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 .
Claim Rejections - 35 USC § 103
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, 2, 6, 7, 14-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US20060263258) in view of Pederson et al. (WO201261228).
Regarding Claim 1, Harris teaches the following:
An automated incubator with a self-contained biological indicator which detects a change in the biological indicator color media through the measurement of light intensity as it is passed through the indicator which provides an indication of the outcome of the sterilization process (a sterilization indicator reading apparatus)(para 19).
A housing with a top portion, bottom portion, and a major side portion (see annotated Fig. 2 below)
A well formed from a portion of the housing accessible from the top portion oriented along the well axis from the top to bottom portion (Fig. 2, below) and the incubation test wells 24 are for holding biological indicator vials 26 (the well dimensioned to receive at least a portion of a sterilization indicator)(para 20) and the indicator vial 26 positioned in the test well 24 has a spore strip 62 and media 63 (indicator having spores)(para 23). The color change of the biological indicator colored media is detected through the measurement of the light intensity passed through it (substance fluorescently responsive to spore concentration and the spores responsive to the environmental condition in the indicator)(para 23).
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The incubator is programmable to operate at different temperature setting by controlling the temperature of heater block 48 positioned at incubation test well 24 (a heating element thermally coupled to a portion of the well) (para 22)
PC (printed circuit) boards 56,58 (sterilization indicator activation circuit for detecting activation of the sterilization indicator, wherein the excitation source is positioned such that the light from the excitation source is directed into the well)(para 24 and see Fig. 3, annotated below)
A photodetector 54 (color sensor) opposite the LED 52 (excitation source) on the other side of the vial to read the light level (a color sensor positioned adjacent the well, wherein the color sensor is positioned to receive light from the sterilization indicator)
Incubator includes a control system 100 having communication devices (processor and memory) which communicates with the optical detection system (excitation sources,
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and color sensor), temperature control system (heating element), and user interfaces (para 26)
Harris further teaches an optical detection system which includes a point light source (e.g., an LED)(para 23).
Harris does not teach an ultraviolet light excitation source to excite the substance in the sterilization indicator.
Pederson teaches a biological sterilization indicator and a reading apparatus comprising a well (Abstract). Pederson further teaches the detection process for verifying the efficacy of a sterilization process can employ fluorescence detection (page 46, lines 25-27). Pederson further teaches the sensor adapted for fluorescence detection includes at least one emitter or excitation source (e.g., an LED) and the LEDs can be UV LEDs (para 180)(page 46, lines 28-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the optical detection system of Harris with the UV LED fluorescence excitation source as taught by Pederson. One would have been motivated to make this modification as Pederson teaches the detection process can be adapted to detect a variety of characteristics including electromagnetic radiation (e.g., in the ultraviolet, visible, and/or infrared bands), fluorescence, luminescence, or light scattering (page 32, lines 26-30).
Regarding Claim 2, Harris in view of Pederson teaches all of the limitations of Claim 1 (see above). Harris further teaches the LED (excitation source), photodetector (color sensor), are mounted to the PC (printed circuit) boards 56,58 (first printed circuit board having the excitation source, color sensor, disposed thereon) and the first circuit board from a first plane that is parallel with the well axis (see Fig. 3, above). The controller circuit is also mounted to the first PC board as seen in Fig. 2, above).
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Regarding Claim 6, Harris in view of Pederson teach all of the limitations of Claim 2 (see above). Harris further teaches a second printed circuit board which has a visual control display (28)(para 20) thereon and the second printed circuit board is parallel to the first printed circuit board (see Fig. 2 below).
Regarding Claim 7, Harris in view of Pederson teach all of the limitations of Claim 1 (see above). Harris further teaches the control system configured so each channel turns the LED on for a period of time and the resulting signal is used to verify that a tube is present as well as determine if a color change has occurred (para 27)(the memory comprises instructions which causes the processor to determine whether the sterilization indicator is activated based on a medium color of the sterilization indicator).
Regarding Claim 14, Harris in view of Pederson teach all of the limitations of Claim 1 (see above). Harris further teaches the incubator can operate at different temperatures by controlling the temperature of the heater block 48 (para 22, Fig. 4 below)(a heater block forming a portion of the well, wherein the heating element is thermally coupled to the heater block).
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Regarding Claim 15, Harris in view of Pederson teach all of the limitations of Claim 6 (see above). Harris further teaches on the face of the incubator is an LED 36, that provides a visual correspondence to system operations, outputs, and alarms (para 42) and if the incubator is unable to maintain a select temperature, the LED will flash red (para 63). This means the LED taught by Harris is an indicator of temperature controls.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have an LED indicating a heating element is active and a second LED indicating a temperature being achieved, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art (MPEP § 2144.04 (VI)(B)).
Regarding Claim 16, Harris in view of Pederson teach all of the limitations of Claim 15 (see above). Harris further teaches the automated incubator is programmable to operate at different temperature settings by controlling the temperature heater block (para 22) (the memory comprises instructions that when executed by the processor, causes the heating element to achieve a preset temperature during an incubation cycle).
Regarding Claim 17, Harris in view of Pederson teach all of the limitations of Claim 1 (see above). Harris further teaches the automated incubator, which includes the control system which communicates with internal and external devices, has the ability to receive inputs, generate outputs, and send and receive queries, etc. (para 26), utilizes the optical detection system to detect a color change in the biological indicator through the measurement of light intensity passed through the indicator (para 23) (the memory comprises instructions that when executed by the processor, causes the processor to activate a fluorescence detection cycle to determine sterilization efficacy of the sterilization indicator based on a response to the fluorescence excitation source).
Regarding Claim 18, Harris in view of Pederson teach all of the limitations of Claim 17 (see above). Harris further teaches the control system is configured to activate each light source within a desired time period (claim 31) (activating the fluorescence excitation source for a time period), the automated control system receives a signal which is used to verify if a color change has occurred and if that color change is appropriate (para 27)(receive a reading from the color sensor corresponding to a plurality of color channels, determine a fluorescence reading from the plurality of color channels at the time period), and the control system is configured to receive the output signal and determine a sterility characteristic of a biological indicator using the output signal (claim 1) (acquire a plurality of fluorescence readings and determine the sterilization efficacy based on the plurality of fluorescence readings not increasing).
Regarding Claim 20, Harris in view of Pederson teach all of the limitations of Claim 1 (see above). Harris further teaches the automated incubator is suitable for use with a self-contained biological indicator and that one or more well 24 are for holding biological indicator vials 26 (para 19 and 20).
Claims 3-5, 8-10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US20060263258) in view of Pederson et al. (WO201261228) and further in view of Waldo et al. (US20030165398).
Regarding Claim 3, Harris in view of Pederson teach all of the limitations of Claim 1 (see above). Harris further teaches an embodiment where a second LED was added (para 37) but Harris in view of Pederson does not explicitly teach the second LED to be a white LED.
Waldo teaches a system in which biological fluid is introduced into a chamber where it is contacted with light provided by one or more light sources, a light sensing system which senses the intensity of illumination of the light, a circuit board and various other sensors (Abstract). Waldo further teaches the light box may include sensors for detecting different conditions during the pretreatment and treatment processes (para 106).
Waldo further teaches the light box may include one or more light sources (para 90) and the light sources suitable for use in the invention may include white light, red light, infrared light, or ultraviolet light (para 93).
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 second LED of Harris in view of Pederson to be white light . One would have been motivated to make this modification as Waldo teaches the light to include any light source that is capable of providing light of a particular wavelength and intensity needed (para 93).
Regarding Claim 4, Harris in view of Pederson and further in view of Waldo teach all of the limitations of Claim 3 (see above). Harris further teaches the LED (excitation sources), photodetector (color sensor), are mounted to the PC (printed circuit) boards 56,58 (first printed circuit board having the excitation source, color sensor, disposed thereon) and the first circuit board from a first plane that is parallel with the well axis (see Fig. 3, above). The controller circuit is also mounted to the first PC board as seen in Fig. 2, above).
Regarding Claim 5, Harris in view of Pederson and further in view of Waldo teaches all of the limitations of Claim 4 (see above). Harris further teaches a plurality of wells wherein the printed circuit board is continuous (see Fig. 2 above) so the excitation source, the white LED (after modification by Waldo), and the color sensor of the first well are on the same printed circuit board as the excitation source, white LED, and color sensor of a second well.
Regarding Claim 8, Harris in view of Pederson teach all of the limitations of Claim 7 (see above). Harris further teaches an embodiment where a second LED was added (para 37) but Harris in view of Pederson does not explicitly teach the second LED to be a white LED.
Waldo further teaches the light box may include one or more light sources (para 90) and the light sources suitable for use in the invention may include white light, red light, infrared light, or ultraviolet light (para 93).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a second white LED to Harris in view of Pederson.
One would have been motivated to make this modification as Waldo teaches the light to include any light source that is capable of providing light of a particular wavelength and intensity needed (para 93).
Regarding Claim 9, Harris in view of Pederson and further in view of Waldo teaches all of the limitations of Claim 8 (see above). Harris further teaches the control system is configured to activate each light source once within a desired time period (claim 31)(white light source for a first time period). Harris further teaches the control system to check each test well for BI vial presence (para 32)(receive a first reading from the color sensor corresponding to a first plurality of color channels and to determine presence of the sterilization indicator).
Regarding Claim 10, Harris in view of Pederson and further in view of Waldo teaches all of the limitations of Claim 9 (see above). As above, Harris teaches there is a signal which is used to verify that a tube is present as well as determine if a color change has occurred (para 27). This means the processor is determining the status of the sterilization indicator based on some form of color channels even though it is not explicitly disclosed.
Regarding Claim 13, Harris in view of Pederson teach all of the limitations of Claim 1 (see above). Harris in view of Pederson do not teach a long pass filter disposed on the color sensor.
Waldo teaches the sensors may include or be used with one or more filters (para 108).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a filter to the sensor of Harris in view of Pederson as taught by Waldo. One would have been motivated to make this addition as it would filter out unwanted light (para 108).
Response to Arguments
Applicant's arguments filed 12/07/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments on page 9 that Harris does not teach a color sensors. Harris teaches an optical detection system 50 to detect a color change (dark to light color change) which includes the photo-detector 54 to read the light level (para 23-24). Further, the claim does not exclude the color sensing to be a change in intensity of color.
In response to applicant's argument that the combination of Harris and Pederson is flawed from a mechanical perspective, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Pederson teaches a sensor adapted for fluorescence detection includes at least one emitter or excitation source (e.g., an LED) and the LEDs can be UV LEDs (para 180)(page 46, lines 28-30). One of ordinary skill in the art would be able to incorporate this teaching into the device of Harris.
The amendments to address the 112(b) Rejections from the 10/02/2025 Office Action have been accepted and the 112(b) Rejections from the 10/02/2025 Office Action have been withdrawn.
Allowable Subject Matter
Claims 11, 12 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claims 11 and 12, Harris in view of Pederson and further in view of Waldo teaches all of the limitations of Claims 10 (see above).
Neither Harris, Pederson or Waldo teach a memory comprising instructions that when executed by the processor, causes the processor to deactivate the white LED in response to the sterilization indicator being activated.
Further, examiners search provided no other prior art which anticipates or would have been obvious to combine to arrive at the claimed invention.
Regarding Claim 19, Harris in view of Pederson and further in view of Waldo teaches all of the limitations of Claims 8 (see above).
Neither Harris, Pederson or Waldo teach a memory comprising instructions that when read by the processor, causes the controller circuit to activate the white LED of the sterilization indicator activation detection circuit for a first time period having a first duration, and activate the excitation source for a second time period having a second duration, wherein the first duration is less than a second duration of the second time period.
Further, examiners search provided no other prior art which anticipates or would have been obvious to combine to arrive at the claimed invention.
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 JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at 571-272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.E.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796
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