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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/15/2025 has been entered.
Response to Amendment/Arguments
The Amendment filed 6/5/2025 has been entered. Claims 1-2, 4-7, 9-11, and 35-45 remain pending on the application. Claims 37-45 are withdrawn as being directed towards a non-elected invention pursuant to 37 CFR 1.142(b). Applicant’s amendments to the claims have overcome the 35 U.S.C. 112(b) rejections previously set forth in the Final Office Action filed 8/27/2025.
Applicant argues:
In this Action, and in view of the Previous Response, it was asserted that Taggart "explicitly teaches using indicators that change to a lighter color, rather than a different color (par. 106: Other indicators useful in the sterilization device include organic dyes that turn a lighter color) such that the use of a more nuanced color evaluation method is necessary." (Action, pg. 6.) However, Taggart merely teaches simple color changes of chemical indicators, which may be compared to a reference color for simply determining if a sterilization process was effective. For example, Taggart discloses that:
"a chemical indicator changes color under oxidation signifying a certain level of sterilant or sterilant component efficacy. Other indicators useful in the sterilization device include organic dyes that turn a lighter color, for example, when oxidized and/or in the presence of humidity.
The user, or the device through a sensor, compares the color to a reference ring surrounding
the indicator to determine if the process was effective. In an example aspect, chemical indicators are useful as a method or process validation and record retention (routine process monitoring) to demonstrate specified process conditions were met." (Taggart, [0108].)
Thus, Taggart fails to teach or disclose assessing an efficacy of a sterilization procedure from an image of the chemical indicator, when the image includes or has "non-uniform color changes." Additionally, there would be no reason for a person having ordinary skill in the art to modify the method or device of Taggart with the method of Kawabata for "determining an averaged color valve of the image of the chemical indicator," as the method and device of Taggart only require determination of simple color changes, compared to a threshold valve, in order to determine if a sterilization process was effective. Accordingly, Applicant respectfully submits that the rejections of independent claims 1 and 37 should be withdrawn.
Taggart is silent as to whether or not the chemical indicators used are capable of non-uniform color changes and therefore, there would still be motivation to specifically have an automated color evaluation method that can read non-uniform chemical indicators just in case, which also allows for flexibility of use of different indicators. In addition, a new reference, Graessle, is used to read on a chemical indicator having non-uniform color changes.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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, 4-7, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over of Taggart (US 20170304476 A1, provided in Applicant’s IDS of 10/29/2021) in view of Graessle (CN 1151703 A) and Kawabata (US 20130250322 A1).
Regarding claim 1, Taggart teaches a method comprising: obtaining an image of a chemical indicator associated with a load to be sterilized in a sterilization procedure… assessing an efficacy of the sterilization procedure (par. 119: In step 840, the user optionally places a chemical indicator face up in front left corner of chamber; par. 106: In an example aspect, the sterilization device includes a chemical indicator or other measurement element to determine or provide a measure of sterilant efficacy or other parameter. The chemical indicator or measurement element provides a parameter indicator of one or more separate elements of the sterilant. In an example aspect, a chemical indicator changes color under oxidation signifying a certain level of sterilant or sterilant component efficacy. Other indicators useful in the sterilization device include organic dyes that turn a lighter color, for example, when oxidized and/or in the presence of humidity. The user, or the device through a sensor, compares the color to a reference ring surrounding the indicator to determine if the process was effective. In an example aspect, chemical indicators are useful as a method or process validation and record retention (routine process monitoring) to demonstrate specified process conditions were met), but does not teach
determining an averaged color value of the image of the chemical indicator having non-uniform color changes; and based on a comparison of a color-value threshold and the averaged color value of the image of the chemical indicator.
Taggart not teach wherein the chemical indicator has non-uniform color changes.
Graessle teaches a device for measuring the extent of sterilization (abstract: An independent electronic testing device (2) which is set in the sterilizing chamber, the sterilizing cycle monitoring and recording two environment parameters of a predetermined position. The device provides a permeable medium (12) penetrating the disinfectant to the first position, measuring a first environmental condition with a first sensor (38), second sensor (36) for measuring the sterilizing chamber in the second environment condition. recording the device and first and second environmental conditions and time data from a timer in the device-related data. The device can further process the data to determine whether sufficient sterilant penetration, or transmits the data to the external device for processing).
Graessle teaches wherein the chemical indicator is capable of non-uniform color changes (pg. 3 par. 3: the result of steam penetration is not sufficient on the surface of a chemical indicator test paper generating non- uniform coloration). This is useful for indicating that sterilization was incomplete.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Taggart to use chemical indicators capable of non-uniform color changes, as taught by Graessle, in order to indicate incomplete sterilization.
Taggart modified by Graessle still does not teach determining an averaged color value of the image of the chemical indicator s; and based on a comparison of a color-value threshold and the averaged color value of the image of the chemical indicator.
Taggart teaches a device for evaluating the color of an indicator by comparing it to a reference ring, which is interpreted to be the color-value threshold, as well as for recognizing a color change to a lighter color (par. 106: Other indicators useful in the sterilization device include organic dyes that turn a lighter color, but does not teach a specific method for evaluating that color change. If the color change of the indicator of Taggart were to be automated, the color value would need to be averaged because of potential lighting differences that would read as different colors to a camera. In addition, since Taggart does not specify what type of indicator is specifically used, it would be safest to use an automated color evaluation system that averages the color values so that both uniform and non-uniform color changing indicators can be used.
Kawabata teaches a method for evaluating how close one image is to another in terms of color (abstract: A color information processing method includes: inputting reference data including color information about each pixel or each pixel group of a reference medium and evaluation target data including color information about each pixel or each pixel group of an evaluation medium by an input means; performing an image matching process of image matching the input reference data and evaluation target data; setting a specific area which is a unit of evaluation and includes a plurality of pixels to each data item subjected to the image matching process; and comparing the color information items about each pixel or each pixel group in the reference data and the evaluation target data in the set specific area to calculate a color difference and performing an averaging process to calculate an average evaluation result for the specific area by a calculation means).
Kawabata teaches evaluating the color of one image by averaging the colors of its individual pixels, which includes L*a*b* values, and comparing that average to that of another image, which is interpreted to be a color-value threshold (par. 108: The .DELTA.E calculation means 7 compares the pixel group average color information /L*a*b* values for each pixel group in the specific areas in each of the images of the proof sheet and the printed test sheet which are image-matched on each other to calculate the color difference (pixel group color difference) .DELTA.E of each pixel group; par. 120: In this case, it is possible to easily check the color difference and it is possible to easily and rapidly determine whether the analysis result of the image is good based on the evaluation result based on the color measurement result obtained by the image area color measurement. In addition, the colorimetric value or the color difference value can be displayed by the color difference average (or the average of the measured values of each pixel) of each pixel of the reference image and the evaluation image, the average color difference (or the comparison between the average values of all pixels), or a combination of the color difference average and the average color difference).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Taggart modified by Graessle to determine whether or not the color of the chemical indicator is the desired color by comparing the averaged color value of the image of the indicator to a color-value threshold, as taught by Kawabata, in order to implement a method for evaluating the color of an image that can account for more nuanced changes in color.
Regarding claim 4, Taggart modified by Graessle and Kawabata teaches the method of claim 1, and teaches further comprising averaging the image of the chemical indicator to create an averaged image such that determining the averaged color value of the image comprises determining a color value of the averaged image (see Kawabata modification in claim 1 rejection)).
Regarding claim 5, Taggart modified by Graessle and Kawabata teaches the method of claim 1, but does not teach wherein the averaged color value comprises an a* value.
Kawabata teaches wherein the averaged color value comprises an a* value as one way to evaluate color (par. 108: The .DELTA.E calculation means 7 compares the pixel group average color information /L*a*b* values for each pixel group in the specific areas in each of the images of the proof sheet and the printed test sheet which are image-matched on each other to calculate the color difference (pixel group color difference) .DELTA.E of each pixel group; par. 110: Specifically, a general pixel color difference .DELTA.E is obtained by image matching the image of the reference medium and the image of the evaluation medium and subtracting an evaluation L*a*b* value from a reference L*a*b* value for each pixel of the same picture portion (for example, the same specific area or the same matrix frame A3) and is represented by the following Equation (1)).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the averaged color value of Taggart modified by Graessle and Kawabata to comprise an a* value, as one means of evaluating the color of an image.
Regarding claim 6, Taggart modified by Graessle and Kawabata teaches the method of claim 5, and teaches wherein the color-value threshold comprises an a* value (see Kawabata modification in claim 1 rejection), but does not teach wherein the color-value threshold comprises an a* value between approximately -9 and 9.
However, a mere change in the degree of a variable, even if it leads to better results, holds no patentable significance:
MPEP 2144.05.II.A: Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
especially if it can be shown that the change in degree can be done by one of ordinary skill in the art through routine optimization of a known result-effective variable (MPEP 2144.05.II.B: the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process).
In this case, the a* value for the color-value threshold depends on what indicator is being used and what color the indicator shows when the sterilization is adequate. One of ordinary skill in the art would be able to determine the a* value range corresponding to said color.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Taggart modified by Graessle and Kawabata to have a color-value threshold that comprises an a* value between approximately -9 and 9, with the reasonable expectation that the a* value would indicate that adequate sterilization has been achieved.
Regarding claim 7, Taggart modified by Graessle and Kawabata teaches the method of claim 6, and teaches wherein the color-value threshold comprises an a* value (see Kawabata modification in claim 1 rejection), but does not teach wherein the color-value threshold comprises an a* value of approximately 0.
However, a mere change in the degree of a variable, even if it leads to better results, holds no patentable significance:
MPEP 2144.05.II.A: Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
especially if it can be shown that the change in degree can be done by one of ordinary skill in the art through routine optimization of a known result-effective variable (MPEP 2144.05.II.B: the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process).
In this case, the a* value for the color-value threshold depends on what indicator is being used and what color the indicator shows when the sterilization is adequate. One of ordinary skill in the art would be able to determine the a* value corresponding to said color.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Taggart modified by Graessle and Kawabata to have a color-value threshold that comprises an a* value of approximately 0, with the reasonable expectation that the a* value would indicate that adequate sterilization has been achieved.
Regarding claim 9, Taggart modified by Graessle and Kawabata teaches the method of claim 1, but does not teach wherein the averaged color value comprises a grayscale value.
Kawabata teaches wherein color values in general may be used to evaluate color, one of which is a grayscale value (par. 88: However, in this embodiment, the pixel means a minimum unit or a minimum component with color information (a color tone or a grayscale level) when a computer treats the image; par. 120: In addition, the colorimetric value or the color difference value can be displayed by the color difference average (or the average of the measured values of each pixel) of each pixel of the reference image and the evaluation image, the average color difference (or the comparison between the average values of all pixels), or a combination of the color difference average and the average color difference; par. 20: and comparing the color information items about each pixel or each pixel group in the reference data and the evaluation target data in the set specific area to calculate a color difference and performing an averaging process to calculate an average evaluation result for the specific area by a calculation means; par. 145: However, the maximum density value (255-th step in the case of 256 grayscale levels of 0 to 255); NOTE: from this line, Kawabata considers grayscale values to be measuring density; par. 36: the color information of the evaluation target data as a color measurement result of a spectral value, an L*a*b* value, an RGB value, a CMYK value, an XYZ value, a density value).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the color-values, including those of the threshold and those that are averaged, of Taggart modified by Graessle and Kawabata to comprise a grayscale value, as taught by Kawabata, as one color information means for comparing the colors between two images.
Regarding claim 10, Taggart modified by Graessle and Kawabata teaches the method of claim 9, and teaches wherein the color-value threshold comprises a gray scale value (see Kawabata modification in claim 9 rejection) but does not teach that is between approximately 50% and approximately 60% black.
However, a mere change in the degree of a variable, even if it leads to better results, holds no patentable significance:
MPEP 2144.05.II.A: Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
especially if it can be shown that the change in degree can be done by one of ordinary skill in the art through routine optimization of a known result-effective variable (MPEP 2144.05.II.B: the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process).
In this case, the grayscale value for the color-value threshold depends on what indicator is being used and what color the indicator shows when the sterilization is adequate. One of ordinary skill in the art would be able to determine the grayscale value range corresponding to said color.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Taggart modified by Graessle and Kawabata to have a color-value threshold that comprises a grayscale value of approximately 50% to 60% black, with the reasonable expectation that the grayscale value would indicate that adequate sterilization has been achieved.
Regarding claim 11, Taggart modified by Graessle and Kawabata teaches the method of claim 10, and teaches wherein the color-value threshold comprises a gray scale value (see Kawabata modification in claim 9 rejection) but does not teach of approximately 54%.
However, a mere change in the degree of a variable, even if it leads to better results, holds no patentable significance:
MPEP 2144.05.II.A: Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
especially if it can be shown that the change in degree can be done by one of ordinary skill in the art through routine optimization of a known result-effective variable (MPEP 2144.05.II.B: the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process).
In this case, the grayscale value for the color-value threshold depends on what indicator is being used and what color the indicator shows when the sterilization is adequate. One of ordinary skill in the art would be able to determine the grayscale value corresponding to said color.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Taggart modified by Graessle and Kawabata to have a color-value threshold that comprises a grayscale value of approximately 54%, with the reasonable expectation that the grayscale value would indicate that adequate sterilization has been achieved.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over of Taggart modified by Graessle and Kawabata in view of Fujii (JP 2018064878 A, provided in Applicant’s IDS of 5/32/2024).
Regarding claim 2, Taggart modified by Graessle and Kawabata teaches the method of claim 1, but does not teach further comprising automatically opening a door of the chamber after the sterilization procedure has ended.
Taggart already teaches a method involving a sealable sterilization chamber (par. 5: . According to certain implementations of the disclosure, a portable sterilization device for use with one or more sterilants includes a sealable sterilization chamber having one or more walls defining a sealable internal volume) and teaches wherein the chamber is unsealed after the sterilization procedure has ended (PAR. 69: After successful completion of sterilant exposure to the contents, a breakdown process is initiated in order to prepare the system for being unsealed and for the contents to be safely removed) but does not teach wherein the chamber has a door that is automatically unsealed.
Fujii teaches a sterilization chamber (abstract: To provide a method for operating a steam sterilizer system in which the energy loss is prevented as well as the heat deterioration of an object to be sterilized is prevented, by preventing the wasteful supply of steam to the steam jacket for a long time after the finish of the sterilizer operation. SOLUTION: In the sterilizer tank 2, an object to be sterilized is received as well as steam is supplied to sterilize the object to be sterilized). Fujii teaches automatically opening a door to the sterilization chamber after the sterilization cycle has finished (pg. 7 par. 2: In the post-processing step S6, the steam supply to the steam jacket 3 is stopped and the door of the sterilization tank 2 is automatically opened), which makes it more convenient for the user to know that the procedure has been finished and subsequently access the sterilized contents.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Taggart modified by Graessle and Kawabata to use a door to seal the sterilization chamber and open said door when the sterilization procedure is completed, as taught by Fujii, in order to make it more convenient for the user to know that the procedure has been finished and subsequently access the sterilized contents.
Allowable Subject Matter
Claims 35 and 36 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.
Regarding claim 35, Taggart modified by Graessle and Kawabata teaches the method of claim 1, but does not teach further comprising automatically ending the sterilization procedure following a determination that the averaged color value passed the color-value threshold.
Furthermore, it would not be obvious to modify method of Taggart to do this since Taggart specifically teaches using a timed sterilization cycle so that the sterilization can be conducted for a period that is more than adequate according to FDA standards (par. 114: For FDA compliance the exposure time is then at minimum doubled to attain <overkill>, resulting in a SAL of 10.sup.−6.).
Regarding claim 36, Taggart modified by Graessle and Kawabata teaches the method of claim 1, but does not teach further comprising waiting for a dwell time following a determination that the averaged color value has not passed the color-value threshold.
Dean (US 20060054526 A1) and Ellwanger (DE 102005048968 A1) teach methods of evaluating the color change in chemical indicators using a CIELAB system in order to indicate the effectiveness of sterilization, but do not teach using these evaluations to determine whether or not to end the sterilization process. Other prior art mentioning specific color scales also usually evaluate indicators AFTER a completed sterilization, rather than during a sterilization cycle.
Conclusion
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/C.C./Examiner, Art Unit 1796
/DONALD R SPAMER/Primary Examiner, Art Unit 1799