DETAILED ACTION
This is the first action in response to US Patent Application No. 18/281,371, filed 11 September, 2023, as the National Stage Entry of International Application PCT/IB22/52073, filed 09 March, 2022, and with priority to Foreign Application GB 2103261.0, filed 09 March, 2021.
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 Amendment
The preliminary amendments filed 11 September, 2023, are acknowledged. Claims 3-5, 7, 11-13, 16, 18, 20-21, 23, 28-29, 33 and 36 are amended. Claims 6, 8-10, 14-15, 17, 19, 24-27, 30, 32 and 34-35 are cancelled. Claims 1-5, 7, 11-13, 16, 18, 20-23, 28-29, 31, 33, and 36 are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
This application includes two claim limitations that use the word “means” but are nonetheless not being interpreted under 35 U.S.C. 112(f) because the claim limitations do not meet all criteria of the three prong test.
Claim 13 recites the limitation “exposure correction means”. Despite including the term “means”, this limitation is not interpreted as invoking 112(f) because the claim does not clearly limit the term “means” with functional language linked with a transition word such as “for”. Also, the specification does not provide a clear definition or example of such means. The limitation “exposure correction means” is understood to refer to a software package or device capable of adjusting or analyzing data from an optical detector so that the color of the sensor patch can be determined consistently regardless of ambient light conditions; for example, the exposure correction means may comprise software which accounts for the brightness and color of ambient light in order to accurately determine the color of the sensor patch.
Claim 29 recites the limitation “memory means”. Despite including the term “means”, this limitation is not interpreted as invoking 112(f) because the claim does not clearly limit the term “means with functional language linked with a transition word such as “for”. Also, despite being indefinite (see rejection under 35 U.S.C. 112(b) below), the claim does recite an embodiment of memory means (“a remote database”) sufficient to perform the storing function recited in claim 29.
These limitations are not being interpreted under 35 U.S.C. 112(f) and thus are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Objections
Claims 20 and 31 are objected to for the informalities indicated below.
Claim 20 is objected to because the system claim appears to be limited as “comprising” a method step which is not clearly linked to a structure of system. Claim 20 should be adjusted to clarify how the recited step relates to the structure of the claimed system. For example, claim 20 could be adjusted at lines 2-3 as follows: “wherein the system is configured to perform a scaling step in which images are scaled to a standard size”.
Claim 31 is objected to because lines 1-2 of the claim should be adjusted as follows: “the substrate comprising a material coated thereon with at least one chemical…”. Alternative linking words in place of the suggested “comprising” may be appropriate.
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.
Claims 18, 21, 29, 33, and 36 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 18, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Particularly, it is not clear if the claimed “position signal” must be “GPS signal data”, or if the claimed “position signal” includes other signals indicating the location of the substrate. The phrase “such as” should be removed from the claim. Also, if the claim is not intended to be limited only to GPS signals, the entire phrase “such as a GPS signal data” (line 2) should be removed.
Additionally, the term “the location of the substrate” (lines 2-3) of the claim lacks proper antecedent basis in claim 18, and the claim includes grammatical informalities with respect to the term “a GPS signal data” (line 2) and the phrasing of “associated with”.
Accordingly, if the claim is intended to be limited to GPS signals, it is suggested the claim be adjusted at lines 2-3 as follows: “wherein a position signal, which is a GPS signal data, indicates a location of the substrate and is
Regarding claim 21, the claim limitation “indication mechanism” invokes 35 U.S.C. 112(f), because: A) the limitation includes the generic placeholder “mechanism”; B) claim 21 modifies the generic placeholder “mechanism” with the functional language “operable to provide an indication as to the effectiveness of the sanitising process dependent on the colour of the sensor patch”; and C) claim 21 does not recite the actual structure of the indication mechanism which facilitate such function. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Although the originally filed specification at page 6, lines 6-19 discusses the functions of the indication mechanism in providing an indication of a “pass” or “fail” in accordance with an algorithm, the written description does not disclose the actual structure of the claimed indication mechanism. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) because the scope of the claim is not clear.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f);
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding claim 29, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Particularly, it is not clear if the memory means must be “a remote database”, or if the claim encompasses alternative memory means as well. The phrase “such as” should be removed from the claim and the claim should be adjusted to clarify the intended scope of the claim.
Claims 33 and 36 recite the phrase “the sensor patch” with insufficient antecedent basis (lines 2-3 of claim 33, line 3 of claim 36). It is suggested that claim 31 be adjusted to recite “a sensor patch” to establish antecedent basis for the limitation in dependent claims 33 and 36.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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 1-3, 13, 16, 21, and 31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gordon et al. (US 2021/0085811 A1, filed 15 September, 2020).
Regarding claim 1, Gordon teaches a sanitising process detection system (apparatus for measuring a dosage of disinfection light—abstract; includes dosage reading label 300—[0040], Figs 3-6—and a device 712/smartphone 702 for interpreting the UVC dosage information on the UVC dosage reading label—[0063], Figs. 7A-7B and 12) comprising:
a substrate (301) with a sensor patch (UV dosage measurement pad 304) which is impregnated with a chemical (photochromic material) which produces a colour change on exposure to a disinfecting and/or sterilising agent (UV dosage measurement pad 304 infused with a photochromic material so that the UV dosage measurement pad 304 changes its color in response to the total dosage of the UV light incident thereon—[0039]; UV dosage measurement pad 304 disposed on substrate 301—[0040]—such as by a suitable printing technique—[0041]; note that UV light fairly defines a disinfecting/sterilising agent to which the sensor patch is exposed, and that color patch 304 and related components. I.e., 303a-n, 306a-c, generally corresponds to the similar embodiments 204 and 404 of color patches and their associated components);
an optical detector (device 712) includes a processor (µ-processor 702) and an optical sensor (camera 722) which is operative to detect the colour change (device 712, such as smartphone 702, for interpreting the UVC dosage information on a UVC dosage reading label includes a µ-processor 702, a camera 722 for capturing an image of a UVC dosage reading label, an image processing unit 728, a barcode reader 723, a QR code reader 724, a colorimeter reader 726 for converting the color of the measurement pad into the UV dosage incident on the measurement pad, a display 730, a light compensation unit 734, and a lookup table 732; colorimeter reader 726 compares UV dosage measurement pad 204/304 to reference 203/303—[0064]; thus evident that device 712 detects the change in color of pad 204/304 ); and the processor is operative to compare the colour change with a datum (e.g., color units 202a-n/303a-n) to indicate efficacy of the sanitising process (color of pad 204/304 compared to color of units 203/303 to determine the dosage of UV light incident on the UV dosage measurement pad and display the UV dosage information on the display 730—[0064]; reference dosage color 306a-306c may correspond to UVC dosages sufficient for disinfecting various pathogens of interest—[0039]—such as 16, 40, and 100 mJ/cm2—[0036]—or any dosage value deemed important for a particular application—[0055]; NSF recognizes 16 mJ/cm2, 40 mJ/cm2, as the standard UV dosages required to deactivate various bacteria pathogens—[0030]—and 100 mJ/cm2 may correspond to a maximum dosage—[0037]; from the above, it is evident that indication of the dosage of UV provided by the device 714 of Gordon acts as an indication of whether an ultraviolet sanitizing process delivered a sufficient dosage of UV light to deactivate a particular class of microorganism, and thus serves as an indication of an “efficacy of the sanitizing process”).
Regarding claim 2, the independent claim closely overlaps in scope with claim 1 except slightly different language is used to describe the arrangement of the color changing chemical on the substrate. Accordingly, see the rejection of claim 1 above regarding how Gordon teaches a sanitizing process detection system comprising: a substrate (301) with a material (photochromic material) coated thereon, the material has at least one chemical which produces a colour change on exposure to a disinfecting and/or sterilising agent (ultraviolet light) (UV dosage measurement pad 304 includes photochromic material which changes its color in response to the total dosage of incident UV light—[0039]; UV dosage measurement pad 304 disposed on substrate 301—[0040]—such as by a printing—[0041]—printing reasonably defining a type of coating); an optical detector (device 712) includes a processor (µ-processor 702) and an optical sensor (camera 722) which is operative to detect the colour change (see[0064] as cited with respect to claim 1 above); and the processor is operative to compare the colour change with a datum (e.g., 203a-n/303a-n) to indicate the efficacy of the sanitising process (color of pad 204/304 compared to color of units 203/303 to determine dosage of UV light incident on the pad—see [0064]; as discussed with respect to claim 1, it is evident from, e.g., [0030], [0036], [0037], [0039], and [0055], that the determined UV dosage acts as an indication of the efficacy of the sanitising process).
Regarding claim 3, Gordon teaches the sanitising process detection system according to either claim 1. Gordon further teaches the datum (203a-n/303a-n) is a reference colour region on the substrate (color units 303a-n define a scale bar 302 which a user may use to determine the total UV dosage delivered to the UV dosage measurement pad, and reference dosage color bars/patches 306a-c are calibrated to UV dosages sufficient for 3-log killing rates for three different pathogens—[0039], also see related embodiments 203a-n and 206a-c at [0036]-[0038]; colorimeter reader 726 [of device 712] compares the color of the UV dosage measurement pad 204 to the colors of the units 203a-203n of the dosage scale bar 202, and, based on the comparison, determines the dosage of UV light incident on the UV dosage measurement pad 204—[0064]).
Regarding claim 13, Gordon teaches a sanitising process detection system according to any claim 1, wherein the processor includes an exposure correction means (device 712 includes environmental light compensation unit 734 for compensating the environmental light incident on the UVC dosage reading label—[0063]; the environmental light compensation unit 734 may compensate the contribution of the environmental light tot eh colors of the components of the UVC dosage reading labels to thereby eliminate the color cast of environmental light—[0067]; as best understood, such a compensation unit 734 fairly defines an exposure correction means as claimed).
Regarding claim 16, Gordon teaches the sanitising process detection system according to any preceding claim 1. Gordon further teaches the optical detector is included in a smartphone (device 712, such as smartphone 702—[0063]).
Regarding claim 21, Gordon teaches the sanitising process detection system according to claim 1. Gordon further teaches the system further comprises an indication mechanism (display 730) operable to provide an indication as to the effectiveness of the sanitising process (dosage of UV light incident on pad 204/304) dependent on the colour of the sensor patch (colorimeter reader 726 reads the color UV dosage measurement pad 204/304 and the colors of units 203a-n/303a-n and compares the colors of the pad 204/304 to the units 203a-n/303a-n to determine the dosage of UV light incident on the UV dosage measurement pad, and display the UV dosage information on the disapply 730—[0064]; thus, the display unit 730 provides the user with an indication of the UV dosage, and thus the effectiveness of the sanitizing process, dependent on the color of the sensor patch).
Regarding claim 31, Gordon teaches a substrate (label 200,300,400,420,440,510,520,530, 600,704,706; especially labels 520/540 and 706) for use with a sanitising process detection system, the substrate a material coated (printed) thereon with at least one chemical (photochromic material) which produces a colour change on exposure to a disinfecting and/or sterilising agent (UVC light is a disinfecting/sterilising agent) (label 520 includes a UV dosage measurement pad 521 which changes in color when the total UV dosage delivered to the UVC dosage reading label reaches a present value, which reveals a hidden bar code 524—[0051]; pad 521 includes photochromic material—[0052]-[0053]; label 530 similarly reveals QR code 534 as a result of a photochromic material of the label changing in color once a threshold UVC dosage is received by the label—Fig. 5C, [0054]; from related embodiment 300 it is understood that each label includes a substrate [301] on which the photochromic material [304] is printed or otherwise disposed—[0041]), characterized in that the substrate has an identifier (barcode 524 or QR code 534, see Figs. 5B-C).
Claims 1-2, 4-5, 7, 12, 21, 31 and 33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kitamura (US 2022/0226529 A1, with PCT filed 17 January, 2020).
Regarding claim 1, Kitamura teaches a sanitising process detection system (system for determining achievement degree of sterilization process—title, abstract) comprising:
a substrate (chemical indicator [CI] 4) with a sensor patch (discoloration area 30) which is impregnated with a chemical which produces a colour change on exposure to a disinfecting and/or sterilising agent (chemical indicator [CI] 4 is a sheet of test paper that has a discoloration area 30 which has been chemically processed…[so that] the discoloration area 30 changes according to the achievement degree of the sterilization process—[0026]; from background paragraph [0002] it is understood that sterilant agent may be steam, hydrogen peroxide, or other substance; the discoloration area thus fairly defines a sensor patch on the substrate which has been processed to incorporate a chemical which changes color in response to a sterilising agent such as steam or hydrogen peroxide);
an optical detector (measurement apparatus 1 and determination apparatus 20—Fig. 3, [0020]) includes a processor (processor of determination apparatus 20) and an optical sensor (spectrometer 200) which is operative to detect the colour change (spectrometer 200 measures the color of the surface CI 4 and outputs the result of measurement to a control unit 10 including a CPU 11 and nonvolatile memory 12—[0021]; determination apparatus 20 includes a determination unit 501 that determines the achievement degree of a sterilization process based on the result of measurement of the CI 4 performed by the apparatus 1, the determination unit 501 realized by causing on or more processors of the PC to execute a program stored on the storage unit 500—Fig. 3, [0025]); and the processor is operative to compare the colour change with a datum (determination criterion information) to indicate efficacy of the sanitising process (achievement degree of the sterilization process) (determination unit 501 essentially compares the color value of the discoloration area 30 to determination criteria stored on the storage unit 500 to determine the achievement degree of the sterilization process—see [0031]).
Regarding claim 2, since the independent claim is essentially a broader recitation of the system of claim 1, Kitamura teaches the system of claim 2 as indicated with respect to claim 1 above. It is noted that the test paper chemically treated with a discoloration area (30) of Kitamura ([0026]) fairly defines a substrate with a material coated thereon, the material having at least one chemical which produces a color change consistent with claim 2; the limitations of claim 2 are otherwise identical to claim 1 and are thus addressed in the rejection of claim 1 above.
Regarding claim 4, Kitamura teaches a sanitising process detection system according to any preceding claim 1, wherein the optical detector is operative to determine an orientation of the substrate (control unit 10 determines the type and orientation of the CI 4 based on the measured profile of the CI 4—[0029]).
Regarding claim 5, Kitamura teaches a sanitising process detection system according to claim 1, wherein the optical detector is operative to determine a location of the sensor patch (30) (control unit 10 can determine the position of the discoloration area of the CI 4—[0030]).
Regarding claim 7, Kitamura teaches a sanitising process detection system according claim 1, wherein the substrate has an orientation marker (it is possible to determine the orientation of the CI 4 based on the profile from the spectrometer [because the CI are designed with asymmetrical arrangements of identification patterns 31 an discoloration areas depending on type]—see[0027] in combination with Figs. 5A-6B and [0026]; also, a wireless tag can be proved at either end of the CI 4 and allow for determination of the orientation of the CI based on the position of the wireless tag—[0044]; it is also possible to determine the orientation of the CI 4 based on the positions of identification patterns 31 on the CI—[0045]; thus, the various embodiments of identification patterns 31 disclosed by Kitamura or the wireless tag disclosed by Kitamura serve as “orientation markers”).
Regarding claim 12, Kitamura teaches a sanitising process detection system according to any preceding claim 1, wherein the processor includes an edge detector (control unit 10 can determine which side of the chemical indicator 4 is the leading end based on an asymmetrical profile—[0027]; control unit 10 measures profile of CI 4 from leading end of CI to trailing end of CI 4—[0028]; in view of the broad recitation of an “edge detector”, the control unit 10 fairly defines an edge detector because it is able to determine which edge of the chemical indicator is associated with a leading or trailing end).
Regarding claim 21, Kitamura teaches the sanitising process detection system according to claim 1, in which the system further comprises an indication mechanism (notification unit 502) operable to provide an indication as to the effectiveness of the sanitising process dependent on the colour of the sensor patch (notification unit 502 of the determination apparatus 20 notifies the user of the result of determination, and may be configured to display the measured color of the discoloration area, the determined type of CI 4, the result of the determination, a color representing an acceptable “OK” threshold, and a color representing an unacceptable “NG” threshold—see Fig. 8, [0031]; it is evident that “OK” or “NG” are indications of whether or not the sanitizing process was acceptably effective based on comparison of the measured color of discoloration area 30 and the color threshold for acceptable processing).
Regarding claim 31, Kitamura teaches a substrate (chemical indicator [CI] 4) for use with a sanitising process detection system, the substrate a material (sheet of test paper) coated thereon with at least one chemical (discoloration area chemically processed onto sheet of test paper) which produces a colour change on exposure to a disinfecting and/or sterilising agent (color of discoloration rea 30 changes according to the achievement degree of the sterilization process—[0026]; from background paragraphs [0002]-[0003], it is understood that the color change results from the chemical indicator discoloration area being exposed to a sterilizer used in a sterilization process, such as steam or hydrogen peroxide) , characterized in that the substrate has an identifier (identification patterns 31 are used to identify the type of the CI, which may constitute patterns of lines or shapes 52, 53, 62, and 63 printed on the CI 4—[0026]—or a wireless tag disposed on the CI—[0044]—or a barcode, QR code, or the like—[0045]).
Regarding claim 33, Kitamura teaches the substrate according to claim 31, wherein the substrate has an orientation marker which enables an optical detector to orient and locate the sensor patch (it is possible to determine the orientation of the CI 4 based on the profile from the spectrometer [because the CI are designed with asymmetrical arrangements of identification patterns 31 an discoloration areas depending on type]—see[0027] in combination with Figs. 5A-6B and [0026]; control unit 10 can further determine the position of the discoloration area 30 of the CI—[0030]; additionally or alternatively, a wireless tag can also be proved at either end of the CI 4 and allow for determination of the orientation of the CI based on the position of the wireless tag—[0044]; it is also possible to determine the orientation of the CI 4 based on the positions of identification patterns 31 on the CI, which may be configured as barcodes or QR codes—[0045]; thus, the various embodiments of identification patterns 31 disclosed by Kitamura or the wireless tag disclosed by Kitamura serve as “orientation markers” which enable the optical detector to determine an orientation of the chemical indicator and provide determination information that assists in locating the senor patch).
Claims 22-23 and 29 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kato (US 2022/0143252 A1, with PCT filed 19 February, 2020).
Regarding claim 22, Kato teaches a chemical indicator (CI, 2) comprising a sheet-like test paper and a discoloration area (21) which includes a chemical treatment which changes color according to the achievement degree of a sterilization process ([0037]), the chemical indication further including an identification portion (22). A measurement apparatus (1) includes a controller (8) which determines a color value of the discoloration area (21) of a CI based on a measurement result of a measurement unit (3), and the controller outputs the color information to a PC (15) ([0039]). The chemical indicators are loaded alongside sets of items into a sterilizing apparatus (13) (sets are placed in sterilization processing apparatus 13—Fig. 8, [0042]; set including one or more sterilization targets and a first indicator—[0004]; one set is formed by packaging one or more sterilization targets of one group and a chemical indicator using a packaging member—[0031]). Management information including an identification number of a set [which is the identification information of a CI enclosed in the set] and other sterilization related information corresponding to a sterilization process performed on the identified set is stored in a management information table retained on a server (14) (Fig. 9A-C), wherein the sterilization related information includes information on the location (placement) of the set within the sterilizer ([0043]; see right-most column in Figs. 9A-C; operator inputs the zone of the sterilization processing apparatus 13 at which the set was placed to the management system 100—[0046]; the information regarding the zone at which a set has been placed may also be input to a management system by an image sensor–[0047]). The management data can be presented in formats which guide a user to more effectively use the device (management system 100 presents the graph of Fig. 10, which discourages a person form placing a set in zone D—[0048]; position information indication placement position at which a sterilization target is placed is recorded, so that management system 100 can generate information for determining the relationship between the placement position and the achievement degree of the sterilization process—[0053]).
Accordingly, Kato teaches a method of assessing the efficacy of a sanitising process comprising the steps of:
positioning at least one substrate (chemical indicator) which has a sensor patch (discoloration area 21) which produces a colour change on exposure to a disinfecting and/or sterilising agent, the substrate has an identifier (22) ([0037]);
associating the defined location (placement position) of the at least one substrate with its identifier (see Figs. 9A-9C, identification number of chemical indictor is logged alongside its placement position; see [0043], [0046], [0047], and [0053] discussing how the location information is entered into data management system 100)
subjecting the at least one substrate to a sanitising process for a defined time period (operator places a set [including a chemical indicator] in the sterilization processing apparatus, inputs the zone of the apparatus 13 in which the set was placed to the management system 100, and operates the sterilization processing apparatus 13 to perform a sterilization process on the set—[0046]; the sterilization process is fairly implied to last a defined period of time)
retrieving the at least one substrate (2) and using an optical detector to detect a colour change of the sensor patch to derive an indication of the efficacy of the sanitising process at the location at which the substrate was positioned (when the set is used in an operation stage, the discoloration area 21 of a chemical indicator enclosed in the set is measured by the measurement apparatus 1, and the PC 15 determines a level of achievement degree of the sterilization process based on the measured color value and records the determined level—[0046]; note that disclosed embodiments of the measurement apparatus involve the chemical indicator being fed through the apparatus 1—see Figs. 2-7, [0039]-[0040]—such that the measurement of the chemical indicator necessarily requires the chemical indicator first be retrieved from the set; also see Figs. 9C wherein post-sterilization result, placement position, and identification number are all arranged in the table of data management system 100).
Regarding claim 23, Kato teaches the method according to claim 22, including the step of: recording the location of each substrate and recording a score indicative of the efficacy of the sanitising process at the location at which the substrate (chemical indicator 2) was positioned (see Fig. 9C which shoes how the identification information, placement position, and post-sterilization color result are all recorded in a table of the data management system, described at [0046]; also, the post-sterilization color result serves as an indication of sanitization efficacy, with the color values #1-#10 defining achievement degrees which may be defined, for example, such that at a level of #4 to #9 are values indicating an acceptable sanitization result—see [0037]).
Regarding claim 29, Kato teaches a method according to claim 22, and further teaches a step of storing the score indicative of the efficacy of the sanitising process (see Fig. 9C, column for post-sterilization Level #) and/or the time and date stamp (see Fig. 9C, date and time column) and/or location coordinates (See Fig. 9C, placement position; [0052] suggests coordinates may be used to define the placement position) in a memory means (14), such as a remote database (Fig. 9C shows all or the information recorded during the method of Kato as described at [0046]; Kato further indicates that the information of management information is retained by a server apparatus 14—see [0033]).
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kitamura (US 2022/0226529 A1), as applied to claim 1 above, in view of Ha et al. (US 2019/0175776 A1).
Regarding claim 11, Kitamura teaches a sanitising process detection system according to any preceding claim. Kitamura is understood to use different chemical indicators having different indicator compositions depending on the type of sterilization process being monitored (a different Ci us used depending on the sterilization method employed—[0003]; type “A” chemical indicator changes from red to yellow as a result of a sterilization process, and a type “B” chemical indicator changes from green to orange as a result of a sterilization process—[0026]; steam and hydrogen peroxide recognized as two distinct types of sterilizers—[0002]). Kitamura does not explicitly discuss embodiments in which the system is used to assess a sanitising process in which a quaternary ammonium compound, wherein the at least one chemical is a dye which provides a colour change on exposure to quaternary ammonium compounds.
However, in the analogous art of indicator and detection compositions for disinfection compliance monitoring (title), Ha recognizes that quaternary ammonium compounds are one of the most commonly employed chemistries for disinfection and sterilization of surfaces ([0003]) and further teaches an indicator composition for disinfection compliance monitoring ([0008]) which is able to detect quaternary ammonium cleaners and distinguish from certain other sterilant ([0011]). The indicator composition includes at least one xanthene dye as an indicator dye ([0015]), preferably bromo-phenol blue held on a substrate ([0017]), wherein the bromo-phenol allows detection of quaternary ammonium because it turns blue in response to complexing with quaternary ammonium compounds ([[0020]). Therefore, it would be obvious to a person having ordinary skill in the art to adapt the discoloration area (30) of Kitamura to comprise bromo-phenol blue held on the substrate, as seen in Ha ([0017]), for the benefit of detecting when a quaternary ammonium compound has been successfully deployed during a sterilization process (Ha recognized that quaternary ammonium compound are commonly used in sterilization processes—[0003]—and that bromo-phenol blue changes turns blue in response to complexing with quaternary ammonium compounds, allowing the detection of quaternary ammonium—[0020]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. (US 2021/0085811 A1), as applied to claim 16 above, in view of Kato (US 2022/0143252 A1).
Regarding claim 18, Gordon teaches the sanitising process detection system according to either claim 16. Gordon does not teach that a position signal, such as a GPS signal data, indicative of the location of the substrate is, associated with a score efficacy of the sanitising process.
However, in the analogous art of management systems for sterilization process records (title), Kato teaches substrates (chemical indicators 2) including a chemically treated region (discoloration region 21) which changes color in response to a sterilization process (Fig. 4, [0039]), the change in color indicating a degree of sterilization ([0037]). Kato further teaches recording an identification number of the chemical indicator with information on the location of the chemical indicator (placement position) within a sterilizer (13) during a sterilization process and the effectiveness (post-sterilization result) of the sterilization process (see Figs. 9A-C, [0046]-[0047], and [0053]). Kato further suggests that recording such information allows for identification of locations within the sterilizer which are not suitable for sterilizing certain types of loads and enables the system to guide a user to more effectively use the sterilizer (see [0048]-[0049][0051], [0054], [0055]). Therefore, it would be obvious to a person having ordinary skill in the art to configure the system of Gordon to record location data indicative of the location of a substrate during a sterilization process and the associated efficacy score of the process for the benefit of providing the system with data which can be used to identify locations which are not being disinfected properly by a sterilization process and guiding a user to more effectively operate the sterilization process (see Kato at [0048]-[0049], [0051], and [0054]-[0055]).
Additionally, as indicated in the rejection of claim 18 under 35 U.S.C. 112(b) above, claim 18 does not clearly require that the position signal comprise a GPS data signal.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. (US 2021/0085811 A1), as applied to claim 1 above, in view of Sanders et al. (US 2019/0102876 A1).
Regarding claim 20, Gordon teaches the sanitising process detection system according any preceding claim 1. Gordon indicates that the system includes an image processing unit (728) for processing captured images ([0063]-[0064]), but Gordon does not clearly indicate that the system is configured to perform a scaling step in which images are scaled to a standard size.
However, in the analogous art of systems for assessment of the performance of cleaning operations (title, abstract), Sanders teaches a system wherein a camera of a mobile device is arranged to capture an image of a chemical test strip (e.g., 204) ([0200]) and processors of the mobile device are configured to execute a cleaning assessment application which analyzes the image and communicates to a user an assessment of the performance of the cleaning process ([0201]-0202]) based on at least one colorimetric parameter of the image ([0032], [0133]). The analysis of the digital image (Fig. 1, step 4, [0144]) includes an area normalization step (Fig. 2, step 5) in which the size of the image may be scaled with respect to the size of reference pictures or data, especially when only a portion of an indicator area was imaged ([0145]). It is fairly implied that the area normalization (i.e., scaling) step facilitates the computerized analysis of cleaning performance by ensuring that images of corresponding and standardized size are compared. Therefore, it would be obvious to a person having ordinary skill in the art to configure the image processing unit of Gordon to perform a step of scaling images to a standard size, as seen in Sanders (Fig. 2, step 5, [0145]) for the benefit of facilitating the analysis of the captured image by ensuring that the captured image can be compared to a reference image of an equivalent size.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Kato (US 20220143252 A1, with PCT filed 19 February, 2020), as applied to claim 22 above, and further in view of Colvin (US 5,422,276 A).
Regarding claim 28, Kato teaches a method according to claim 22. Kato discusses how the management system (100) can analyze and present the collected data to help identify trends and guide a user to more effective use of the sterilizer ([0048]-[0050]; management system 100 can warn a user when a combination of sets and placement positions is determined not to be used in order to keep a quality of the sterilization process at a high level—[0055]). Kato does not particularly disclose a step of using a neural network to obtain an improved result from at least one data set.
However, in the analogous art of sterilizer test methods (title, abstract), Colvin teaches a neural network which can learn of its own accord from a dynamic system to provide better reference values (column 16, lines 14-22, especially lines 20-22), wherein the neural network is trained in an adaptive process by receiving test results and associated data from a data base (column 16, lines 20-54). Therefore, it would be obvious to a person having ordinary skill in the art to input data from the management system of Kato into a neural network, as similarly seen in Colvin, for the benefit of training the neural network to identify better operating or reference parameters which can be employed to yield an improved disinfecting effect.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Kitamura (US 2022/0226529 A1), as applied to claim 31 above, in view of Hughes (US 6,051,187 A).
Regarding claim 36, Kitamura teaches the substrate according to any of claim 31. Kitamura does not clearly teach the substrate further comprises at least one aperture configured to provide visual access to the sensor patch.
However, in the analogous art of monitoring systems for sterilization processes (title, abstract), Hughes teaches a sterilization test pack (10) including a test pack insert (20; see Fig. 2) which comprises a substrate (thick stack of textile fabric 22) which defines a hole (inner chamber or well 24) (column 2, lines 50-59) that receives a chemical indicator (28) (column 3, lines 1-3) substantially configured as a patch (Figs. 5, 10), wherein the chemical indicator can be seen via the hole (Fig. 10) and the test pack is capable of being reused (column 3, lines 51-55). Therefore, it would be obvious to a person having ordinary skill in the art to try configuring the chemical indicator of Kitamura as a substrate including a hole for receiving and providing visual access to a sensor patch, as substantially seen in Hughes (column 2, lines 50-59, Figs. 2, 5 and 10), for the benefit of enabling reuse of the substrate in additional sterilization cycles (see Hughes at column 3, lines 51-55).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADY C PILSBURY whose telephone number is (571)272-8054. The examiner can normally be reached M-Th 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, MICHAEL MARCHESCHI can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRADY C PILSBURY/Examiner, Art Unit 1799
/JENNIFER WECKER/Primary Examiner, Art Unit 1797