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 3, claims 26, 28, and 31, in the reply filed on 03/20/2026 is acknowledged.
Claims 1, 3-12, 14-16, 18-19, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/20/2026.
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 26, 28, and 31 are 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.
Regarding claim 26, claim 26 recites the limitation "the effectiveness" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 28 and 31 are rejected by virtue of their dependency on claim 26. It is suggested to recite “the effectiveness” as “effectiveness”.
Regarding claim 26, claim 26 recites “a sterilization process” in lines 3 and 4. It is unclear if the sterilization process of lines 3 and/or 4 is the same or different from the “sterilization process” established in lines 1-2. Additionally, claim 26 refers to “the sterilization process” throughout the claim and it is unclear which “sterilization process” is being referred to (i.e. lines 1-2, 3, or 4). It is suggested to recite “a sterilization process” as “the sterilization process” if referring to the same sterilization process established in lines 1-2. Claims 28 and 31 are rejected by virtue of their dependency on claim 26.
Regarding claim 26, claim 26 recites the limitation "the detection" in line 8. There is insufficient antecedent basis for this limitation in the claim. Claims 28 and 31 are rejected by virtue of their dependency on claim 26.
Regarding claim 28, claim 28 recites the limitation "the photo-detector" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes “the photo-detector” is interpreted as the “optical detector” established in claim 26. It is suggested to recite “the photo-detector” as “the optical detector” if referring to the same element.
Regarding claim 31, claim 31 recites the limitation "the plurality of biological indicator holders" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Note that claim 26 only recites a singular “biological indicator holder”.
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 26, 28, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Franciskovich et al. (US 20150147773 A1) in view of Swaminathan et al. (US 20180015193 A1; cited in the IDS filed 10/27/2023) and Courtney (US 20150233828 A1).
Regarding claim 26, Franciskovich teaches a method for determining the effectiveness of at least a sterilization process (abstract; [0001]; Figs. 1-8), the method comprising
providing a biological indicator reader (Figs. 1-2 and [0082], step 202 teaches providing an incubator and reader system 100, i.e. biological indicator reader) for reading a plurality of biological indicators to determine the effectiveness of at least a sterilization process to determine the effectiveness of at least a sterilization process ([0064] teaches biological indicators to determine the efficacy of a sterilization process; [0075],[0077] teaches the photodetector of the system is used to detect different types of sterilization indicators), each biological indicator configured to exhibit fluorescence when the sterilization process has failed ([0004]-[0006] teaches biological indicators exhibit growth and fluorescence when sterilization is not adequate or fails; [0072] teaches fluorescence emitted by metabolic products of surviving microorganisms in the biological indicator; [0075],[0077] teaches fluorescence produced by surviving microorganisms and the photodetector of the system is used to detect different wavelengths of different types of sterilization indicators; [0088] teaches deeming the sterilization has failed based on the sampling output readings from the photodetector; therefore, the indicators exhibit fluorescence when sterilization has failed, i.e. growth of the indicators lead to fluorescence which indicators sterilization has failed);
activating the biological indicator (Fig. 2, step 206);
placing the activated biological indicator in a biological indicator holder for the detection of fluorescence (Figs. 1-2, step 208 and [0072],[0084] teaches placing the activated sterilization indicator in a well 108 of the system for detection of fluorescence with photodetector 122);
incubating the activated biological indicator at a preselected temperature for a preselected time (Fig. 2 and [0085], step 212);
emitting light from a light emitter through an aperture on a side of the biological indicator holder (Figs. 1-2 and [0086], teaches step 214 of directing light from a light source 188 through an aperture 120 on a side of the well 108); and
detecting fluorescence intensity by an optical detector indicating the effectiveness of the sterilization process (Figs. 1-2 and [0078],[0087]-[0088] teaches detecting intensity of light from the biological indicator by a photodetector, where the sterilization has failed or is not efficacious based on the sampling output readings from the photodetector; [0072],[0110] teaches detecting fluorescence light generated by surviving microorganisms; therefore, the fluorescence intensity indicates the effectiveness of the sterilization process).
Franciskovich fails to teach: placing each biological indicator inside a biological indicator crusher of the reader to activate the biological indicator; emitting UV light from a UV light emitter through an aperture on a side of the biological indicator holder; and detecting fluorescence intensity by an optical detector positioned at a bottom of the reader indicating the effectiveness of the sterilization process.
Franciskovich teaches evaluation of biological indicators using UV light from UV-emitting lamps that pass through the biological sample and on a separate, moveable printed circuit board there resides a single detector that must be moved to align with each of the through-holes so that the detector passes in front of each sample location in turn ([0006]). Franciskovich teaches excitation wavelength may be varied as needed to provide for use of a wide range of biological indicators in the sterilization indicator ([0077]).
Swaminathan teaches a self-contained biological sterilization indicator for determining the efficacy of a sterilization process (abstract; [0007]). Swaminathan teaches if a sterilization cycle fails, the sterilization indicator generates a detectable signal indicating that the biological specimen survived; and the detectable signal is commonly an indication such as a color change or the emission of a luminescent or fluorescent signal ([0003]). Swaminathan teaches a well-known type of self-contained sterilization indicator using an outer container and a sealed inner container containing growth medium, where the inner container is crushed after sterilization to interact with the spores, and incubated, and determining sterilization failure depending on color change ([0004]). Swaminathan teaches dual rapid-readout indicators are self-contained sterilization indicators that test the effectiveness of a sterilization procedure by measuring both enzyme activity and spore growth following exposure to a sterilization procedure ([0006]). Swaminathan teaches the inner container of the self-contained biological sterilization indicator is adapted so that it may be broken to allow the enzyme substrate to react with the active enzyme to form an enzyme-modified product that provides a detectable indication of the failure of a sterilization procedure ([0064]). Swaminathan teaches a method for testing the effectiveness of a sterilization procedure includes a plurality of test microorganisms useful to detect exposure to a sterilant and correlating the presence of the detectable indication with failure of the sterilization procedure or correlating the absence of the detectable indication with success of the sterilization procedure ([0085]). Swaminathan teaches biological indicators activated by crushing an ampoule inside of an outer container, incubating the indicators, and observing the indicators to determine whether any spores survived sterilization process ([0172]). Swaminathan teaches a carrier may be transmissive to ultraviolet wavelengths ([0103]). Swaminathan teaches self-contained sterilization indicators, are recognized in the art as providing an accurate and precise means for testing the effectiveness of a sterilization procedure ([0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Franciskovich to incorporate Franciskovich’s teachings of evaluation of biological indicators using UV light ([0006]) and Swaminathan’s teachings of a self-contained biological sterilization indicator for determining the efficacy of a sterilization process by crushing an ampoule to activate biological indicators (abstract; [0003]-[0004],[0006]-[0007],[0064],[0085], [0172]) and a carrier being transmissive to UV wavelengths ([0103]) to provide: placing each biological indicator inside a biological indicator crusher of the reader to activate the biological indicator; emitting UV light from a UV light emitter through an aperture on a side of the biological indicator holder. Doing so would have a reasonable expectation of successfully improving accuracy and precision of testing for effectiveness of a sterilization process as taught by Swaminathan using known methods (e.g. crushing an ampoule with biological indicators for activation; UV light).
Modified Franciskovich fails to teach: detecting fluorescence intensity by an optical detector positioned at a bottom of the reader indicating the effectiveness of the sterilization process.
Courtney teaches a device for optically measuring fluorescence in a test sample (abstract). Courtney teaches the device (Figs. 1-2) includes an LED (LED 24) configured to emit a excitation light for exciting a fluorescent dye in a sample through an aperture on the side of the device (Fig. 2; [0045]). Courtney teaches the device (Figs. 1-2) includes a photodiode (photodiode 28) positioned at a bottom of the device for detecting fluorescence that exits the bottom of a tube (Fig. 2; [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the positions of the UV light emitter and optical detector of modified Franciskovich to incorporate Courtney’s teachings of known alternatives of positioning a light emitter and optical detector for fluorescence detection of a sample (Figs. 1-2; [0045]) to provide: detecting fluorescence intensity by an optical detector positioned at a bottom of the reader indicating the effectiveness of the sterilization process. Doing so would have a reasonable expectation of successfully allowing for detection of fluorescence as taught by Courtney. Additionally, doing so would have been an obvious matter of design choice with the expected result of allowing for emitting light to the biological indicator and measuring fluorescence (See MPEP 2144.04 (VI)(C); In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975)).
Regarding claim 28, modified Franciskovich fails to explicitly teach: wherein when the biological indicator holder is empty, the photo-detector emits a signal that is under a lower threshold value; and when the biological indicator is in the biological indicator holder, the signal is above an upper threshold value.
Franciskovich teaches the photodetector is controlled and provides data to a control system with a user interface, where the user interface includes a readout of the intensity and wavelength of the exit light emanating from a vial, which is used for determination of the proper fill level, activation state or positioning of the vial and of the light produced by the microorganisms ([0078]). Franciskovich teaches the user interface includes an indicator light associated with each well, i.e. holder, which indicates presence of a vial in the associated well ([0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Franciskovich to incorporate the teachings of using photodetector signals to determine proper positioning of a vial in a well and indicating of the presence of a vial in the well of Franciskovich ([0078],[0104]) to provide: wherein when the biological indicator holder is empty, the photo-detector emits a signal that is under a lower threshold value; and when the biological indicator is in the biological indicator holder, the signal is above an upper threshold value. Doing so would have a reasonable expectation of successfully improving user indication of the presence or absence of a vial in the biological indicator holder, therefore ensuring proper positioning of the holder.
Regarding claim 31, modified Franciskovich fails to teach: wherein the biological indicator reader further comprises a horizontal circuit board positioned under the plurality of biological indicator holders and a vertical circuit board orthogonal to the horizontal circuit board and proximate the biological indicator holders, and the UV light emitter is mounted on the vertical circuit board and the optical detector is mounted on the horizontal circuit board.
Franciskovich teaches evaluation of biological indicators using UV light from UV-emitting lamps that pass through the biological sample and on a separate, moveable printed circuit board there resides a single detector that must be moved to align with each of the through-holes so that the detector passes in front of each sample location in turn ([0006]).
Courtney teaches the device (Figs. 1-2) further comprises a horizontal circuit board (58) positioned under a plurality of holders (Figs. 1-4 shows printed circuit board 58 under a plurality of sample wells) and a vertical circuit board (56) orthogonal to the horizontal circuit board (Figs. 1-4) and proximate the plurality of holders (Figs. 1-4), and the light emitter (24) is mounted on the vertical circuit board (Figs. 1-4) and the optical detector is mounted on the horizontal circuit board (Figs. 1-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biological reader of modified Franciskovich to incorporate Franciskovich’s teachings of UV-emitting lamps and a printed circuit board with a detector ([0006]) and Courtney’s teachings of an optical detector on a horizontal circuit board a light emitter on a vertical circuit board (Figs. 1-4) to provide: wherein the biological indicator reader further comprises a horizontal circuit board positioned under the plurality of biological indicator holders and a vertical circuit board orthogonal to the horizontal circuit board and proximate the biological indicator holders, and the UV light emitter is mounted on the vertical circuit board and the optical detector is mounted on the horizontal circuit board. Doing so would have a reasonable expectation of successfully improving electrical connection of the UV light emitter in relation to the optical detector.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the claimed optical detector on a horizontal circuit board UV light emitter on a vertical circuit board) by known methods with no change in their respective functions (i.e. emitting UV light from the side and detecting light from the bottom), and the combinations yielded nothing more than predictable results (i.e. providing the claimed optical detector on a horizontal circuit board UV light emitter on a vertical circuit board would yield nothing more than the obvious and predictable result of providing electrical connection and control of the UV light emitter in relation to the optical detector). See MPEP 2143(A).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 26 and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 33 of copending Application No. 18/259,830 (herein, “App ‘830”) in view of Swaminathan et al. (US 20180015193 A1; cited in the IDS filed 10/27/2023) and Courtney (US 20150233828 A1).
Regarding claim 26, App ‘830 recites a method for determining the effectiveness of at least a sterilization process (claim 33), the method comprising providing a biological indicator reader for reading a plurality of biological indicators to determine the effectiveness of at least a sterilization process to determine the effectiveness of at least a sterilization process (claim 33), each biological indicator configured to exhibit fluorescence when the sterilization process has failed (claim 33); activating the biological indicator by crushing the biological indicator (claim 33 recites crushing the crushable container of the biological indicator to activate the selected biological indicator); placing the activated biological indicator in a biological indicator holder for the detection of fluorescence (claim 33 teaches incubating the activated biological indicator in the holders and then detecting fluorescence); incubating the activated biological indicator at a preselected temperature for a preselected time (claim 33); emitting UV light from a UV light emitter through an aperture on a side of the biological indicator holder (claim 33); and detecting fluorescence intensity by an optical detector indicating the effectiveness of the sterilization process (claim 33).
App ‘830 fails to recite placing each biological indicator inside a biological indicator crusher of the reader to activate the biological indicator; and detecting fluorescence intensity by an optical detector positioned at a bottom of the reader indicating the effectiveness of the sterilization process.
Swaminathan teaches a self-contained biological sterilization indicator for determining the efficacy of a sterilization process (abstract; [0007]). Swaminathan teaches if a sterilization cycle fails, the sterilization indicator generates a detectable signal indicating that the biological specimen survived; and the detectable signal is commonly an indication such as a color change or the emission of a luminescent or fluorescent signal ([0003]). Swaminathan teaches a well-known type of self-contained sterilization indicator using an outer container and a sealed inner container containing growth medium, where the inner container is crushed after sterilization to interact with the spores, and incubated, and determining sterilization failure depending on color change ([0004]). Swaminathan teaches dual rapid-readout indicators are self-contained sterilization indicators that test the effectiveness of a sterilization procedure by measuring both enzyme activity and spore growth following exposure to a sterilization procedure ([0006]). Swaminathan teaches the inner container of the self-contained biological sterilization indicator is adapted so that it may be broken to allow the enzyme substrate to react with the active enzyme to form an enzyme-modified product that provides a detectable indication of the failure of a sterilization procedure ([0064]). Swaminathan teaches a method for testing the effectiveness of a sterilization procedure includes a plurality of test microorganisms useful to detect exposure to a sterilant and correlating the presence of the detectable indication with failure of the sterilization procedure or correlating the absence of the detectable indication with success of the sterilization procedure ([0085]). Swaminathan teaches biological indicators activated by crushing an ampoule inside of an outer container, incubating the indicators, and observing the indicators to determine whether any spores survived sterilization process ([0172]). Swaminathan teaches a carrier may be transmissive to ultraviolet wavelengths ([0103]). Swaminathan teaches self-contained sterilization indicators, are recognized in the art as providing an accurate and precise means for testing the effectiveness of a sterilization procedure ([0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of App ‘830 to incorporate Swaminathan’s teachings of a self-contained biological sterilization indicator for determining the efficacy of a sterilization process by crushing an ampoule to activate biological indicators (abstract; [0003]-[0004],[0006]-[0007],[0064],[0085], [0172]) to provide: placing each biological indicator inside a biological indicator crusher of the reader to activate the biological indicator. Doing so would have a reasonable expectation of successfully improving accuracy and precision of testing for effectiveness of a sterilization process as taught by Swaminathan using known methods (e.g. crushing an ampoule with biological indicators for activation).
Modified App ‘830 fails to recite: detecting fluorescence intensity by an optical detector positioned at a bottom of the reader indicating the effectiveness of the sterilization process.
Courtney teaches a device for optically measuring fluorescence in a test sample (abstract). Courtney teaches the device (Figs. 1-2) includes an LED (LED 24) configured to emit a excitation light for exciting a fluorescent dye in a sample through an aperture on the side of the device (Fig. 2; [0045]). Courtney teaches the device (Figs. 1-2) includes a photodiode (photodiode 28) positioned at a bottom of the device for detecting fluorescence that exits the bottom of a tube (Fig. 2; [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the positions of the UV light emitter and optical detector of modified App ‘830 to incorporate Courtney’s teachings of known alternatives of positioning a light emitter and optical detector for fluorescence detection of a sample (Figs. 1-2; [0045]) to provide: detecting fluorescence intensity by an optical detector positioned at a bottom of the reader indicating the effectiveness of the sterilization process. Doing so would have a reasonable expectation of successfully allowing for detection of fluorescence as taught by Courtney. Additionally, doing so would have been an obvious matter of design choice with the expected result of allowing for emitting light to the biological indicator and measuring fluorescence (See MPEP 2144.04 (VI)(C); In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975)).
Regarding claim 31, App ‘830 fails to recite: wherein the biological indicator reader further comprises a horizontal circuit board positioned under the plurality of biological indicator holders and a vertical circuit board orthogonal to the horizontal circuit board and proximate the biological indicator holders, and the UV light emitter is mounted on the vertical circuit board and the optical detector is mounted on the horizontal circuit board.
Courtney teaches the device (Figs. 1-2) further comprises a horizontal circuit board (58) positioned under a plurality of holders (Figs. 1-4 shows printed circuit board 58 under a plurality of sample wells) and a vertical circuit board (56) orthogonal to the horizontal circuit board (Figs. 1-4) and proximate the plurality of holders (Figs. 1-4), and the light emitter (24) is mounted on the vertical circuit board (Figs. 1-4) and the optical detector is mounted on the horizontal circuit board (Figs. 1-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biological reader of modified App ‘830 to incorporate Courtney’s teachings of an optical detector on a horizontal circuit board a light emitter on a vertical circuit board (Figs. 1-4) to provide: wherein the biological indicator reader further comprises a horizontal circuit board positioned under the plurality of biological indicator holders and a vertical circuit board orthogonal to the horizontal circuit board and proximate the biological indicator holders, and the UV light emitter is mounted on the vertical circuit board and the optical detector is mounted on the horizontal circuit board. Doing so would have a reasonable expectation of successfully improving electrical connection of the UV light emitter in relation to the optical detector.
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lee et al. (US 5952218 A1) teaches a bottle retaining mechanism that holds a culture bottle in an incubating apparatus (abstract). Lee teaches if the amount of light detected at the light detector is less than a particular predetermined threshold, than this is an indication of an empty bottle holder cavity (column 3, lines 2-9).
Ludowise et al. (WO 2020183433 A1; cited in the IDS filed 10/27/2023) teaches a method of determining sterilization efficacy based on a plurality of fluorescence readings (abstract; Figs. 11-12); an excitation source producing UV light ([0055]).
Bolen (US 5863790 A; cited in the IDS filed 10/27/2023) teaches a system for determining the efficacy of a sterilization cycle including a biological indicator (BI) that exhibits fluorescence that is indicative of bacterial growth (abstract; Fig. 2A). Bolen teaches an ampule containing growth medium is cracked or crushed for conditioning of spore growth, i.e. activation of the BI (column 9, lines 32-58), and then incubating (column 9, lines 57-58).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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, 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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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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