DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 2, 14, 40, 47, 67, and 79 in the reply filed on 12 February 2026 is acknowledged.
Claims 106, 109, and 110 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12 February 2026.
Response to Amendment
This is an office action in response to Applicant’s arguments filed on 12 February 2026. Claims 1, 2, 14, 40, 47, 67, 79, 106, 109, 110, and 135-137 are currently pending. Claims 106, 109, and 110 are withdrawn. Claims 3-13, 15-39, 41-46, 48-66, 68-78, 80-105, and 111-134 are cancelled. Claims 135-137 are newly added.
Claims 1, 2, 14, 40, 47, 67, 79, and 135-137 are being examined herein
Status of Objections and Rejections
The objection to the drawings are withdrawn in view of amendments.
The objections to claims 40 and 47 are withdrawn in view of amendments.
The rejection of claims 1, 2, 14, 40, 47, and 79 under USC § 112(b) are withdrawn in view of amendments.
The rejection of claim 67 under USC § 112(b) is maintained.
The rejection of claims 1, 2, 14, 40, 47, 67 and 79 under USC § 102(a)(1) in view of Cho (US 20160369222 A1) are withdrawn in view of amendments.
Response to Arguments
Applicant’s arguments, see Remarks pages 21-22, filed 12 February 2025, with respect to the rejection(s) of claim(s) under USC § 102(a)(1) in view of Cho (US 20160369222 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Cho (US 20160369222 A1) in view of Tipgunlakant, et. al. (US 20180291417 A1).
Applicant argues newly amended claim 1 is no longer anticipated by Cho. Specifically, Cho does not teach, disclose, or suggest “the sample temperature control element forms a controlled temperature zone having a volume less than 10% a volume of the housing in which the sample carrier is disposed and in which a controlled temperature substantially different from an ambient temperature is maintained…” (Remarks, pg. 21, par. 07), to which examiner agrees.
Cho, however, does teach, disclose, or suggest several other elements of the device and therefore is still be used as prior art in the rejections as detailed below.
Applicant offers no further argument for dependent claims aside from their dependence on claim 1 (Remarks, pg. 22, par. 02-03).
Claim Interpretation
Examiner notes, "ambient temperature" as defined by applicant on 19, lines 27-32 of the specification of the instant application, is "the air temperature of the environment or immediate surroundings" and can be, "in certain embodiments, ambient temperature may be between 1 °C and 60 °C." For purposes of examination, Examiner will interpret a maximum ambient temperature of 37°C corresponding with the human body temperature.
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 67 and 136 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 67 still uses exemplary language that contribute to indefiniteness. Below is a non-extensive list of such claim language that imparts indefiniteness to the claim.
“e.g., each well”
“ e.g., analyte”
“e.g., photoluminescence sensors”
“e.g., generates a signal proportional to oxygen consumption rate (OCR) of the sample”
“e.g., generates a signal proportional to extracellular acidification rate (ECAR) and/or proton efflux rate (PER) of the sample”
“e.g., impedance”
The use of exemplary language leads to potential confusion in the scope of the claim. Examiner recommends removing exemplary language from the claim set in order to establish a clear scope for each element in the claim. For purposes of examination, examiner will not use the examples listed in claims to limit the interpretation of the claim.
Claim 136, recites the limitation “the controlled temperature is between 12 degrees Celsius or and 1 degree Celsius” in lines 1-2 of the claim. Examiner believes this should be interpreted to be “between 1 degree Celsius and 12 degrees Celsius” based on page 36, lines 23-31 of the specification of the instant application, and will be examined as such.
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.
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, 2, 40, 67, and 135-137 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (US 20160369222 A1) in view of Tipgunlakant, et. al. (US 20180291417 A1).
Regarding claim 1, Cho teaches an apparatus for measuring cell metabolism on a microplate (Abstract). Cho teaches the metabolism measuring apparatus comprises:
a housing 10 surrounding the equipment and parts (Fig. 1; par. 0032) (a housing)
a sensor housing 20 comprising a sensor board 500 with an array of sensors that correspond to a microplate array that is directly below a microplate 300 all within housing 10 (Fig. 2-3; par. 0038) (a sensing system disposed within the housing and comprising an array of sensor units)
the microplate 300 comprises an array of wells and each well 310 of the microplate aligns with a light emitting 521, 522 and light detecting 511, 512 elements (that measure dissolved oxygen (DO) and pH respectively) (Fig. 3-4; par. 0038, 0040) (an array of sensor units configured to generate a first signal in response to a first analyte and a second signal in response to a second analyte, wherein each sensor unit of the array of sensor units is positioned to correspond with a corresponding well on a sample carrier comprising an array of wells)
a stage table 400 that holds microplate 300 on top (Fig. 2-4; par. 0037) (a stage configured to receive the sample carrier)
stage table 400 further comprises a X-Y driving assembly that moves the stage 400 and microplate 300 along an x- and y-axis (Fig. 2; par. 0037) (a motion actuator assembly configured to position the stage and the sensing system relative to one another on one or more axes within the housing)
a controller 700 that controls/drives all aspects of the apparatus including controlling the optical measurement and analyzing the electrical signal from the DO and pH sensors through signal processor 530 on sensor board 500 (Fig. 5; par. 0039, 0044-0045) (a signal processing module operatively connected to the sensing system)
As seen in Figure 1 and 2, only a small portion of the overall device is made up of the microplate 300 (a volume less than 10% a volume of the housing in which the sample carrier is disposed), with the remaining space being occupied by other elements or serving at empty space above the microplate 300 (Fig. 1) (a headspace of the housing). Cho teaches a precise temperature control function for the interior of the housing, including the empty space, at a predetermined temperature, such a human body temperature of 37 °C (par. 0061) (a headspace of the housing, comprising a remainder of the volume of the housing not included in the controlled temperature zone, is maintained at a temperature substantially equal to the ambient temperature while the controlled temperature is maintained in the controlled temperature zone).
Cho is silent to the sample temperature control element being configured to control a first temperature of a first sample within a first well of the array of wells to be within a predetermined range of a second temperature of a second sample within a second well of the array of wells; and wherein the sample temperature control element forms a controlled temperature zone having a volume less than 10% a volume of the housing in which the sample carrier is disposed and in which a controlled temperature substantially different from an ambient temperature is maintained
Tipgunlakant teaches a cell culture incubating device for cells within a microplate with a plurality of sensors (Abstract). Tipgunlakant teaches the device partially comprises a microplate 500 with an array of wells 510; the microplate receivable within an incubator system 300 that is configured to regulate temperature through thermal regulator 570 (Fig. 5; pg. 0135-0136) (a sample temperature control element). Tipgunlakant teaches an embodiment wherein each microplate is its own controlled environment (par. 0139) because different cell types have different requirements for culturing, one requirement being temperature (par. 0178). Tipgunlakant teaches temperature control for the microplate can come down to individual well wall temperature through controlled thermoelectric devices (par. 0196-0198) meaning one well can be a temperature different from an adjacent well (a sample temperature control element configured to control a first temperature of a first sample within a first well of the array of wells to be within a predetermined range of a second temperature of a second sample within a second well of the array of wells). Tipgunlakant teaches the individual control of each well, in regard to temperature plus a plurality of other factors, allows for a wide variety of environmental factors to be tested on multiple cell types without disrupting the overall cell incubation environment for improved accuracy (par. 0005-0007).
It would have obvious for one of ordinary skill in the art before the effective filing date of the invention to combine the precise temperature control function for the entire housing of Cho with the temperature control elements for individual wells as taught by Tipgunlakant. One would be motivated to make the combination because it would allow for analysis of multiple cell types under multiple conditions without interrupting the overall incubation environment resulting in improved accuracy (Tipgunlakant par. 0005-0007), and this simple combination over and overall device thermal regulation (Cho) with individual well thermal regulation (Tipgunlakant) would obtain predictable results. MPEP 2143(I)(A).
Further, it would have obvious for one of ordinary skill in the art before the effective filing date of the invention to combine the precise temperature control function for the entire housing of Cho with the temperature control elements for individual wells as taught by Tipgunlakant because doing so would allow for multiple conditions or cell types to be analyzed simultaneously ultimately decreasing overall analysis time with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 2, modified Cho teaches sensor housing 20, stage table 400, X-Y driving assembly that moves the stage 400, microplate 300, and controller 700 (as seen partially by computing device 30 in Cho, Fig. 1 and detailed in Cho par. 0050), and sensor board 500 with signal processor 530 (Cho, par. 0045) are all disposed within the housing 10 (Cho, Fig. 1-2). As seen above in claim 1, sampler temperature control elements will be disposed in the walls of individual sample wells of the microplate 300 and by association will also be disposed in housing 10 of Cho (wherein the sensing system, the stage, the motion actuator assembly, the sample temperature control element, and the signal processing module are contained within the housing). Cho additionally teaches a front cover 11 on a sidewall that opens and closes to gain access to the inside of the housing 10 to deposit microplates 300 (Cho, Fig. 1; par. 0032) (wherein the housing comprises an opening on a side wall dimensioned to allow passage of the stage and the sample carrier).
Regarding claim 40, modified Cho teaches the well microplate 300 comprises an array of wells 310 including a plurality of wells along the outside edge of the microplate 300 and in the interior of microplate 300 (Fig. 3) (wherein the first well is a border well and the second well is an internal well of the sample carrier, wherein the border well is a well which has no other well disposed between the border well and an edge or border of the sample carrier, and the internal well is a well which has at least one other well disposed between the internal well and the edge or border of the sample carrier).
Regarding claim 67, Modified Cho additionally teaches:
The sensing board 500 comprises light emitters 521, 522 (like LEDs) and light detectors 511, 512 (like photodiodes) for each well 310 of the microplate 300 (Cho, Fig. 4; par. 0044) (the sensing system comprises one or more optical sensors)
The fluorescence emission detected by light detector is proportional to oxygen concentration (Cho, par. 0047) (the sensing system is configured to generate a signal in response to rate of change of an analyte proportional to O2 content in the sample)
The fluorescence emission detected by light detector is inversely proportional to hydrogen ion concentration (pH) (Cho, par. 0047) (the sensing system is configured to generate a signal in response to rate of change of an analyte proportional to pH value in the sample)
Regarding claim 135, modified Cho in view of Tipgunlakant teaches an ideal maximum of the temperature range to be 47 °C (Tipgunlakant, par. 0178), which is 10°C above the determined ambient temperature of Cho (Cho, par. 0061) (wherein the controlled temperature is at least 8 degrees Celsius above the ambient temperature).
Regarding claim 136, modified Cho in view of Tipgunlakant teaches cells able to survive temperatures down to 10 °C (Tipgunlakant, par. 0178), and while not within the ideal range, wells can be lowered to as low as 10 °C (wherein the controlled temperature is between 12 degrees Celsius or and 1 degree Celsius).
Regarding claim 137, modified Cho teaches a precise temperature control function for the interior of the housing, including the cartridges 100 and respective pumps 200 disposed within housing 10, at a predetermined temperature (Cho, Fig. 1-2; par. 0061) (a manifold temperature control element configured to control a dispensing temperature of the dispensing system). Cho teaches controller 700 controls overall operation of the system including the precise temperature control function for the interior of the housing, including the cartridges 100 and pumps 200, at a predetermined temperature based on sensor feedback, such a human body temperature of 37 °C (Cho, par. 0039, 0061). Modified Cho in view of Tipgunlakant teaches computer controller 320 controls the individual environments of the wells based on sensor feedback (Tipgunlakant, Fig. 3, 5; par. 0121, 0196-0199). Because the temperature of each well can be controlled individually, once of ordinary skill in the art can conclude a computer controller, like that taught by Cho and Tipgunlakant, the precise temperature control function can also be controlled separately (the manifold temperature control element and the sample temperature control element are configured to control temperature independently). Further, Tipgunlakant teaches the typical temperature range for the wells is between 30°C to 47°C (Tipgunlakant, par. 0178). Therefore, if the individuals wells can easily be controlled to be 36°C to 40°C as taught by Tipgunlakant, the precise temperature control function can be maintained at 37°C as taught by Cho (the manifold temperature control element is configured to control an agent temperature of the target agent and a sensing temperature of the sensing system to be within 3 degrees of the first temperature of the first sample).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cho (US 20160369222 A1) in view of Tipgunlakant, et. al. (US 20180291417 A1) as applied to claim 1 above, and further in view of Brennen, et. al. (US 20170328928 A1).
Regarding claim 14, Modified Cho teaches cartridges 100 fluidically connected to infusion pumps 200 wherein the infusion pumps 200 (syringe pumps) are configured to pump a drug solution into the wells 310 (Cho, Fig. 1, 2; par. 0033-0034) (a dispensing system comprising at least one injector configured to dispense at least one target agent into one or more wells of the array of wells).
Modified Cho is silent to an injector motion actuator assembly positioned to drive the at least one injector to dispense the at least one target agent across a plurality of wells of the array of wells.
Brennen teaches a liquid transfer apparatus for transporting liquids to and from an array to a remotely positioned site (Abstract). Brennen teaches the liquid transfer apparatus 300 comprises a liquid transfer device 338 from one location (source 100) to another (destination 200), and to solution stations 340, and a wash stations 342 by staging device 354 (Fig. 3; par. 0058-0059, 0061) (a dispensing system comprising at least one injector configured to dispense at least one target agent into one or more wells of the array of wells). Staging device 354 is an automated three-axis device for actuating movement of a transfer element head 352 in the three dimensions to any one of the above stated locations (Fig. 3; par. 0061) (an injector motion actuator assembly positioned to drive the at least one injector to dispense the at least one target agent across a plurality of wells of the array of wells). Brennen teaches the movement of the transfer element head 352 by staging device 354 allows for the head to move independently of the source and destination to other locations like wash stations between each liquid transferring process in order to prevent cross contamination via carryover (par. 0071).
It would have obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the stationary infusion pumps of Cho to instead be movable by a staging device as taught by Brennen because doing so would allow the injector/transfer head to be moved independently of the array of wells/destination after the transferring process and move to a secondary location to be washed to prevent potential cross contamination as taught by Brennen (Brennen, par. 0071).
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Cho (US 20160369222 A1) in view of Tipgunlakant, et. al. (US 20180291417 A1) as applied to claim 1 above, and further in view of Orozco ("Optimizing Precision Photodiode Sensor Circuit Design" 2014).
Regarding claim 47, modified Cho teaches controller 700 through signal processor 530 on sensor board 500 is capable of shaping the waveform of the amplified signal through a waveform shaper 535 like through the Schmitt trigger which will compare signal voltage to a reference level to standardize the voltage signal (Cho, Fig. 5; par. 0045) (the signal processing module comprises a printed circuit assembly).
Modified Cho is silent to the signal processing module comprises a printed circuit assembly having a transimpedance amplifier including grounded guard traces.
Orozco teaches photodiodes are popular sensor type for optical based-analysis )pg. 1, col. 1, par. 1). Orozco teaches when using photodiode sensors, a transimpedance amplifier is used to convert the photodiode current into an output voltage (pg. 1, col. 1, par. 1); however, these circuit layouts are prone to external leakage that will interfere with the amplifier (pg. 2, col. 1, par. 2). Orozco teaches running a guard trace on the circuit with the amplifier will help prevent external leakage (Fig. 4; pg. 2, col. 1, par. 3).
It would have obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the (circuit) board that includes an amplifier of modified Cho to further include guard traces as taught by Orozco because doing so would prevent external leakage and improve the signal. MPEP 2143(I)(G).
Claim 79 is rejected under 35 U.S.C. 103 as being unpatentable over Cho (US 20160369222 A1) in view of Tipgunlakant, et. al. (US 20180291417 A1) as applied to claim 1 above, and further in view of Baran, et. al. ("Thermal Analysis of the Factors Influencing Junction Temperature of LED Panel Sources", 2019).
Regarding claim 79, modified Cho further teaches the sensor board 500 (printed circuit) comprises light emitters 521, 522 (like LEDs) and light detectors 511, 512 (like photodiodes) for each well 310 of the microplate 300 (Fig. 4; par. 0044) (a light source, configured to excite a sensor unit of the array of sensor units to generate one or more of the first signal and the second signal) (the light source is positioned on a… printed circuit). Cho teaches controller 700 through signal processor 530 on sensor board 500 is capable of shaping the waveform of the amplified signal through a waveform shaper 535 like through the Schmitt trigger which will compare signal voltage to a reference level to standardize the voltage signal (Cho, Fig. 5; par. 0045) (the light source is configured to produce a reference signal, wherein fluctuations in intensity from the light source are corrected proportionally to drift by monitoring the reference signal produced by the light source).
Modified Cho is silent to the sensor board (printed circuit) being a thermally conductive printed circuit assembly configured to minimize drift from the light source, wherein the thermally conductive printed circuit assembly is formed of a material configured to minimize drift generated by heat-induced fluctuations from the light source by at least 20%.
Baran teaches to maintain the lifetime and reliability of light sources such as LEDs, the junction temperature should maintain a low value (Abstract). Baran teaches one way to lower the total thermal resistance of the LED source is including a metal core printed circuit board (MCPCB) on which the electrical components of the LED are printed (Fig. 1; pg. 3, par. 03). Specifically, Baran teaches an array of LEDs with sources installed on the MCPCB (pg. 3, par. 05) (the light source is positioned on a thermally conductive printed circuit assembly configured to minimize drift from the light source, wherein the thermally conductive printed circuit assembly is formed of a material configured to minimize drift generated by heat-induced fluctuations from the light source). Baran teaches decreasing the temperature of the thermal junction through improving heat dissipation improves LED lifetime, maintains the value of the emitted light and the dominant wavelength (pg. 2, par. 01).
It would have obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the (circuit) board of modified Cho to be a thermally conductive printed circuit board as taught by Baran because doing so would improve LED lifetime and maintain emitted light value and wavelength as taught by Baran.
Modified Cho in view of Baran is silent to a material configured to minimize drift generated by heat-induced fluctuations from the light source by at least 20%.
Baran, however, teaches wherein the optical efficiency (and therefore minimization of drift) is a result-effective variable. Specifically, Baran teaches that the optical efficiency is partially determined by the forward current (Table 1), MCPCB material, and MCPCB thickness (Table 2). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to select a current and MCPCB material and thickness that will minimize drift generated by heat-induced fluctuations from the light source by at least 20%.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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