Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submissions filed on 25 June, 2026 (comprising a request for continued examination), and 08 June, 2026 (comprising claim amendments and applicant’s arguments) have been entered.
Claim Interpretation
As stated in previous actions, the definitions of certain terms appearing in the claims are set forth within the instant specification at paragraphs [0062] through [0074], paragraph [0091], and paragraph [0102]. Generally, the definitions set forth correspond to the broadest reasonable interpretation of the claim language and the definitions have been applied when interpreting 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.
As amended, claims 19-20 depend from claim 2 and refer to “each of the more than one indicator compartments”. It is understood that claim 2 requires at least two (“a plurality of”) challenge networks, and each challenge network includes at least two (“more than one”) indicator compartments each housing (comprising) a biological indicator, such that the device requires a minimum of four indicator compartments each equipped with a biological indicator. When claims 19-20 refer to “each of the more than one indicator compartment”, it is understood that the limitations refer to each and every indicator compartment equipped with a biological indicator within the device.
Also, the language of “more than one indicator compartment” in claim 2 might be improved if the limitation is adapted—based on the language of claim 1—to recite “a plurality of indicator compartments, more than one indicator compartment of the plurality of indicator compartments comprising a biological indicator”, with dependent claims adjusted accordingly. However, no formal objection is set forth, and this matter is left at the discretion of the applicant.
Response to Amendment
Claims 1-2, 8, 10, 13-14, 17, 19-20, 22, 24-26, 28, 32-34, and 41-42 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.
Response to Arguments
Applicant’s arguments filed 08 June, 2026, with respect to the previously set forth rejections of the claims under 35 U.S.C. 102 and 103 have been fully considered.
With respect to the rejection of independent claim 1 under 35 U.S.C. 102, the applicant argues that the cited reference, Bommarito (US 2018/0071418 A1), does not teach that the sterilization monitoring device is configured to indicate a degree of sterilization for a given sterilization protocol based upon a number of the plurality of indicator compartments within the challenge network having indicators influenced by the sterilant at or above a sterilization threshold, as required by claim 1 as amended.
The examiner disagrees. It is acknowledged that the disclosure of Bommarito does not directly state that the number of indicators which reach a sterilization threshold value is an indication of a degree of sterilization achieved during a sterilization protocol.
However, as indicated in the previously set forth rejections, Bommarito does teach 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 ([0019]), 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]; each biological indicator is contained in a corresponding compartment defined within layer 53—see Figs. 2-3), and each indicator compartment being in fluid communication with the flow channel (chemical 64,68 and biological 58,60,62 indicators are disposed along length of channel 56—Fig. 2, [0017]) 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—see [0015] and [0021]).
Furthermore, Bommarito indicates that each biological indicator is analyzed and a parameter thereof is compared to a threshold value to determine if a sterilization procedure passed or failed at the location of the indicator (That difference in the spore population pre and post disinfection could then be compared to an expected difference for an effective cycle, and within a certain tolerance window, a determination could be made on whether the disinfection cycle was effective or not (pass or fail)… [alternatively] the pass/fail determination may then be based on how quickly the fluorescent intensity reached a given level—[0025]). Also, Bommarito teaches the device comprising multiple biological indicators (biological indicators 58, 60, 62—Fig. 2, [0017]) which can represent different challenges (the device could have multiple biological and chemical indicators disposed within the channel path to indicate multiple challenges simultaneously—[0027]; the device could be designed so that the microfluidic channel also included dead volumes either above or below the plane of flow as well as within that plane, to simulate valves and other dead flow ends common to the design of many flexible endoscopes. Indicators could be disposed at these locations to verify that an appropriate cycle was completed—[0028]). Accordingly, it is evident that when all of the biological indicators indicate a pass, all sterilization challenges are passed and a higher degree of sterilization has been achieved. Conversely, when fewer biological indicators indicate a pass, not all sterilization challenges have been passed and a lower degree of sterilization was achieved. Therefore, the device of Bommarito is reasonably configured to indicate a degree of sterilization for a given sterilization protocol based upon a number of the plurality of indicator compartments within the challenge network having indicators influenced by the sterilant at or above a sterilization threshold (more indicators achieving a threshold “pass” value in Bommarito fairly corresponds to a greater degree of sterilization).
In view of the above, the examiner holds that applicant’s argument with respect to claim 1 is not persuasive because the device of Bommarito meets all limitations of claim 1, there being no patentably distinct structural difference between the configuration of the claimed device and the disclosed configurations of the device of Bommarito. The previously set forth rejection of claim 1 under 35 U.S.C. 102 has been adjusted to address the amendment to claim 1, incorporating the teachings of Bommarito discussed above.
Additionally, a new ground of rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Ahimou et al. (US 2015/0337354 A1) is set forth below to emphasize the lack of novelty of claim 1 as amended.
With respect to the rejection of independent claim 2 under 35 U.S.C. 103, the applicant argues that the cited reference—Bommarito (US 2018/0071418 A1)—does not provide sufficient support or motivation for duplicating the challenge networks thereof to arrive at the claimed sterilization monitoring device, and the applicant alleges that the proposed modification is contrary to the purpose of Bommarito.
The examiner disagrees. At paragraph [0026], Bommarito suggests that “multiple channel lengths could be built on a single card to mimic different types of endoscopes”. Accordingly, the applicant’s allegation that “Bommarito’s entire design rationale is directed to replicating a single tortuous lumen geometry, the internal channel of an endoscope, to evaluate whether a reprocessing cycle can sterilize that specific geometry” (applicant’s response filed 08 June, 2026, page 11, final paragraph, lines 1-3) is directly contradicted by Bommarito at [0026] suggesting mimicking different types of endoscopes on a single card. Furthermore, following the suggestion of Bommarito would reasonably yield at least a single casing (single card) comprising multiple flow channels of different lengths. Bommarito also suggests that multiple biological indicators can be positioned at different locations along a channel length ([0017], [0027]), especially at locations which simulate valves or other dead zones of an endoscope ([0028]). Also, Bommarito teaches each biological indicator being in communication with a nutrient medium compartment (each biologic al indicator 58, 60, 62, coupled with corresponding growth media capsules 58a, 60a, 62a—[0017]).
Accordingly, the examiner holds that the combined teachings of Bommarito are sufficient to guide a person of ordinary skill in the art to arrive at a sterilization monitoring device comprising at least two challenge networks (multiple channel lengths—[0026]) within a single casing (built on a single card—[0026]), each challenge network including multiple biological indicators coupled to a nutrient medium compartments (consider [0017]), for the benefit of mimicking different types of endoscopes ([0026]) and different challenges along the lengths thereof ([0027]-[0028]) with a single device.
It is reiterated that the applicant’s allegation with respect to the “entire design rationale” of Bommarito is not supported by the explicit suggestiosn of Bommarito at paragraph [0026], as indicated above, and thus the proposed modification of Bommarito does not run contrary to the disclosure of Bommarito. Also, the examiner disagrees with the applicants assertion that Bommarito does not provide a reason to arrive at the claimed device (response at pages 11-12) because the suggestion of Bommarito to mimic different types of endoscopes and different challenges along the length thereof ([0026]-[0028]) provides sufficient reason for a person having ordinary skill in the art to include multiple biological indicators (and associated compartments) at multiple locations along challenge networks of different lengths, and to ensure each biological indicator is arranged to receive nutrient medium for proper functioning (see [0017], [0020], [0025]; biological indicator is exposed to growth media to determine if test microorganism thereof has been killed by sterilization process).
Furthermore, MPEP 2144.04(VI.)(B.) indicates that the duplication of parts has no patentable significance unless a new or unexpected result is produced; see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). In the instant case, the claimed invention encompasses the device of Bommarito wherein a process challenge network is duplicated within a single casing; as indicated above, the teachings of Bommarito reasonably guide a person of ordinary skill in the art toward such a design, and the applicant has not established that the duplication of the challenge network yields a new and unexpected result; therefore, the finding of obviousness with respect to claim 2 is further supported by MPEP 2144.04(VI.)(B.).
Therefore, the rejection of claim 2 under 35 U.S.C. 103 as being unpatentable over Bommarito is maintained below. Additionally, to emphasize the unpatentability of independent claim 2, a new rejection of claim 2 under 35 U.S.C. 102(a)(1) as being anticipated by Ahimou is further set forth below.
With respect to claims 8, 10, 14, 24-25, 28, and 33-34, the claims previously depended from claim 1 and have been adjusted to dependent form independent claim 2 as amended, with the applicant arguing for the novelty and non-obviousness of claims 8, 10, 14, 24-25, 28, and 33-34 essentially on the basis of their dependency on claim 2. Thus, examiner disagrees substantially on the same basis as indicated with respect to claim 2 above. Accordingly, the previously set forth rejections of claims 8, 10, 14, 24-25, 28, and 33-34 under 35 U.S.C. 102 are withdrawn and the claims are instead rejected under 35 U.S.C. 103 on similar grounds as previously set forth.
With respect to claims 41-42 and certain dependent claims (13, 20, 22, 25, 32, and 45), the applicant’s arguments rely on the presumption that Bommarito is insufficient to establish the obviousness of claim 2 (response at pages 13-14). As indicated above with respect to claim 2 above, the examiner disagrees. Therefore, the rejections of the linking and dependent claims under 35 U.S.C. 103 are maintained, with some minor adjustment to clarify aspects of the rejection and address amendments to the claims.
With respect to claims 17 and 19, the applicant indicates that the rejections rely on routine optimization and argues that it would not be obvious to a person having ordinary skill in the art to arrive at the arrived dimensions or volume (response at page 12). Particularly regarding claim 17, the applicant particularly notes that the sub-flow channels of Bommarito cited in the rejection are channels for the flow of growth media, whereas the only explicit indication of channel geometry in Bommarito is discussed with respect to the channel portions designed to present a challenge to the flow of sterilant.
In response, it is first noted that claim 17 requires a sub-flow channel with one of: a length between 2mm and 200 mm; a maximum width between 0.125 mm and 20mm, and a height between 0.05 mm and 25 mm. Claim 19 requires the indicator compartment has a volume between 0.25 cm3 and 10 cm3. MPEP 2144.04(IV.)(A.) discusses the obviousness of changes in size, with the court finding in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In the instant application, the applicant seeks to distinguish the device of claims 17 and 19 from Bommarito on the basis of the claimed device reciting a dimension not clearly disclosed by Bommarito. However, the applicant has not established if or how the recitation of the claimed dimensions would yield a device which performs differently from the prior art. Accordingly, there is sufficient grounds to maintain a finding of obviousness of claims 17 and 19 on the basis laid out in MPEP 2144.04(IV.)(A.).
Additionally, with respect to overcoming a finding of routine optimization, the applicant has not clearly demonstrated that the claimed dimension/size ranges are critical, that Bommarito teaches away from the claimed ranges, the claimed parameter was not recognized as result effective, or that the claimed variable is disclosed in a very broad range in the prior art; see MPEP 2144.04(III.)(A-D). Instead, the examiner finds that the device of Bommarito is generally indicated to include components on the scale of mm (e.g., see [0023]: microfluidic channel 1mm in diameter, with a length of 3.2 mm), and Bommarito discusses how the channel dimensions influence resistance to flow ([0021]-[0023]). Thus, although the cited sub flow channels of Bommarito are designed to deliver growth media as opposed to presenting a challenge to sterilant flow, the general size/scale of the device of Bommarito and a desire to reduce resistance to flow of the growth media through the sub flow channel of Bommarito would reasonably be expected to guide a person of ordinary skill in the art toward an embodiment of the device of Bommarito wherein the sub flow channel has at least one of a length between 2mm and 200 mm, a maximum width between 0.125 mm and 20mm, and a height between 0.05 mm and 25 mm.
Also, it is evident that the size of the indictor compartment should be sufficient to accommodate the biological indicator, allow the flow of sterilant thereto, include space to receive growth media, and be at least large enough to facilitate the detection of microorganism growth therein. With the scale of device components of Bommarito generally being on the scale of mm to cm (see [0023] as indicated above), it would be obvious to a person having ordinary skill in the art to arrive at a compartment volume between 0.25 cm3 and 10 cm3 for the benefit of providing sufficient space to accommodate a biological indicator, to receive sterilant, to receive growth media, and to allow observation of microbial growth within the compartment, while maintaining a compact device. Thus, the rejections of claims 17 and 19 are maintained.
The modified grounds of rejection are set forth below.
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 8, 10, 13-14, 17, 22, 24, and 34 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.
As amended, claims 8, 10, 13-14, 17, 19-20, and 24 have been adjusted to depend from claim 2. Claim 2 is directed toward a device which includes a plurality of challenge networks, each challenge network including at least a flow channel with an entry port, and each challenge network further including more than one indicator compartment comprising a biological indicator.
Claims 8, 10, and 13-14 refer to “the flow channel”. This language in the dependent claims is ambiguous because the base device which the dependent claims modify includes a plurality of flow channels, such that it is not clear which flow channel(s) is/are being referred to. That is, it is not clear if the limitations the dependent claims 8, 10, and 13-14 should be interpreted as applying to each flow channel of the device, or if the limitations should instead be read as applying to at least one flow channel of the device. The claims should be adjusted to clarify which flow channel(s) are being referred to, such as by adjusting “the flow channel” to read “at least one flow channel of the device”, or “each flow channel of the device”. Other clarifying adjustments are appropriate.
Claim 17 is rejected at least by virtue of dependency on claim 14.
Claim 22 refers to “the biological indicator”. Since the base device (claim 2) which claim 22 depends from includes multiple biological indicators, it is ambiguous which biological indicators the limitation of claim 22 applies to. That is, it is not clear if the limitation of claim 22 requires that each and every biological indicator of the device includes at least one of the recited microorganisms, or if the limitation only applies to at least one of the biological indicators of the device. The claim should be adjusted as similarly suggested with respect to claims 8, 10, and 13-14; i.e., replace “the biological indicator” with “each biological indicator of the device” or “at least one biological indictor of the device”.
Claims 24 refers to “the more than one indicator compartment“. This language in the dependent claims is ambiguous because the base device (claim 2) which the claim 24 modifies includes multiple sets of “more than one indicator compartment”, each set associated with a distinct challenge network. Thus, it is not clear which set of “more than one indicator compartment” is being referred to, and if the limitations of claim 24 should be interpreted as applying to each set of “more than one indicator compartment”, or if the limitations should be read as applying to at least one set of the “more than one indicator compartment”. It is suggested claim 24 be adjusted to recite “each of the more than one indicator compartment” (as in claim 19 and 20) or “at least one of the more than one indicator compartment” (or a variation thereof) instead of “the more than one indicator compartment”.
For purposes of examination, when it is not clear whether a limitation applies to all of a certain type of feature in the device (i.e., all flow channels, all biological indicators, or all sets of indicator compartments), the broadest reasonable interpretation of the claim is interpreted as referring to an embodiment wherein at least one of the recited type of feature (i.e., at least one flow channel, at least one biological indictor, or at least one set of indicator compartments) meets the recited limitation.
Claim 34 as amended recites “contacting the more than one indicator compartment with the at least one medium compartment”. It would appear that the “at least one medium compartment” should read “the nutrient medium”, as it is not immediately clear from the instant disclosure how the two compartments can be meaningfully made to contact within the context of the invention. The claim should be adjusted accordingly (e.g., by replacing “the at least one medium compartment” with “the nutrient medium), or it should be clarified on the record how the instant disclosure supports a step of “contacting” the two compartments.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bommarito (US 2018/0071418 A1).
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 indicators are disposed along length of channel—Fig. 2, [0017]—which clearly implies fluid communication of each indicator compartment with the flow channel 56; in a related embodiment, Bommarito indicates 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).
Claim 1 as amended further states that the sterilization monitoring device is configured to indicate a degree of sterilization for a given sterilization protocol based upon a number of the plurality of indicator compartments within the challenge network having indicators influenced by the sterilant at or above a sterilization threshold value.
Although Bommarito does not particularly discuss such use of the device, it is evident that the device of Bommarito is reasonably configured for such use. Particularly, Bommarito indicates that each biological indicator is analyzed and a parameter thereof is compared to a threshold value to determine if a sterilization procedure passed or failed at the location of the indicator (That difference in the spore population pre and post disinfection could then be compared to an expected difference for an effective cycle, and within a certain tolerance window, a determination could be made on whether the disinfection cycle was effective or not (pass or fail)… [alternatively] the pass/fail determination may then be based on how quickly the fluorescent intensity reached a given level—[0025]). Also, Bommarito teaches the device comprising multiple biological indicators (biological indicators 58, 60, 62—Fig. 2, [0017]) which can represent different challenges (the device could have multiple biological and chemical indicators disposed within the channel path to indicate multiple challenges simultaneously—[0027]; the device could be designed so that the microfluidic channel also included dead volumes either above or below the plane of flow as well as within that plane, to simulate valves and other dead flow ends common to the design of many flexible endoscopes. Indicators could be disposed at these locations to verify that an appropriate cycle was completed—[0028]). Accordingly, it is evident that when all of the biological indicators indicate a pass, all sterilization challenges are passed and a higher degree of sterilization has been achieved. Conversely, when fewer biological indicators indicate a pass, not all sterilization challenges have been passed and a lower degree of sterilization was achieved. Therefore, the device of Bommarito is reasonably configured to indicate a degree of sterilization for a given sterilization protocol based upon a number of the plurality of indicator compartments within the challenge network having indicators influenced by the sterilant at or above a sterilization threshold (more indicators achieving a threshold “pass” value in Bommarito fairly corresponds to a greater degree of sterilization).
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahimou et al. (US 2015/0337354 A1).
Regarding claim 1, Ahimou teaches a sterilization monitoring device (biological sterilization indicator device 500 for determining the effectiveness of a sterilization process—see [0113]) comprising:
a challenge network comprising: a flow channel (20) comprising an entry port (18) for receiving a sterilant (primary passageway 20 in fluid communication with an opening 18—[0113]; opening 18 provides communication between passageway 20 and ambience, and device 500 is exposed to sterilant in sterilization process—see [0113]-[0014]), and a plurality of indicator compartments (24), more than one indicator compartment comprising a biological indicator (test microorganism), and each indicator compartment being in fluid communication with the flow channel (microchambers 24 connected to primary passageway 20 and include a test microorganism –see [0013]-[0114]); and
a shell (body 10) encasing the challenge network such that access to the plurality of indicator compartments is only through the flow channel (body 10 of device 500—[0113]; body 10 comprises plurality of layers 12, 14, 16—[0050]—with passageway 20 and microchamber 24 disposed therebetween—[0052]; when opening 18 is blocked, test microorganisms are not in communication with ambience—[0114]; thus clear opening 18 is the only inlet to passageway 20 and path to chambers 24—see Fig. 14a).
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Ahimou further indicates sterilization monitoring device is configured to indicate a degree of sterilization for a given sterilization protocol based upon a number of the plurality of indicator compartments within the challenge network having indicators influenced by the sterilant at or above a sterilization threshold value ([0056]: In some embodiments, a biological sterilization indicator device of the present disclosure may comprise a plurality of microchambers, wherein the device comprises a first microchamber and a second microchamber. The first microchamber has disposed therein a first plurality of test microorganisms consisting of at least about 10 times as many spores as a number of test microorganisms disposed in the second microchamber. Similarly, the device may further comprise a third microchamber having disposed therein about 10 times fewer test microorganisms than the second microchamber. Advantageously, the said device may be used to quantitatively assess the effectiveness of a sterilization process. That is, an effective sterilization process may kill all of the test microorganisms in the first through third microchambers. In contrast, a less effective sterilization process may only kill the test microorganisms in the third microchamber and an even less effective sterilization process may only kill the test microorganisms in the second and third microchambers).
Regarding claim 2, Ahimou teaches the sterilization monitoring device discussed with respect to claim 1 above (see Fig. 14a). Ahimou teaches the casing (body 10) including two distinct challenge networks, each with a distinct flow channel (20, 20’), a fluid inlet (18, 18’) which can receive a sterilant from an ambient environment (18, 18’) and which fluid inlet is the only fluid access point to the corresponding flow channel, a plurality of indicator compartments (microchambers 24) including a biological indicator (test microorganisms) connected to the flow channel(s), and a compartment (60, 60’) for containing a growth medium liquid (64, 64’) in a frangible container (62, 62’) (see Fig. 14A, [0013]-[0014], and portions cited with respect to claim 1 above). Thus, Ahimou teaches a sterilization monitoring device (500) comprising:
a plurality of challenge networks, each challenge network comprising: a flow channel (20, 20’) comprising an entry port (18, 18’) for receiving a sterilant, and more than one indicator compartment (24) comprising a biological indicator (test microorganism) ,
at least one medium compartment (60, 60’) comprising a nutrient medium (64, 64’),wherein the at least one medium compartment is in fluid communication with the more than one indicator compartment (test microorganisms in microchambers 24 and 24’ are contacted with nutrient member 64 [by breaking frangible container 62, 62’]—[0113]); and
a shell (body 10) encasing the plurality of challenge networks such that access to the one or more than one indicator compartment is only through the flow channel[[s]] (see [0050], [0052], [0013]-[0014], and Fig. 14a, as discussed with respect to claim 1 above).
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, 8, 10, 14, 17, 19, 24-25, 28, 33-34, 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 2, 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 a single device to mimic the challenge posed by different types of endoscopes (see Bommarito at [0026]-[0028]).
Regarding claim 8, Bommarito discloses the sterilization indicator device of claim 2. 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 teaches 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).
Additionally, it is emphasized that Bommarito teaches that the channel[s] (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 teaches the limitations of 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 from 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 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]). Additionally, it is noted that changes in size and proportion are prima facie obvious absent persuasive evidence of significance; see MPEP 2144.04(IV.)(A.).
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 the indicator with a sterilant and subsequent contact with a growth media. 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 and growth media to flow into and/or around the indicator.
Regarding claim 24, Bommarito teaches the sterilization monitoring device of claim 2. 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 2. 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 2 (device 50—see rejection of claim 2 above regarding the obviousness of modifying the device of Bommarito to arrive at an embodiment of the device 50 consistent with the limitations of claim 2; 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 been 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 (growth media) from the at least one medium compartment 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]).
Regarding claim 41, the claim is directed to a kit which combines essentially combines the device of instant claim 2 with instructions for performing the method of claim 33. Accordingly, see the rejection of claim 2 above regarding how Bommarito renders obvious the sterilization monitoring device of claim 2, 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 2. 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 layers (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 the conditions of a sterilization procedure and for 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 2. 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 2. 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 each of the indicator compartments further includes 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 to the indicator compartment during a sterilization process (see Cregger at [0052], [0056]).
Regarding claim 22, Bommarito teaches the sterilization monitoring device claim 2. Bommarito teaches that biological indicator can operate in a manner consistent with conventional biological indicators, 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 indicators 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 2. 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gibbons (US 2021/0213150 A1, filed 22 December, 2020, with earliest priority date 09 January, 2020) teaches a cassette for use in a decontamination system which includes at least one process challenge device such as a biological and/or chemical indicator (abstract), wherein an embodiment of the cassette (Fig. 4) includes a plurality of inlet ports (408) leading into a respective plurality of tortuous channels (410) which each lead into a distinct compartment (404) for holding the process challenge device ([0043]). Gibbons essentially indicates that the arrangement of multiple process challenge networks (each comprising an inlet 408, channel 404, and indicator compartment 404) allows for the cassette to be used for multiple decontamination cycles (by selecting which inlet port is used each cycle—see [0043]).
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.
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/BRADY C PILSBURY/Examiner, Art Unit 1799
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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