., [0049]). Fritchie et al further teaches a failure monitor 344, which updates the present/ready status signal 240 and/or the pass/fail status signal 242, and can determine if one or more components of the induction heater control station 210 are malfunctioning and/or failing (see Fritchie et al, Fig. 2-3, [0079], [0080]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control systems of Chen to utilize data received in determining the status of the system whether it is present/ready and pass/fail (as taught by Fritchie et al), for the benefit of being able to predict future failures of components based on data trends recorded by the failure monitor 344, as well as provide failure instructions 346 to the components to address the potential failures (see Fritchie et al, Fig. 3, [0079]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art of Karnieli et al. (US PG-Pub 20150125138 A1), teaches a system for heating a sample in a vessel, where the system includes a heating device configured to transmit energy to the vessel and a base moveable coupled to the heating device. The system can also include a processor configured to receive an input associated with a target temperature, and transmit a signal to controllably move the heating device relative to the base for a time period, wherein the time period is determined based on the target temperature and content volume. (see Karnieli et al., Abstract).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tracy C Colena whose telephone number is (571)272-1625. The examiner can normally be reached Mon-Thus 8:00am-5:00pm.
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, Lyle Alexander can be reached at (571) 272-1254. 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.
/TRACY CHING-TIAN COLENA/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
Prosecution Insights