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 18 March 2026 have been fully considered but they are not persuasive. In response to the Applicant's amendments, the grounds of rejection for claims 21 – 23, 25 – 29, 31, and 41 – 44 are modified compared to the previous action due to the amendments but rely on the same prior art.
With regards to claim 21 and 41, the amendments to the claim rely upon strictly functional language. The language of “the processor to place” or “the processor to set” does not have the same patentable weight as limitations reciting “a processor configured to…”, for instance. The recitation of “to place” or “to set” describes the intended use of the device, but does not strictly imply a structure or function; please see MPEP 2114 for further details on computer implement functional claim limitations. In the interest of advancing prosecution on this case, every attempt has been made to ensure these functional limitations are addressed in the prior art of record.
With regards to the new amended limitation of “a default timing value,” this is not supported in the instant specification. A new rejection is brought forward in light of 112(a), discussed in details below.
Status of Claims
Applicant's amendments to the claims filed 18 March 2026 have been entered. Applicant's remarks filed 18 March 2026 are acknowledged.
Claims 21 and 41 are in status “Currently amended.” Claims 22, 23, 25 – 29, 31, and 42 – 44 are in status “Previously presented.” Claims 32, 33, and 35 – 40 are withdrawn as directed to non-elected subject matter. Claims 1 – 20, 24, 30, 34, 45, and 46 are canceled.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
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 21 and 41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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 inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21 and 41 both recite the limitation “the timing value comprises […] a default timing value when the programmed timing value is not set during the programming mode.” There is not support for these embodiments in the claim. The specification does not describe a default timing value. The specification regularly discusses a “preset” time, such as in [0040], but there’s no details suggesting that a preset time is selected as a default. [0040] and [0050] describe only a user manually selecting a preset time.
The applicant does not include any comments in the Remarks, filed 18 March 2026, establishing support for this limitation in claims 21 and 41. Given this, the lack of description in the specification, and the specification’s teaching away from the claimed embodiment, claims 21 and 41 are rejected under 35 U.S.C. 112(a) as related to new matter unsupported by the specification.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21 – 23, 25 – 29, 31, and 41 – 44 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tycon (US 20220055036 A1, effectively filed 19 August 2020).
With regards to claim 21, Tycon teaches;
The claimed “a medical testing system” has been read on the taught ([0002], “The present disclosure relates in general to batch processing trays of assay cartridges. Assay cartridges are widely used for point of care (POC) testing and laboratory testing.”; The batch processing of cartridges for laboratory testing reads on a medical testing system.);
The claimed “a timer tray comprising a plurality of cassette holders, each of the plurality of cassette holders configured for receiving a cassette including medical material for testing” has been read on the taught ([0029], “The batch processing tray 250 as illustrated has a base 201, a raised back panel 202 and multiple lanes 210, each lane configured to receive a cartridge 100.”; Batch processing tray 250 reads on a timer tray. Multiple lanes 210 reads on a plurality of cassette holders. The lanes configured for receiving a cassette including medical material for testing reads on the cassette holders being configured for receiving a cassette.);
The claimed “a programming switch on the timer tray, the programming switch communicating with the processor to place the plurality of cassette holders in a programming mode when the programming switch is activated” and “the processor to set a timing value for one or more of the plurality of timers, wherein the timing value comprises one of a programmed timing value set by a user using controls on the medical testing system during the programming mode” have been read on the taught ([0034], “The timer can be programmed manually by the operator…”; [0037], “The interface can be a touch screen, or have dials or buttons or any other type of switch to interface with the user.”; A switch to interface with an operator reads on a programming switch. The timer being manually programmed by the operator reads on a programming mode.);
The claimed “a processor […] the processor programmed to receive input indicating activation of a first timer activation switch of the plurality of timer activation switches and further programmed to trigger, as soon as the input is received, a first timer of the plurality of timers for timing processing of the medical material of a cassette in a cassette holder associated with the first timer activation switch” has been read on the taught ([0040], “The controller 400 includes the batch processing tray processor unit 410. Inputs 420 into the batch processor unit include, but are not limited to: […] 2) the activation of the cartridge switch when the cartridge is inserted into the cartridge lane…”; [0034], “Insertion of a cartridge into one of the plurality of cartridge lanes depresses the switch (i.e., mechanical, optical), automatically starting a countdown timer 220…”; Processor unit 410 reads on a processor programmed to receive input. Automatically starting a countdown timer reads on the processor being programmed to trigger a timer as soon as the input is received.);
The claimed “a display to output an indicator when the first timer is expired, based on the timing value of the first timer, indicating that an incubation is complete, such that each timer is separately started by activation of the associated switch” has been read on the taught ([0033], “The timer 220 includes a timer display that displays the time that has elapsed (the timer can also be a countdown timer which shows the time remaining).”).
With regards to claim 22, the system of claim 21 is anticipated by Tycon.
Tycon additionally teaches;
The claimed system “further comprising a display for outputting a state of the first timer” has been read on the taught ([0033], “The batch processing tray 250 has a status light 230 that indicates when development is complete (i.e., changing color from red to green). The status lights 230 are for each lane 210.”; The status lights read on a display for outputting a state of the first timer.);
With regards to claim 23, the system of claim 22 is anticipated by Tycon.
The claimed “wherein the display comprises a multi-color light, and each of a plurality of states of the timer corresponds to a different color of the multi-color light” has been read on the taught ([0033], “The batch processing tray 250 has a status light 230 that indicates when development is complete (i.e., changing color from red to green). The status lights 230 are for each lane 210.”; The display changing color reads on a multi-color light. The status light indicating that development is complete reads on the correspondence between the states of the timer and the color of the light.).
With regards to claim 25, the system of claim 22 is anticipated by Tycon.
The claimed “wherein the state of the first timer indicates a status of the processing, the status including active processing, processing complete and medical material ready, processing complete and medical material expired” has been read on the taught ([0013], “The batch processing tray automatically times the development of an assay cartridge... The batch processing tray may then indicate when development is complete, including an indication of additional time that has elapsed beyond the allotted development time…”; “Development” reads on active processing, “Development complete” reads on processing complete and medical material ready, and the “additional time that has elapsed beyond the allotted development time” reads on processing complete and medical material expired).
The claim language of “wherein the state of the first timer indicates a status of processing, the status including…” is functional language describing the intended use of the device. Please see MPEP 2114(II), and Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Accordingly, this limitation has been given the appropriate patentable weight.
With regards to claim 26, the system of claim 21 is anticipated by Tycon.
The claimed “wherein the medical material is on a test strip, and the processing comprises incubation of the medical material, prior to reading a result of a test” has been read on the taught ([0017], “Once the batch processing tray has determined that the incubation of the assay cartridge is complete […] the cartridge can be moved from the batch processing tray to a cartridge reader.”; An assay cartridge reads on a test strip. The incubation reads on the processing comprising incubation of the medical material. The incubation occurring before the cartridge is moved to a cartridge reader reads on the processing occurring prior to reading a result of a test).
The claim language of “the processing comprises incubation of the medical material, prior to reading a result of a test” is functional language describing the intended use of the device. Please see MPEP 2114(II), and Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Accordingly, this limitation has been given the appropriate patentable weight.
With regards to claim 27, the system of claim 21 is anticipated by Tycon.
The claimed “wherein the switch is automatically activated when the cassette is placed in the cassette holder” has been read on the taught ([0033], “Once seated in a lane, a switch 231 is activated. […] This also activates a timer 220 to automatically time the development of an assay cartridge upon the placement of a cartridge into the tray.”).
With regards to claim 28, the system of claim 26 is anticipated by Tycon.
The claimed “wherein the switch is deactivated when the cassette is removed from the cassette holder” has been read on the taught ([0046], “Once the user removes the cartridge, processing for that lane terminates.”; [0030] and [0031] teach the use of mechanical or optical switches, which detect both presence and absence of a cartridge.).
With regards to claim 29, the system of claim 21 is anticipated by Tycon.
The claimed “wherein the timer is one of a countdown timer or a count-up timer” has been read on the taught ([0033], “The timer 220 includes a timer display that displays the time that has elapsed (the timer can also be a countdown timer which shows the time remaining).”).
With regards to claim 31, the system of claim 21 is anticipated by Tycon.
The claimed system further comprising “the processor to trigger a second timer when the first time is expired, the second timer to determine when the medical material is expired and can no longer be read” has been read on the taught ([0014], “The batch processing tray indicates to the operator when the timed steps are complete, including an indication of time elapsed after the prescribed duration of assay cartridge development (flex-time), to prevent excessive assay development.”; The indication of time elapsed reads on the triggering of a second timer.).
The claim language of “the second timer to determine when the medical material is expired and can no longer be read” is functional language describing the intended use of the device. Please see MPEP 2114(II), and Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Accordingly, this limitation has been given the appropriate patentable weight.
With regards to claim 41, Tycon teaches;
The claimed “a medical testing system” has been read on the taught ([0002], “The present disclosure relates in general to batch processing trays of assay cartridges. Assay cartridges are widely used for point of care (POC) testing and laboratory testing.”; The batch processing of cartridges for laboratory testing reads on a medical testing system.);
The claimed “a plurality of cassette holders, each cassette holder designed to receive a cassette including medical material for testing” has been read on the taught ([0029], “The batch processing tray 250 as illustrated has […] multiple lanes 210, each lane configured to receive a cartridge 100.”; Multiple lanes 210 reads on a plurality of cassette holders. The lanes configured for receiving a cassette including medical material for testing reads on the cassette holders being configured for receiving a cassette.);
The claimed “a plurality of activation switches, each activation switch indicating that a cassette has been inserted into an associated one of the plurality of cassette holders” has been read on the taught ([0033], “Once seated in a lane, a switch 231 is activated. This registers the placement of a cartridge in a particular lane.”);
The claimed “a plurality of timers, each for timing a processing of the medical material in a cassette in an associated cassette holder” has been read on the taught ([0033], “This also activates a timer 220 to automatically time the development of an assay cartridge upon the placement of a cartridge into the tray.”);
The claimed “a programming switch on the timer tray, the programming switch communicating with the processor to place the plurality of cassette holders in a programming mode when the programming switch is activated” and “the processor to set a timing value for one or more of the plurality of timers, wherein the timing value comprises one of a programmed timing value set by a user using controls on the medical testing system during the programming mode” have been read on the taught ([0034], “The timer can be programmed manually by the operator…”; [0037], “The interface can be a touch screen, or have dials or buttons or any other type of switch to interface with the user.”; A switch to interface with an operator reads on a programming switch. The timer being manually programmed by the operator reads on a programming mode.);
The claimed “a processor […] the processor programmed to receive an input indicating that the processing has started in one or more of the plurality of cassette holders by activation of the respective one or more plurality of switches of the one or more cassette holders, and further programmed to trigger one or more of the plurality of timers the as soon as the input has been received, one or more associated timers of timing the processing of the medical material of the associated cassette holders” has been read on the taught ([0040], “The controller 400 includes the batch processing tray processor unit 410. Inputs 420 into the batch processor unit include, but are not limited to: […] 2) the activation of the cartridge switch when the cartridge is inserted into the cartridge lane…”; [0034], “Insertion of a cartridge into one of the plurality of cartridge lanes depresses the switch (i.e., mechanical, optical), automatically starting a countdown timer 220…”; Processor unit 410 reads on a processor programmed to receive an input. Automatically starting a countdown timer reads on the processor being programmed to trigger a timer as soon as the input is received.).
With regards to claim 42, the system of claim 41 is anticipated by Tycon.
The claimed “wherein the processing comprises an incubation time and a readability period prior to an expiration of the medical material” has been read on the taught ([0013], “The batch processing tray automatically times the development of an assay cartridge... The batch processing tray may then indicate when development is complete, including an indication of additional time that has elapsed beyond the allotted development time…”; Timing the development of an assay cartridge reads on an incubation time. The additional time that has elapsed beyond the allotted development time reads on a readability period.).
The claim language of “wherein the processing comprises an incubation time and a readability period prior to an expiration of the medical material” is functional language describing the intended use of the device. Please see MPEP 2114(II), and Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Accordingly, this limitation has been given the appropriate patentable weight.
With regards to claim 43, the system of claim 42 is anticipated by Tycon.
The claimed “wherein a second timer period to indicate the readability period is automatically started after an expiration of a first timer period for the incubation time” has been read on the taught ([0014], “The batch processing tray indicates to the operator when the timed steps are complete, including an indication of time elapsed after the prescribed duration of assay cartridge development (flex-time), to prevent excessive assay development.”; The indication of time elapsed reads on the second timer being automatically started.).
With regards to claim 44, the system of claim 41 is anticipated by Tycon.
The claimed “a plurality of timer displays, each timer display associated with one of the plurality of cassette holders to indicate a status of the medical material, wherein the timer display indicates that the medical material status is: incubating, ready for reading, or expired” has been read on the taught ([0036], “In the illustrated embodiment each lane 210 is provided with a status light 230. […] In one example the status light could be on constantly during development/incubation, blinking during flex-time, and off when the flex-time has been exceeded.”; Incubation reads on “incubating”, flex-time reads on “ready for reading”, and flex-time has been exceeded reads on “expired.”);
The claim language of “wherein the timer display indicates that the medical material status is: incubating, ready for reading, or expired” is functional language describing the intended use of the device. Please see MPEP 2114(II), and Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Accordingly, this limitation has been given the appropriate patentable weight.
Conclusion
THIS ACTION IS MADE FINAL. 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 ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST.
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.
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/ALISON CLAIRE GERHARD/Examiner, Art Unit 1797
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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