DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. The amendment filed 02 June 2026 has been received and considered for examination. Claims 1, 3-11, 14, and 16-21 are presently pending, with claims 16-21 withdrawn from consideration and claims 1, 3-11, and 14 being examined herein.
3. All rejections and objections from the previous Office action are withdrawn in view of Applicant’s amendment.
4. New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments, as detailed below.
Claim Objections
5. Claim 1 is objected to because of the following informalities: in lines 8-10, “comprising a select one or more of a temperature sensor, a pressure sensor, a concentration sensor, and a flowrate sensor positionable within the indicator module to provide respective temperature, pressure, concentration, and flowrate data of the one or more fluids” recites an intended purpose that could be construed to require all of the listed types of data in all instances of the claimed apparatus. Examiner recommends revising to e.g., --comprising a select one or more of a temperature sensor positionable within the indicator module to provide respective temperature data of the one or more fluids, a pressure sensor positionable within the indicator module to provide respective pressure data of the one or more fluids, a concentration sensor positionable within the indicator module to provide respective concentration data of the one or more fluids, and a flowrate sensor positionable within the indicator module to provide respective flowrate data of the one or more fluids--, to clarify that not all listed types of data are required in cases without all types of sensors present. Appropriate correction is required.
Claim Rejections - 35 USC § 103
6. 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.
7. Claims 1, 3, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al (US 20060218994 A1).
8. Regarding claim 1, Lin teaches an apparatus for reprocessing a device (apparatus 10 which contains a washing chamber 20 for washing medical devices and instruments, par 0150, FIG. 9) comprising:
(a) a basin configured to receive the device for reprocessing (FIG. 9, washing chamber 20 for washing medical devices and instruments, par 0150) wherein the basin is further configured to receive one or more fluids to aid in reprocessing (clean wash water to enter chamber 20, pars 0150-0152);
(b) one or more pumps configured to transfer the one or more fluids to and from the basin (Pump 60 pumps the washing or rinsing liquid from washing chamber 20…and to the washing chamber 20, par 0150, FIG. 9);
(c) one or more valves configured to direct the one or more fluids being transferred by the one or more pumps (FIG. 9, valves 41, 46, and 47; pars 0150 and 0152); and
(d) an indicator module fluidly connected with, but physically separate from, the basin (FIG. 9, conduit 55 with electrode probe 70, pars 0150-0152).
Lin teaches in the embodiment of FIG. 9 an electrode probe 70 positioned in the conduit 55 to monitor cleanliness wherein if the potential of the rinse liquid following the wash cycle is substantially equal to the time 0 potential reading, adequate cleaning has been achieved (par 0152). The electrode probe is described in greater detail as a soil detector that measures a voltage to resolve the dissolved inorganic soil concentration (pars 0061-0085), reading upon a concentration sensor positionable within the indicator module to provide respective concentration data of the one or more fluids. Lin does not teach in this embodiment the receipt of one or more indicators configured to signal when a predetermined level of decontamination is achieved.
In another embodiment, Lin teaches wherein the module is configured to receive one or more indicators (cleaning indicator, standard 138…used with the above mentioned cleaning apparatus, par 0177; to simulate the [device] needed to determine the cleaning efficiency, pars 0174-0176), wherein the one or more indicators are configured to signal when a predetermined level of decontamination has been achieved (cleaning efficiency can be determined visually or via an instrument, par 0184).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include within the FIG. 9 embodiment one or more soil indicator modules positioned in the conduit as taught by Lin in FIGS. 16A-B, pars 0174-0181, because doing so would predictably provide the same ability to reliably signal when a predetermined level of decontamination has been achieved in a simulation of the cleaning process within the basin, as Lin teaches in the operation of the FIG. 9 apparatus (pars 0150-0152).
The limitation wherein, for the one or more fluids within the indicator module, a select one or more of a first temperature, a first pressure, a first concentration, and a first flowrate are adjusted to substantially match, for the one or more fluids within the basin or within one or more channels of the device, a second temperature, a second pressure, a second concentration, and a second flowrate is recited as an intended use of the apparatus, which does not carry patentable weight per MPEP 2114(II) as the limitation does not structurally modify the apparatus. Examiner notes that Lin contemplates adjusting the cleaning efficiency of the standard relative to the items (par 0169), proposing controlling fluid communication via a valve or providing agitation to the enclosure (par 0169), either of which demonstrates that the apparatus of Lin is capable of carrying out the intended use of adjusting at least a first concentration within the indicator module to substantially match a second concentration within the basin.
9. Regarding claim 3, Lin teaches the apparatus of claim 1. The limitation wherein the one or more fluids received by the basin are transferred to the indicator module such that the basin and the indicator module contain the same fluid is recited as an intended use of the apparatus, which does not carry patentable weight. See MPEP 2114(II).
Examiner notes that the FIG. 9 device of Lin as modified above is capable of achieving wherein the one or more fluids received by the basin are transferred to the module such that the basin and the module contain the same fluid (pump 60 pumps the washing or rinsing liquid from washing chamber 20…into liquid conduit 55, par 0150).
10. Regarding claim 9, Lin teaches the apparatus of claim 1, wherein the one or more indicators comprise (embodiments of the apparatus of the invention illustrated in FIGS. 9-15d can employ one or more additional soil detectors, par 0174) a reference well (additional substrate to mimic real world conditions, par 0178, FIG. 16B) and a sample well (two substrates 140 and 142 held in parallel, pars 0177-0178, FIG. 16A), wherein the indicator module comprises “one or more detectors for detecting inorganic soil in combination with an ultraviolet-visible detector suitable for detecting protein and other organic species” (par 0174).
Although Lin does not specifically disclose the arrangement of a reference light source, a reference light detector, a sample light source, and a sample light source detector, Lin does teach wherein the use of a spectrophotometer is preferable to detect protein and other organic species (par 0174) on the soil indicator, which is embodied in FIGS. 16A-B as a reference substrate (FIG. 16B, 150) and a sample substrate (FIG. 16A, 140 and 142) that are preferably transparent (par 0179). When describing the spectrophotometer in another embodiment, a detector and light source are positioned with space between for the transparent analyte having a detectable color (par 0166), an analogous arrangement to the reference and/or test soil indicator. Lin further teaches that more than one detector may be advantageously used (par 0174). Thus, to determine the soil level by an instrument during the cleaning cycle (pars 0183-0184), a person having ordinary skill in the art would be motivated to arrange more than one detector and more than one light source such that the reference light detector detects light transmitted from the reference light source through the reference well and the sample light detector detects light transmitted from the sample light source through the sample well, as the source/detector are taught to operate in this manner individually with a transparent sample therebetween, and the embodiment of FIGS. 16A-B teaches the utility of having a dual soil detector setup with clean reference and soiled test samples.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the soil detectors of Lin such that a reference light detector detects light transmitted from a reference light source through the reference well and a sample light detector detects light transmitted from a sample light source through the sample well, because doing so would predictably, and with a reasonable expectation of success, provide a reliable UV-Vis spectrophotometry reading for the reference cleanliness target and the sample, enabling comparison of light transmission to achieve the desired cleanliness level in the cleaning process as taught by Lin.
11. Regarding claim 10, Lin teaches the apparatus of claim 9, wherein a successful decontamination state exists when the light transmission detected at the reference light detector and the sample light detector is substantially equal (if the soil detected in step (b) is substantially equal to the soil detected in step (a), the device is considered to be sufficiently cleaned, par 0147).
12. Regarding claim 11, Lin teaches the apparatus of claim 1, wherein the module comprises an indicator loading feature (holder 148 can be a clamp, clip, tape, screw, rubber band, snap-on cap, or any other holding method, par 0181) configured to position the one or more indicators within the module (to hold the substrates together, par 0181).
13. Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al (US 20060218994 A1) as applied to claim 1 above, and further in view of Ulhenhaut et al (US 20200116659 A1).
14. Regarding claim 4, Lin teaches the apparatus of claim 1, wherein the sterilization may be driven by heated air, heated liquid, or steam (pars 0011-0012). Lin does not teach a first temperature sensor located within the basin and configured to measure a first temperature of a select one of the one or more fluids within the basin.
Ulhenhaut teaches an analogous heat treatment device for sterilizing objects such as an endoscope (pars 0001-0002 and 0046-0051) wherein a temperature sensor 4 is arranged on the side of the Peltier element 3 that faces the process chamber 2, or, to be more precise, the cavity of the dummy endoscope 15 (par 0064, FIGS. 1 and 5). By facing the process chamber, the temperature sensor would be configured to measure a first temperature of a select one of the one or more fluids within the basin and advantageously ensure that the same sterilizing atmosphere has developed in the cavity of the endoscope as in the rest of the process chamber, as taught by Ulhenhaut (par 0048).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include within the basin of Lin a temperature sensor that faces the cavity of the device being sterilized as taught by Ulhenhaut, because doing so would predictably ensure that the device experiences sufficient sterilization temperatures in a similar manner to the dummy endoscope taught by Ulhenhaut.
15. Regarding claim 5, Lin as modified by Ulhenhaut teaches the apparatus of claim 4, comprising a material surrounding the first temperature sensor (Ulhenhaut FIG. 1, dummy endoscope 15 surrounds device 1 having temperature sensor 4) such that the first temperature measured by the first temperature sensor is representative of temperature within the internal region of the device (thermocouple 4 faces the cavity of the endoscope 15, par 0054).
The combination does not explicitly teach wherein the material is configured to provide insulating properties that resemble insulating properties the device provides to an internal region of the device. However, Ulhenhaut further teaches that the thermocouple is surrounded by a synthetic resin mass that serves as a thermal insulation for the device (par 0056), such that the thermocouple is insulated thermally from the basin and the temperature measured resembles the internal region of the device (par 0056).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further include surrounding the temperature sensor of modified Lin a material that has insulating properties as taught by Ulhenhaut, because doing so would predictably restrict heat transfer from the outside basin directly to the temperature sensor as taught by Ulhenhaut (par 0065), thus similarly resembling the insulating properties the device provides to an internal region of the device.
16. Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al (US 20060218994 A1) and Ulhenhaut et al (US 20200116659 A1) as applied to claim 4 above, and further in view of Yang (US 20180110892 A1).
17. Regarding claim 6, Lin as modified by Ulhenhaut teaches the apparatus of claim 4, wherein the sterilization may be driven by heated air, heated liquid, or steam (Lin pars 0011-0012). Although Ulhenhaut further teaches a Peltier element designed to actively heat and cool the temperature sensor (Abstract), the combination does not sufficiently teach a resistive heater configured to provide heat or cooling to the one or more fluids received by the indicator module.
Yang teaches an analogous heat treatment device for sterilizing objects such as an endoscope (pars 0019-0022) wherein temperature sensors are in operative communication with an inline heater to heat the liquid to optimum temperatures for cleaning and/or disinfection (par 0026). This liquid heating element is depicted as a resistive element and located within a circulation loop (FIG. 2) analogous to the conduit 55 of Lin.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include within the circulation module of Lin a resistive heating element as taught by Yang, because doing so would predictably provide the advantageous ability to heat the liquid to optimum temperatures for cleaning and/or disinfection for the fluids received by the module as taught by Yang.
18. Regarding claim 7, Lin as modified by Ulhenhaut and Yang teaches the apparatus of claim 6, wherein the temperature control feature is controlled based upon the first temperature measured by the first temperature sensor inline with the reprocessor heating loop (Yang par 0026). The combination does not teach that this first temperature sensor is located within the basin.
Ulhenhaut teaches an analogous heat treatment device for sterilizing objects such as an endoscope (pars 0001-0002 and 0046-0051) wherein a temperature sensor 4 is arranged on the side of the Peltier element 3 that faces the process chamber 2, or, to be more precise, the cavity of the dummy endoscope 15 (par 0064, FIGS. 1 and 5). By facing the process chamber, the temperature sensor would be configured to measure a first temperature of a select one of the one or more fluids within the basin and advantageously ensure that the same sterilizing atmosphere has developed in the cavity of the endoscope as in the rest of the process chamber, as taught by Ulhenhaut (par 0048).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to locate the first temperature sensor of modified Lin within the basin as taught by Ulhenhaut, as doing so would predictably enable control of the conditions for treating the endoscope via the temperature control feature.
19. Regarding claim 8, Lin as modified by Ulhenhaut and Yang teaches the apparatus of claim 6, wherein the sterilization may be driven by heated air, heated liquid, or steam (pars 0011-0012). Lin does not teach a second temperature probe located within the indicator module, wherein the first temperature and the second temperature are provided as inputs to a controller and define a temperature feedback loop, wherein the controller controls the temperature control feature based upon the temperature feedback loop.
Yang teaches an analogous heat treatment device for sterilizing objects such as an endoscope (pars 0019-0022) wherein temperature sensors are in operative communication with an inline heater to heat the liquid to optimum temperatures for cleaning and/or disinfection (par 0026). Another temperature sensor may be employed in the sensor chamber (par 0055). These two temperature sensors, including one within a circulation loop (FIG. 2) and another within a chamber (par 0055), provide input to a microcontroller which controls cleaning and/or disinfection cycles (par 0032), wherein the controller controls the temperature control feature based upon a temperature feedback loop (Based upon temperature and/or concentration values of disinfectant in the used disinfectant solution, controller 20 may be utilized to adjust…its temperature, par 0061).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include within the device of Lin a first and second temperature sensor to provide inputs to a controller as taught by Yang. Doing so would predictably improve temperature control, as the controller can control temperature based upon a feedback loop to e.g., provide an effective and minimally harmful exposure to the disinfectant as taught by Yang (par 0063).
20. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lin et al (US 20060218994 A1) as applied to claim 1 above, and further in view of Yang (US 20180110892 A1).
Regarding claim 14, Lin teaches the apparatus of claim 1, wherein one or more conditions within the indicator module are configured to substantially match respective conditions within the one or more internal channels of the device positioned within the basin (cleaning indicator to simulate the mated area…to mimic certain real world conditions, pars 0176-0178). Lin does not teach one or more flush lines, wherein the device comprises one or more internal channels, wherein the one or more flush lines are configured to connect with a respective one of the one or more internal channels of the device to direct the one or more fluids to the one or more internal channels of the device.
Yang teaches an analogous heat treatment device for sterilizing objects such as an endoscope (pars 0019-0022) wherein any internal channels of the endoscope are connected with flush lines such that liquid and air can be directed through the flush lines and any internal channels of the endoscope (par 0022). The system of Yang also includes one or more integral sensors to measure parameters relating to the reprocessing fluids that are positioned along the recirculation line (par 0052), analogous to the position of the module in Lin.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the recirculation line of Lin to include one or more flush lines configured to connect with internal channels of a device as taught by Yang. Doing so would predictably ensure the removal of waste material from the interior channels (Yang par 0042) and by virtue of fluidly connecting to circulate the fluid in the module, would predictably substantially match conditions within the one or more internal channels of the device positioned within the basin with the conditions in the module.
Response to Arguments
21. Applicant's arguments, see Remarks filed 02 June 2026 have been fully considered but they are not persuasive. Examiner clarifies that the proposed claim language agreed upon to overcome the rejection of record, see Interview Summary delivered 11 May 2026, did not include the limitation “a concentration sensor” in the listing of alternative sensors comprised by the indicator module. Lin teaches a concentration sensor configured to provide concentration data of the one or more fluids (e.g., electrode probe used as a soil detector in contact with liquid inside a liquid conduit to quantitate ions or electrolytes in solution, pars 0081-0085), meeting the added structural limitations of the claim. As detailed in the rejection of claim 1 above, a user can operate the device to meet the intended use of substantially matching the conditions between the module and the basin, with no further structural modification to the device required. Accordingly, claim 1 remains rejected as unpatentable under 35 U.S.C. 103 over Lin. Rejections of dependent claims 3-11 and 14 are updated herein to reflect the amendments to claim 1 and to claim dependencies.
Conclusion
22. 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.
23. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Talbert whose telephone number is (703)756-5538. The examiner can normally be reached Mon-Fri 8:00-5:00 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC TALBERT/Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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