Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
As stated in the previous action, the definitions for certain terms appearing in the claims set forth within the instant specification at paragraphs [0062] through [0074], paragraph [0091], and paragraph [0102], are acknowledged. Generally, the definitions set forth correspond to the broadest reasonable interpretation of the claim language and the definitions have been applied to interpret the claims. Of particular note is that that paragraph [0062] defines the terms “about” and “approximately” as encompassing a range of ±5% of a stated value.
Response to Amendment
Claims 1-2, 22, 33-34, and 41 are amended. Claims 3-7, 9, 11-12, 15-16, 18, 21, 23, 27, 29-31, 35-40, and 43-44 are cancelled. Claims 1-2, 8, 10, 13-14, 17, 19-20, 22, 24-26, 28, 32-34, 41-42, and 45 are pending and have been fully considered.
The previously set forth objection to claim 22 is withdrawn in view of the amendment to the claim.
Response to Arguments
Applicant’s arguments filed 23 January, 2026, with respect to the previously set forth rejections under 35 U.S.C. 102 and 103 have been fully considered and are persuasive insofar as the relied upon primary reference, Cregger et al. (US 2019/0106726), does not teach a plurality of indicator compartments comprising a biological indicator, as required by independent claim 1 as amended. Instead, as noted by the applicant, Cregger teaches a single indicator compartment comprising a biological indicator (see applicants response filed 23 January, 2026, at pages 7-8). Accordingly, the previously set forth rejections under 35 U.S.C. 102 which rely upon Cregger are withdrawn because Cregger alone does not teach all limitations of claim 1. All other rejections under 35 U.S.C. 103 which rely on Cregger as a primary reference as previously set forth are similarly withdrawn in view of the amended scope of the claims.
However, the examiner does not agree with the applicant’s assessment that: “Nothing in the Cregger or Bommarito disclosures teach or suggest using multiple biologic al indicators and there is no identifiable reason that nay skilled artisan would be motived by the disclosures to include more than one biological indicator into a sterilization monitoring device, as presently claimed (applicant’s response at page 8, second to last paragraph). In contrast to the applicant’s assertion, Bommarito clearly discloses at Fig. 2 and paragraph [0017] a plurality of biological indicators (58,60,62) displaced along a fluid pathway (56) of a device (50), and from Fig. 3 of Bommarito it is evident that a plurality of compartments are defined in a layer (53) of the device (50) for receiving the biological indicators and chemical indicators (64,68) ([0018]).
In view of the above, a new grounds of rejection is set forth below which relies on Bommarito as a primary reference because it better encompasses the scope of the claims as amended. The new grounds of rejection are necessitated by the amendments to the claims.
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, 8, 10, 14, 24-25, 28 and 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bommarito (US 2018/0071418 A1).
Initially, it is noted that Bommarito has a common Assignee/Applicant (3M Innovative Properties Company) with the instant application; accordingly, it would appear that the exception under 35 U.S.C. 102(b)(2)(C) applies, and Bommarito is not eligible art under 35 U.S.C. 102(a)(2). However, Bommarito remains eligible art under 35 U.S.C. 102(a)(1), and cannot be excepted under any of the 35 U.S.C. 102(b)(1) exceptions because Bommarito was published (15 March, 2018) over one year before the effective filing date (12 August, 2020) of the instant application.
Regarding claim 1, Bommarito teaches a process challenge device comprising integrated chemical and biological indicators (abstract), wherein an embodiment of the device (50) comprises a plurality of biological indicators (58,60,62) and chemical indicators (64,68) arranged within compartments formed in a layer (53) of the device and along a flow path (microfluidic channel 56) of the device, as seen in Figs. 2-3 below ([0017]-[0018]).
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Accordingly, Bommarito teaches a sterilization monitoring device (indicator device 50) comprising:
a flow channel (microfluidic channel 56) comprising an entry port (fluid inlet 52) for receiving a sterilant (connection port 52 at one end of the channel 56 allows attachment of the device 50 directly to an endoscope reprocessor…and disinfectant continuously flows through microfluidic channel during a cycle—[0019]; thus evident that inlet 52 receives sterilant from reprocessor during use), and
a plurality of indicator compartments (see Fig. 3, a plurality of compartments are defined in layer 53 for receiving indicators, e.g., 60 and 64—[0018]; device contains test chamber holding a chemical indicator and a biological indicator—[0019]),
more than one indicator compartment comprising a biological indicator (numerous biological indicators 58,60,62—Fig. 2, [0017]; from Figs. 2-3, it is evident that each biological indicator is contained in a corresponding compartment defined within layer 53), and
each indicator compartment being in fluid communication with the flow channel (chemical 64,68 and biological 58,60,62 are disposed along length of channel—Fig. 2, [0017]—which clearly implies fluid communication of each indicator compartment with the flow channel 56; also in support of the finding, Bommarito indicates in a related embodiment that a channel 14 is in fluid communication with indicator devices 16,18 along its path—[0016]); and
a shell (layers 51,53) encasing the challenge network such that access to the plurality of indicator compartments is only through the flow channel (indicators, e.g. 64 and 60, are disposed in a layer 53 and the microfluidic channel may be disposed in a layer 51—[0018]; viewing Figs. 2-3, it is evident that the layers are configured so that a fluid can only reach the compartments via the channel 56 to mimic the flow conditions of an endoscope—consider [0015] and [0021] indicating the device channel mimics the challenge posed by an endoscope; accordingly, the layers 51,53 fairly define a shell encasing the challenge network).
Regarding claim 8, Bommarito discloses the sterilization indicator device of claim 1. Claim 8 requires that the flow channel of the device be characterized by one or more of: a length of 10mm to 800 mm; a maximum cross-sectional width of 0.125 mm to 20 mm, wherein the width is uniform or non-uniform along a length of the flow channel; and a maximum cross-sectional height of about 0.05 mm to about 25 mm, wherein the height is uniform or non-uniform along a length of the flow channel.
In an exemplary embodiment, Bommarito indicates that a channel width/height (diameter) of 1 mm can be suitable ([0023]); thus, Bommarito is sufficient to teach one or more of the recited limitations (i.e. a width between 0.125 mm and 20 mm, and/or a height of 0.05 mm to 25 mm) and therefore anticipates claim 8.
Furthermore, to address potential future amendments to claim 8, it is emphasized that Bommarito teaches that the channel (56) of the indicator device (50) is designed with an arcuate path dimensioned to mimic the resistance a sterilant would experience when penetrating inner portions of a target object for sterilization, particularly an endoscope ([0021]). Bommarito indicates that such design can be accomplished based on Poiseuille’s law, which establishes that resistance is greater when a channel is longer and narrower (see [0022], equation shows that resistance “R” is proportional to channel length L and inversely proportional to the channel radius). From the teachings of Bommarito, it is evident that the selection of channel diameter (or length and width) and channel length is a matter of design choice that should be optimized for the benefit of mimicking the flow conditions that a sterilant would experience when penetrating the inner surfaces of an object to be sterilized; a device configured as such would provide more accurate indications of the sterility status of the objects targeted for sterilization. These findings are sufficient to establish the obviousness of all of a channel length in the range of about 10 mm to about 800 mm, a maximum cross-sectional width within the range of 0.125 mm to about 20 mm, and a maximum cross-sectional height of about 0.05 mm to about 25 mm, by way of routine optimization of the channel dimensions for the benefit of achieving a desired resistance to flow through the channels which mimics the resistance to flow the sterilant experiences when penetrating a target object to be sterilized (see Bommarito at [0022]-[0023]).
Regarding claim 10, Bommarito teaches the device of claim 1. As discussed with respect to claim 8 above, Bommarito teaches an exemplary embodiment of the device wherein the flow channel has a diameter of 1 mm ([0023]), which corresponds to a hydraulic radius of 0.25 mm (hydraulic radius is cross sectional area divided by the perimeter of the cross section—see instant specification at [0068]; Bommarito disclosing a “diameter” at [0023] fairly implies a circular cross section; a circular cross section will have a hydraulic radius equal to one fourth of the diameter for a circular cross section). Thus, Bommarito teaches that the flow channel has a hydraulic radius within the claimed range of about 0.025 mm to about 12.5 mm. Also, the hydraulic radius of the channel necessarily must be at least one of uniform or non-uniform along a length of the flow channel because the recited groups are collectively exhaustive (a channel dimension can only be uniform or non-uniform along its length).
In view of the above, Bommarito anticipates claim 10. It is also noted that, absent persuasive evidence of significance, future amendments directed toward the hydraulic radius or geometry of the flow channel would likely be obvious for similar reasons as discussed with respect to claim 8; that is, Bommarito establishes the obviousness of the routine optimization of the channel dimensions for the benefit of achieving a resistance to flow which mimics the resistance to flow experienced by a sterilant as it penetrates the inner surfaces of a target item to be disinfected (see Bommarito at [0022]-[0023]).
Regarding claim 14, Bommarito teaches the sterilization monitoring device of claim 1. Claim 14 indicates that the device further comprises one or more sub-flow channel extending from the flow channel, and the instant specification at [0067] indicates that a sub-flow channel refers to any path extending from a longest path within a challenge network. As seen in Fig. 2, Bommarito teaches a plurality of pathways (58b, 60b, 62b) which substantially extend out form the main flow channel (56) (Fig. 2, [0017]); accordingly, Bommarito fairly teaches one or more sub-flow channels (58b,60b,62b) extending from the flow channel (56).
Regarding claim 24, Bommarito teaches the sterilization monitoring device of claim 1. Bommarito further teaches one or more indicator compartments comprising a chemical indictor (numerous chemical indicators 64 and 68—Fig. 2, [0017]; chemical indicator 64 disposed in layer 53 of layer 53—[0018]; Fig. 3 shows how a compartment is defined in layer 53 for receiving chemical indicator 64), selected from a coloring-changing dye, a color-changing pigment, a metal sulfide precursor, a metal complex or salt, a fluorescent molecular switch, and a combination thereof (when the concentration of ortho-phthalaldehyde is sufficient, the local pH typically rises above 11 and a color change to a deep purple occurs…there are several suitable pH dyes that can be used in this indication—[0024]).
Regarding claim 25, Bommarito teaches the sterilization monitoring device of claim 1. Bommarito further teaches at least one medium compartment (growth media capsules 58a,60a,62a) comprising a medium selected from a nutrient medium, a fluorogenic medium, a pH indicator medium, and a combination thereof, wherein the medium compartment is in fluid communication with one or more indicator compartment (58,60,62) (each biological indicator 58,60,62 is coupled with corresponding growth media capsules 58a,60a,62a, with pathways 58b,60b,62b providing fluid communication with the biological indicators once a frangible member of the growth media capsules are fractured—[0017]).
Regarding claim 28, Bommarito teaches the sterilization monitoring device of claim 25. Bommarito further teaches at least one removable barrier (frangible member) separating the at least one medium compartment from the one or more indicator compartment (fluid pathways 58b,60b,62b provide fluid communication with the biological indicators 58,60,62 once a frangible member of the growth media capsules 58a,60a,62a are fractured—Fig. 2, [0017]; breaking the frangible member fairly constitutes removing a barrier to fluid communication between the medium compartment and indicator compartment).
Regarding claim 33, Bommarito teaches a method for evaluating a sterilization process (use of biological indicators integrated within a process challenge device for an automated endoscope reprocessor—abstract; also see claim 6), the method comprising:
providing a sterilization monitoring device of claim 1 (device 50—see rejection of claim 1 above; a user connects the device 50 to the automated endoscope reprocessing [AER] machine—[0020])
exposing the sterilization monitoring device to conditions set forth in a sterilization protocol (device 50 placed in basin of AER so that it is fully immersed in disinfectant during the cycle—[0020]; disinfectant flows through device 50 over the entire cycle—[0019];;
allowing a sterilant to contact the sterilization monitoring device at a temperature for a period (device 50 placed in AER so it is immersed in disinfectant—[0020]; disinfectant flows through device 50 over the entire cycle; disinfection cycle defined by a time and temperature—[0029]; time and temperature information—[0004]; thus evident that the disclosed use of the device 50 includes contacting the device with a sterilant for a temperature and time defined by the disinfection cycle of the AER)
inspecting one or more biological indicators for a change in one or more of color, pH, and fluorescence, comparing the change in one or more of color, pH, and fluorescence with a sterilization threshold value, and determining whether or not the change in one or more of color, pH, and fluorescence indicates a satisfactory sterilization in view of the sterilization threshold value (analyzing the indicator to confirm whether desired process conditions have bene met—[0011], claim 6; the pass/fail determination may then be based on how quickly the fluorescent intensity reached a given level. It would also be possible to use colorimetric assays instead of fluorescence based assays—[0025]; thus, Bommarito teaches determining if the disinfection cycle was satisfactory [pass] or not [fail] based on a comparison of a fluorescence of the biological indicator to a threshold [“given level”]).
Regarding claim 34, Bommarito teaches the method of claim 33. Bommarito further teaches contacting one or more biological indicators with a nutrient medium prior to the inspecting (biological indicators exposed to growth media once a frangible member of growth media capsules are fractured—[0017]; activate the biological indicator by breaking a frangible vial containing the growth media allowing media to enter the chamber holding the indicator—[0020]; also see [0025]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 17, 19, and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Bommarito (US 2018/0071418 A1).
Regarding claim 2, Bommarito teaches a sterilization monitoring device (indicator device 50—[0017]-[0018]) comprising:
a challenge network, comprising:
a flow channel (56) comprising an entry port (52) for receiving a sterilant (connection port 52 at one end of the channel 56 allows attachment of the device 50 directly to an endoscope reprocessor…and disinfectant continuously flows through microfluidic channel during a cycle—[0019]; thus evident that inlet 52 receives sterilant from reprocessor during use), and
more than one indicator compartment comprising a biological indicator (numerous biological indicators 58,60,62 displaced along length of channel 56—[0017]; biological indicators disposed in layer 53—[0018]; from Fig. 3, it is evident compartments are defined in layer 53 for receiving the indicators)
at least one medium compartment comprising a nutrient medium (each biological indicator coupled with corresponding growth media capsules 58a, 60a, 62a—Fig. 2, [0017]),
wherein the medium compartment is in fluid communication with one or more indicator compartment (pathways 58b, 60b, 62b provide fluid communication with biological indicators 58, 60, 62, once a frangible member of the growth media capsules are fractured—[0017]); and
a shell encasing the challenge network such that access to the one or more indicator compartment is only through the flow channel (layers 51 and 53 encase challenge network, which is designed to mimic an endoscope, and access to indicators is only through channel 56—see Figs. 2-3, [0015], and [0018]).
The cited embodiment (50; Figs. 2-3) of Bommarito does not clearly teach the device comprising a plurality of challenge networks, as recited in claim 1, the shell encasing the plurality of challenge networks.
However, it is first noted that generally, the duplication of parts is prima facie obvious absent evidence of a new or unexpected result; see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) as cited in MPEP 2144.04(VI.)(B.). Furthermore, Bommarito explicitly suggest embodiments wherein a single device includes multiple channel lengths to mimic different types of endoscopes (In addition to the embodiments described above, other form factors may be contemplated for the application taught in the current disclosure. For example, multiple channel lengths could be built on a single card to mimic different types of endoscopes—[0026]; also see [0027] discussing how multiple indicators can be disposed along a channel path, and [0028] discussing how indicators may be positioned in dead volumes formed with respect to the flow channel to mimic dead flow ends in endoscopes). Therefore, it would be obvious to a person having ordinary skill in the art to modify the device of Bommarito to include a plurality of challenge networks (i.e., to duplicate at least the inlet 52, microchannel 56, and biological indicators 58,60,62 of Bommarito, while modifying the duplicated channel geometry) encased by the shell for the expected benefit of allowing the device to mimic the challenge posed by different types of endoscopes (see Bommarito at [0026]-[0028]).
Regarding claim 17, Bommarito teaches the sterilization monitoring device of claim 14. Claim 17 requires that the sub-flow channel be characterized by one or more of: a length of about 2 mm to about 200 mm, a maximum width at any point of about 0.125 mm to about 20 mm, wherein the width is uniform or non-uniform along the length of the sub-flow channel, and a height at any point of about 0.05 mm to about 25 mm, wherein the height is uniform or non-uniform along the length of the sub-flow channel. Bommarito does not particularly discuss the dimensions of the sub flow channels (58b,60b,62b). However, Bommarito does indicate that the flow channel can have an exemplary diameter of 1 mm ([0023]), and that the flow channel can be dimensioned to achieve a desired resistance to flow ([0021]-[0022]). While these teachings are not particular to the sub-flow channel of Bommarito, they do reasonably imply that the sub-flow channels of Bommarito have dimensions on the millimeter scale and suggest that the sub-flow channels should be dimensioned to achieve appropriate flow conditions. Therefore, it would be obvious to a person having ordinary skill in the art to configure the sub-flow channel of Bommarito to have at least one of: a length of about 2 mm to about 200 mm; a maximum width at any point of about 0.125 mm to about 20 mm, wherein the width is uniform or non-uniform along the length of the sub-flow channel; and a height at any point of about 0.05 mm to about 25 mm, wherein the height is uniform or non-uniform along the length of the sub-flow channel. Such modification would be accomplished by routine optimization of the sub-flow channel dimensions for the benefit of achieving a desired flow of growth media from the capsules (58a,60a,62a) to the biological indicators (58,60,62) (consider Bommarito at [0017] and [0021]-[0023]).
Regarding claim 19, Bommarito teaches the sterilization monitoring device of claim 1. Bommarito does not indicate the volume of each compartment, and thus does not teach each indicator compartment independently having a volume between about 0.25 cm3 and about 10 cm3. However, changes in size and proportion are prima facie obvious absent persuasive evidence of significance; see MPEP 2144.04(IV.)(A.). Furthermore, a person of ordinary skill in the art would recognize that the compartments of Bommarito should each be sized to fit at least one sterilization indicator and should allow for contact of a sterilant with the indicator. Accordingly, it would be obvious to a person having ordinary skill in the art to modify the device of Bommarito and arrive at a compartment volume within the claimed range of between about 0.25 cm.sup.3 and about 10 cm.sup.3 by way of routine optimization of the compartment size for the benefit of accommodating an indicator of a desired size and providing sufficient space for sterilant to flow into and/or around the indicator.
Regarding claim 41, the claim is directed to a kit which combines essentially combines the device of instant claim 1 with instructions for performing the method of claim 1. Accordingly, see the rejection of claim 1 above regarding how Bommarito teaches a sterilization monitoring device of claim 1, and see the rejection of claim 33 above regarding how Bommarito teaches steps for using the device comprising: exposing the sterilization monitoring device to conditions set forth in a sterilization protocol; allowing a sterilant to contact the sterilization monitoring device at a temperature for a period (device 50 positioned in AER and exposed to disinfectant during disinfectant cycle thereof, said cycle defined by a temperature and duration—see [0004], [0015], [0019]-[0020], and [0029]); inspecting one or more biological indicators for a change in one or more of color, pH, and fluorescence; comparing the change in one or more of color, pH, and fluorescence with a sterilization threshold value; and determine whether or not the change in one or more of color, pH, and fluorescence indicates a satisfactory sterilization in view of the sterilization threshold value (analyzing the indicator to confirm whether desired process conditions have bene met—[0011], claim 6; the pass/fail determination based on how quickly the fluorescent intensity reached a given level—[0025]).
Bommarito does not particularly suggest that the device is provided in combination with instructions directing a user to perform the steps outlined above.
However, it is first noted that providing a device with instructions for its use is standard (i.e., extremely common). Furthermore, nonfunctional printed matter does not distinguish a claimed product from an otherwise identical prior art product; see MPEP 2112.01(III.). Therefore, it would be obvious to a person having ordinary skill in the art to provide the sterilization monitoring device of Bommarito with instructions for use in accordance with claim 33 for the evident benefit of guiding a user to appropriately use the product for effective verification of a sterilization process.
Regarding claim 42, Bommarito teaches the kit of claim 41. Bommarito further teaches a container comprising nutrient medium (growth media capsules 58a,60a,62a—[0017]).
Claims 13, 26, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Bommarito (US 2018/0071418 A1) in view of Ahimou et al. (US 2015/0337354 A1).
Regarding claim 13, Bommarito teaches the sterilization monitoring device of claim 1. Bommarito indicates that the flow channel may be disposed in a layer (51) of material ([0018]). Bommarito does not clearly teach that the flow channel is comprised of a polyethylene terephthalate film and a silane-terminated polyurethane adhesive.
However, in the analogous art of biological indicator devices (title, abstract), Ahimou teaches a device (100) comprising a body (10) formed by attaching two layer (12, 16) with an adhesive (14), the device comprising microchambers (24) connected via passageways (20, 22) defined in at least one of the layers ([0050], Figs. 1-2). The microchambers (24) serve as indicator compartments for biological indicators (microchamber 24 houses test organisms 40—[0053]—and fluorescent sensors 45, 47—[0057], [0058]—which are used to detect if a test microorganism has survived as sterilization process—[0006]). Ahimou recognizes that polyethylene terephthalate (polyester) is a suitable material for the layers (12, 16) ([0076]), and that silane-terminated polyurethane adhesive (silicone polyurea adhesive—[0180], [0184]) is a an appropriate adhesive (14), wherein the materials should be selected with consideration for their ability to withstand compatibility with the conditions of a sterilization procedure and being non-toxic to the test microorganisms ([0076],[0081]). Therefore, it would be obvious to a person having ordinary skill int the art to modify the device of Bommarito such that the flow channels are formed using a polyethylene terephthalate film and a silane-terminated polyurethane adhesive, as seen in Ahimou, for the benefit of forming the channels with materials that can withstand the conditions of a sterilization procedure and which do not pose a toxicity risk to the test microorganisms (see Ahimou at [0076], [0081], and [0184]).
Regarding claim 26, Bommarito teaches the sterilization monitoring device of claim 1. Although Bommarito does teach a chamber containing a growth medium (growth media capsules 58a,60a,62a—[0017]) and a medium path (pathways 58b,60b,62b—[0017]), Bommarito does not clearly teach a medium port for receiving a medium selected from a nutrient medium, a fluorogenic medium, a pH indicator medium, and a combination thereof, and a medium path, wherein one or more indicator compartment is in fluid communication with the medium port via the medium path.
However, Ahimou teaches the analogous device discussed above (see rejection of claim 13 above), including embodiments wherein a liquid growth medium is supplied to indicator compartments (24) by supplying the medium to a port (opening 18 of liquid receiving chamber 30) connected to the compartments by channels (20, 22) (Fig. 1, [0050]: The at least one opening 18 opens into a liquid-receiving chamber 30, which is in fluidic communication with the microchamber 24 via a primary passageway 20. The opening 18 is dimensioned to permit the access of a liquid transfer device, e.g., a pipet tip or a needle, thereby allowing the introduction of fluid into the fluid-receiving chamber; liquid includes a nutrient medium for the test microorganisms—[0072]; liquid introduced through opening 18 is a nutrient medium—see [0100]). The arrangement allows for the nutrient medium to be supplied to multiple biological indicators substantially simultaneously (consider Fig. 1, [0072], [0100]), reducing the amount of manipulation required to incubate each biological indicator (Bommarito would require fracturing of each capsules 58a,60a,62a individually –consider Figs. 2, [0017]).
Therefore, it would be obvious to a person having ordinary skill in the art to reconfigure the device of Bommarito in view of Ahimou such that the device includes a medium port connected to the biological indicator compartments through medium paths, as seen in Ahimou, for the benefit of facilitating the incubation of biological indicators by allowing nutrient broth to be introduced to the indicator compartments through the port and channels without the need to physically manipulate the biologic indicator (see comparison of Ahimou and Bommarito discussed at the end of the immediately above paragraph).
Regarding claim 45, Bommarito teaches the kit of claim 41. Although Bommarito does teach a chamber containing a growth medium (growth media capsules 58a,60a,62a—[0017]) and a medium path (pathways 58b,60b,62b—[0017]), Bommarito does not clearly teach a medium packet comprising said nutrient medium, which is configured to mate with the sterilization monitoring device in order to dispense the medium into the sterilization monitoring device.
However, as discussed with respect to claim 26 above, Ahimou teaches an analogous sterilization challenge device (100) wherein a nutrient medium is supplied to a biological indicator compartment (24) by injecting the medium into a port (18) of the device which is fluidically connected to the biological indicator via channels (20,22) (see Ahimou at Fig. 1, [0050], [0072] and [0100]). The medium is injected by a liquid transfer device, such as a pipet tip or a needle (opening 18 is dimensioned to permit the access of a liquid transfer device, for example a pipet tip or a needle—[0050]). Such a liquid transfer device fairly defines a medium packet configured to mate with the sterilization monitoring device in order to dispense the medium into the sterilization monitoring device. As discussed with respect to claim 26 above, the configuration of Ahimou allows for nutrient broth to be delivered to multiple biological indicators for incubation without requiring potentially tedious manipulation or removal of the biological indicators from the device (see rejection of claim 26 above).
Therefore, it would be obvious to a person having ordinary skill in the art to further modify the device of Bommarito such that the device is configured with a port fluidically connected to the indicator compartments through channels, and such that the device is provided in the kit alongside a liquid transfer device comprising a packet of nutrient medium configured for dispensing into the port (as seen in Ahimou) for the benefit of facilitating the incubation of the indicators without necessitating the removal or mechanical manipulation of the indicators (see discussion of Ahimou above).
Claims 20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bommarito (US 2018/0071418 A1) in view of Cregger et al. (US 2019/0106726 A1).
Regarding claim 20, Bommarito teaches the sterilization monitoring device of claim 1. Bommarito teaches the indicator being a biological indicator, a chemical indicator, or combination thereof (numerous chemical 64,68 and biological indicators 58,60,62—[0017]). Bommarito also fairly teaches that the indicator provides an indication of exposure to a disinfectant (chemical indicator monitors the minimum effective concentration of the disinfectant—[0019]; chemical indicators verify a minimum effective concentration of a disinfectant liquid—[0024]), with ortho-phthalaldehyde and glutaraldehyde contemplated as exemplary disinfectants ([0024]). Bommarito does not particularly suggest that the indicator is one of a steam indicator, an ethylene oxide indicator, or a hydrogen peroxide indicator.
However, in the analogous art of test packs for assessing sterilization ([0052]), Cregger teaches a test pack comprising compartments (220, 230) which receive a chemical indicator (280) and a biological indicator (SCBI 100) which are exposed to a flow of sterilant during a sterilization process ([0052]), wherein the sterilant is one of hydrogen peroxide, ethylene oxide, or steam (sterilant is hydrogen peroxide vapor, ethylene oxide, or steam—[0056], claim 21), and the chemical undergoes a change in color after it has been exposed to a sufficient quantity of sterilant ([0052]). Therefore, it would be obvious to a person having ordinary skill in the art to configure the device of Bommarito such that at least one of the indicators is a chemical indicator that reacts in response to steam, ethylene oxide, or hydrogen peroxide (i.e., a steam indicator, an ethylene oxide indicator, or a hydrogen peroxide indicator), for the benefit of adapting the device to provide an indication that a sufficient quantity of such a vapor sterilant (steam, ethylene oxide, or hydrogen peroxide) has been delivered during a sterilization process (see Cregger at [0052], [0056]).
Regarding claim 22, Bommarito teaches the sterilization monitoring device claim 1. Bommarito teaches that biological indicator can operate in a manner consistent with conventional biological indictors, comprising shelf stable spores of microorganisms which have their growth triggered by incubating in a growth medium ([0025]; [0020]). Bommarito does not teach that the spores are selected from Geobacillus stearothermophilus spores, Bacillus atrophaeus spores, Aspergillus niger, Bacillus subtilis, Clostridium spp., Bacillus subtilis var. niger, and a combination thereof.
However, in the analogous art of test packs for assessing sterilization ([0052]), Cregger teaches biological indicators (100) with test organisms including Geobacillus stearothermophilus spores, Bacillus atrophaeus spores, Clostridium spp., Bacillus subtilis , and combinations thereof (biological indicator 100 includes a carrier 190 inoculated with spores of the test organism—[0048]-[0049]; the spores may comprise spores of Geobacillus stearothermophilus, Bacillus atrophaeus…Clostridium sporogenes…Bacillus subtilis…or a mixture of two or more thereof—[0043]). Therefore, it would be obvious to a person having ordinary skill in the art to provide the biological indicator of the device of Bommarito with spores of at least one of Geobacillus stearothermophilus spores, Bacillus atrophaeus spores, Clostridium spp. and Bacillus subtilis, as seen in Cregger ([0043]; [0048]-[0049]) for the benefit of selecting an appropriate test organisms for determining whether a sterilization process is effective (consider Cregger at [0047]).
Claim 32 is rejected under 35 U.S as being unpatentable over Bommarito (US 2018/0071418 A1) in view of Witcher et al. (US 7,045,343 B2).
Regarding claim 32, Bommarito teaches the sterilization monitoring device of claim 1. Bommarito does not clearly teach a package that is at least partly permeable to the sterilant, wherein the package at least partly surrounds the shell.
However, in the analogous art of sterilization indicator test packs (title), Witcher suggests providing a sterilization challenge test pack including a sterilization indicator within a tray well inside of a sterilant penetrable material, such as Tyvek™, to enhance a resistance encountered by the sterilant (column 18, lines 12-25). Therefore, it would be obvious to a person having ordinary skill in the art to provide the device of Bommarito (including the shell thereof) in a Tyvek packaging material for the benefit of increasing the resistance to flow encountered by a sterilant entering the test device, when desired (see Witcher at column 18, lines 12-25).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRADY C PILSBURY/Examiner, Art Unit 1799
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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