DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, corresponding to claims 1-20 and 22 in the reply filed on September 15th, 2026 is acknowledged. Claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Interpretation
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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 denotes the limitation “a variable of the at least one indicator of the at least one indicator of the process challenge device” in line 8 to line 9. It appears “of the at least one indicator” is inadvertently written twice. Appropriate correction is required.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 5, 6 and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ludowise et al. (U.S. Publication No. 2019/0117810).
Concerning claims 1 & 20, it is first noted that the process challenge device (and the components therein; i.e., indicator(s)) are not positively recited in the claims. As such, the claims will be examined accordingly.
With respect to claims 1, 6 & 20, Ludowise discloses a digital autoreader for determining efficacy of a sterilization process, the digital autoreader comprising:
a housing (20) comprising an interior and an exterior;
a well (40) for receiving a process challenge device (25), the process challenge device comprising a first indicator and a second indicator (paragraph 32 & 54), the well comprising an opening and a block for retaining the process challenge device (Figures 2, 4 & 5; paragraphs 50-54), wherein the block is located within the interior of the housing (20) as shown in Figures 1-5 (paragraphs 32, 50 & 51);
A first sensor (85) located within the interior of the housing (20) and positioned adjacent to the block of the well (40), the first sensor (85) configured to read a variable of the first indicator of the process challenge device (25) and determine whether the process challenge device has been adequately sterilized (paragraphs 67-69);
a second sensor located within the interior of the housing (20) and positioned adjacent to the block of the well (40), the second sensor configured to read a variable of the second indicator and determine whether the process challenge device has been adequately sterilized (paragraph 72), wherein the second sensor must be necessarily located at a location different from where the first sensor (85) is located by the disclosure of a read sensor (85) and a further fluorescence detector in paragraph 72; and
An interface (50) to alert a user if the process challenge device has been adequately sterilized (paragraphs 52 & 53).
Concerning claim 2, Ludowise also discloses that the first indicator is capable of being a chemical indicator, wherein the first sensor comprises a chemical indicator reader (paragraphs 49-51).
Regarding claim 15, Ludowise continues to disclose that the digital autoreader comprises a plurality of wells (40) for receiving a plurality of process challenge devices (25) as set forth in paragraphs 53-55 (Figure 2).
With respect to claim 5, Ludowise further discloses that the at least one indicator is capable of comprising a biological indicator, wherein the first sensor comprises a biological indicator reader, wherein the biological indicator reader comprises a photodetector (i.e., fluorescence detector; paragraph 72).
Concerning claim 16, Ludowise also discloses that the interface (50) displays information corresponding to the process challenge device (25) inserted within the well (40) as set forth in paragraph 52.
With respect to claim 17, the reference further discloses that the interface comprises a tab (50) corresponding to the process challenge device (25) inserted within the well (40), the tab (50) comprising at least one of a result icon (green/red light) communicating whether the process challenge device has been adequately (paragraph 52).
Regarding claim 18, Ludowise discloses that the well (40) comprises a locating feature for correctly orienting the process challenge device (25) within the well (paragraphs 57-59).
Concerning claim 19, the reference also discloses that the indicator is capable of comprising a biological indicator, wherein said biological indicator is capable of comprising a gas and/or conductivity sensor (paragraph 54).
Claims 1, 5, 7-11, 14 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pederson et al. (U.S. Publication No. 2013/0217107).
Concerning claims 1, 5 & 22, Pederson discloses a system for determining efficacy of a sterilization process, the system comprising:
An integrated process challenge device (100) comprising:
A shell comprising an interior and an exterior (paragraph 50; Figure 2);
A compartment (103) defined by the interior and exterior of the shell (paragraph 50; Figure 2), the compartment shaped to retain a biological indicator (115/122); and
An opening (107) located on the exterior of the shell adjacent to the compartment (103), wherein the opening allows a sterilant to enter and exit the compartment (paragraphs 55 & 56); and
A digital autoreader that determines efficacy of the sterilization process, the digital autoreader comprising:
A housing comprising an interior and an exterior (Figures 1 & 3);
A well (14) for receiving the integrated process challenge device (100), the well comprising an opening and a block for retaining the integrated process challenge device (100), wherein the block is located within the interior of the housing (Figures 1 & 3);
A first sensor biological indicator reader photodetector (concerning claim 5; numerals 54/74; paragraph 201) located within the interior of the housing and positioned adjacent to the block of the well (Figures 3 & 4), the first sensor biological indicator reader configured to read a variable on the biological indicator of the integrated process challenge device and determine whether the integrated process challenge device has been adequately sterilized (paragraphs 183, 187, 188 and 201);
A crushing mechanism (130) located within the interior of the housing (Figures 3 & 4), and configured to crush a container (120) within the biological indicator in the process challenge device, the container having a growth medium housed therein (paragraphs 113 & 118-120); and
An interface (16) to alert a user if the integrated process challenge device has been adequately sterilized (paragraph 48).
Regarding claims 8 & 9, Pederson also discloses that the interior of the housing comprises a mixing mechanism (158/159) arranged adjacent to an end of the container (120) such that the mixing mechanism (158/159) can saturate a biological culture sample (115) of the process challenge device with the growth medium (122) when the container is crushed (paragraphs 118-123).
With respect to claim 10, Pederson further discloses that the interior of the housing comprises a heating element for incubating the biological culture sample and the growth medium at a desired temperature (paragraphs 175-178 & 183).
Concerning claim 11, Pederson also discloses that the first sensor biological indicator reader is configured to detect at least one of a volume of the growth medium contained within the container or a saturation level of a biological culture sample and the growth medium (paragraphs 135, 170, 171, 187, 197, 200 and 201).
Regarding claim 14, Pederson further discloses that the block of the well comprises a locking mechanism, the locking mechanism configured to selectively lock and release the process challenge device within the well (paragraph 166).
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.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ludowise et al. (U.S. Publication No. 2019/0117810) in view of Karasawa (U.S. Publication No. 2022/0027658).
Ludowise is relied upon as set forth above. Ludowise does not appear to disclose that the chemical indicator reader comprises a camera. Karasawa discloses a chemical indicator for determining the efficiency of a sterilization process (paragraph 25), wherein the chemical indicator (1) is provided in conjunction with an apparatus that includes a first sensing chemical indicator reader (110) as shown in Figures 1-4. The reference continues to disclose that the first sensing chemical indicator reader (110) includes a camera in order to simultaneously determine a status of the indicator while providing a visual image of said indicator for an operator to view (paragraphs 24, 28, 31 & 33). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a camera as the chemical indicator reader in Ludowise in order to simultaneously determine a status of the indicator while providing a visual image of said indicator for an operator to view as exemplified by Karasawa.
Thus, claim 3 is not patentable over Ludowise in view of Karawasa.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ludowise et al. (U.S. Publication No. 2019/0117810) in view of Corsini (U.S. Publication No. 2020/0030476).
Ludowise is relied upon as set forth above. Ludowise does not appear to disclose that the digital autoreader comprises a processor comprising a machine learning algorithm programmed therein, the machine learning algorithm configured to read an output of the at least one indicator and determine if a change in an appearance of the at least one indicator indicates that the process challenge device has been adequately sterilized. Corsini discloses a digital autoreader for determining efficacy of a sterilization process, wherein the autoreader comprises a first sensing indicator reader (140) for receiving a process challenge device that includes a chemical indicator (Abstract; paragraph 102). The reference continues to disclose that the digital autoreader comprises a processor comprising a machine learning algorithm programmed therein, the machine learning algorithm configured to read an output of the at least one indicator and determine if a change in an appearance of the at least one indicator indicates that the process challenge device has been adequately sterilized in order to prevent erroneous inspections of the chemical indicator by an operator (paragraph 127). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the autoreader of Ludowise with a processor comprising a machine learning algorithm programmed therein, the machine learning algorithm configured to read an output of the at least one indicator and determine if a change in an appearance of the at least one indicator indicates that the process challenge device has been adequately sterilized in order to prevent erroneous inspections of the chemical indicator by an operator as exemplified by Corsini.
Thus, claim 4 is not patentable over Ludowise in view of Corsini.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ludowise et al. (U.S. Publication No. 2019/0117810) in view of Thompson et al. (U.S. Publication No. 2017/0252474).
Ludowise is relied upon as set forth above. Ludowise does not appear to disclose a barcode or QR code scanner mounted on the exterior of the housing (20). Thompson discloses a digital autoreader for determining efficacy of a sterilization process, wherein said reader comprises a housing (102), in which a process challenge device comprising an indicator is placed therein in order to determine said efficacy of said sterilization process (paragraphs 75 & 76). The reference continues to disclose a barcode or QR code scanner mounted on the exterior of the housing (102) in order to connect the housing via wireless communications with the associated sterilizer utilized, and other user displays for information sharing (paragraph 208). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a barcode or QR code scanner mounted on the exterior of the housing of Ludowise in order to connect the housing via wireless communications with the associated sterilizer utilized, and other user displays for information sharing as exemplified by Thompson.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN C JOYNER whose telephone number is (571)272-2709. The examiner can normally be reached Monday-Friday 8:00AM-4:30PM.
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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.
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/KEVIN JOYNER/Primary Examiner, Art Unit 1799
