DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive.
In response to Applicant’s argument that the prior art of Lippold et al. (US PG Pub 2002/0151084, “Lippold”) in view of Kippenhan et al. (US PG Pub 2003/0170901, “Kippenhan”) does not teach the newly amended limitation stating “a color value device configured to determine the discoloration of the polymeric indicator against a threshold color value used for determining the process condition of the oxidative treatment, wherein the process condition comprises at least one of an exposure time or an exposure concentration, or a combination thereof, to an oxidative chemical,” the Examiner respectfully disagrees. The prior art of Kippenhan et al. teaches that the color change of the indicator 70 is correlated to stored values to determine a sterilant exposure value, or concentration, see [0140]. The process condition in this case is the exposure concentration, or sterilant exposure value. The primary reference of Lippold also teaches that the color change may be quantified to provide an indication about the concentration of the oxidizing agent, see [0035] and [0050]. Therefore, the modification of the invention of Lippold to incorporate the color value device to monitor the process condition, or exposure concentration, would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application for the benefit of monitoring a color change with more precision than a human eye.
Further, the Applicant asserts that the prior art does not teach “a processor operatively coupled to memory, wherein the processor is in communication with the treatment apparatus to determine a degree of discoloration of the polymeric indicator used for determining, and to control, the process condition of the oxidative treatment based on the degree of discoloration, wherein the process condition comprises at least one of an exposure time or an exposure concentration, or a combination thereof, to an oxidative chemical,” and in response to this argument the Examiner respectfully disagrees. The prior art of Lippold teaches that the process condition comprises at least one of an exposure time or an exposure concentration, or a combination thereof, to an oxidative chemical (the concentration of sterilant is quantified by the color change, see [0050]), where the process control logic determines how much sterilant is used in the system to then induce a color change, see [0054]. Because the system is capable of monitoring how much sterilant enters the reaction chamber and inducing a color change in a sterilizing indicator, it meets the functional recitation of the processor being used to control, the process condition of the oxidative treatment based on the degree of discoloration, wherein the process condition comprises at least one of an exposure time or an exposure concentration, or a combination thereof, to an oxidative chemical.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 21, 23-26, 28, 30-39 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Lippold et al. (US PG Pub 2002/0151084, “Lippold”) in view of Kippenhan et al. (US PG Pub 2003/0170901, “Kippenhan”) and “Color - Britannica” as cited on the IDS.
Regarding claim 21, Lippold teaches a system for determining a degree of an oxidative treatment of an object (system for determining the presence of an oxidative agent, see Fig. 1 and [0030]), the system comprising:
a polymeric indicator (chemical indicator is made of polyurethane, or a polymer, see [0058]) configured for discoloration based on an oxidation of the polymer by a process condition of the oxidative treatment oxidizing the polymeric indicator (polymeric chemical indicator changes in color following exposure to the oxidizing agent over time, see Figs. 2 and 10, [0033], [0041], and [0058], hydrogen peroxide is a known oxidant of the amine group of polyurethane, see [0035] in the Instant Application; Regarding discoloration of the polymer based on an oxidation of an amine, methine, or methylene group of a polymer, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim);
a chamber configured to receive an object and the polymeric indicator (sterilization chamber 11 that contains an indicator and a medical instrument, see Fig. 1 and [0040]), the chamber configured to subject the object and the indicator to the oxidative treatment including the process condition (sterilization chamber subjects the indicator and medical instrument to oxidation, see [0040]). However, Lippold does not adequately teach or suggest that the system comprises a color value device configured to determine the discoloration of the indicator against a threshold color value used for determining the process condition of the oxidative treatment, wherein the process condition comprises at least one of an exposure time or an exposure concentration, or a combination thereof, to an oxidative chemical.
In the analogous art of systems for monitoring sterilization indicators, Kippenhan teaches a color value device (detector 83, see [0134] and [0201]) configured to determine the discoloration of the polymeric indicator against a threshold color value used for determining the process condition of the oxidative treatment (the detector is a spectrometer that measures color changes of indicator 70 against previous, or threshold, values by using a controller 81, see Figs. 18-20, [0133], and [0140]), wherein the process condition comprises at least one of an exposure time or an exposure concentration, or a combination thereof, to an oxidative chemical (the color change of the indicator 70 is correlated to stored values to determine a sterilant exposure value, or concentration, see [0140]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the device of Lippold comprising a color chart to determine color changes, to instead use the spectrometer to obtain color values as exemplified by Kippenhan for the benefit of electronically recording the results of sterilization for future reference by other users of the sterilization system (see [0148] in Kippenhan). Modifying the system of Lippold to include the spectrometer of Kippenhan would have had the reasonable expectation of successfully facilitating the determination of the color change of the indicator from one shade to another (see [0235] in Lippold), as is required by the instant application.
Regarding claim 23, modified Lippold teaches the system of claim 21, wherein the process condition is configured to oxidize the group (the oxidizing agent used is capable of oxidizing the polymer as hydrogen peroxide is a known oxidant, see [0035]. Regarding discoloration of the polymer based on an oxidation of an amine, methine, or methylene group of a polymer, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim);).
Hydrogen peroxide is a known oxidant to polymeric materials (see [0058] in Lippold), and therefore the structure of modified Lippold is capable of performing the process condition. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963).
Regarding claim 24, modified Lippold teaches the system of claim 21, but does not teach a processor operatively coupled to memory and in communication with the color value device to determine the discoloration of the polymeric indicator is greater than or equal to a threshold color value.
However, the analogous art of Kippenhan teaches a processor (processing means 81, see Fig. 19-20 and [0136]) operatively coupled to memory and in communication with the color value device (processing means 81 contains memory and is coupled to detector 83, see [0133]- [0136]) to determine the discoloration of the indicator is greater than or equal to a threshold color value (processor 81 is used to compare indicator 70 discoloration to threshold value, see [0136]).
It would have been obvious to a person possessing ordinary skill in the art before the effective date of the instant application to have modified the system of previously modified Lippold to include the processor of Kippenhan for the benefit of storing information regarding the reading for further analysis by a computer or user (see [0136] in Kippenhan). The modification of providing a processor to the color device of previously modified Lippold would have had the reasonable expectation of successfully facilitating of the analysis of spectral data following the exposure of the polymeric indicator to a sterilization treatment.
Regarding claim 25, modified Lippold teaches the system of claim 21, wherein the color value device comprises at least one of a spectrometer (the detector is a spectrometer that measures color changes of indicator 70, see Figs. 18-20, [0133], and [0140] in Kippenhan), a colorimeter, and a color chart (a Pantone color chart is used to compare and determine if a distinct color change has occurred, see [0066]- [0068] in Lippold).
Regarding claim 26, modified Lippold teaches the system of claim 21, herein the polymer comprises at least one of polyurethane and epoxy (chemical indicator is made of polyurethane, or a polymer, see [0058]).
Regarding claim 28, modified Lippold teaches the system of claim 21, wherein the object comprises a medical device (medical instrument, see [0040]).
Regarding claim 30, modified Lippold teaches the system of claim 21, wherein the oxidative chemical comprises hydrogen peroxide (hydrogen peroxide is the oxidative agent, see [0040]).
Regarding claim 31, modified Lippold teaches the system of claim 30, wherein the process condition comprises an exposure time of at least 5 minutes (items being sterilized are exposed to hydrogen peroxide for 10 minutes, which is longer than the instant requirement, see [0062]).
Regarding claim 32, modified Lippold teaches the system of claim 30, wherein the process condition comprises an exposure concentration of at least 2 mg/L (the hydrogen peroxide concentration is altered to ~6 mg/L to ensure a full reaction of the indicator, see [0066]).
Regarding claim 33, modified Lippold teaches the system of claim 21, wherein the discoloration comprises a change in an electromagnetic property of the polymeric indicator, the electromagnetic property comprising an absorption, a reflection, or any combination thereof, of an electromagnetic radiation by the polymeric indicator (the color change of the indicator is generated by an electromagnetic reaction involving hydrogen peroxide that then changes the color, or reflection, of the indicator, see [0030]- [0033] and [0041]).
Regarding claim 34, modified Lippold teaches the system of claim 33, wherein the electromagnetic radiation comprises a wavelength in a range of 400 nm to 700 nm (the color change is visible and therefore takes place at a wavelength of 400-700nm as that is the visible spectral range, see [0041] and Range of the visible spectrum from Brittanica.com).
Regarding claim 35, modified Lippold teaches the system of claim 34, wherein the electromagnetic radiation comprises a wavelength in a range of 550 nm to 600 nm (the color change is from red to tan/gold, which is in the visible range of 580-600nm as tan and gold are between orange and yellow, see [0041] and Range of the visible spectrum from Brittanica.com).
Regarding claim 36, modified Lippold teaches the system of claim 21, wherein the color value device comprises at least one of a spectrophotometer or a digital camera, or a combination thereof (the detector is a spectrometer, or spectrophotometer, that measures color changes of indicator 70, see Figs. 18-20, [0133], and [0140] in Kippenhan).
Regarding claim 37, modified Lippold teaches the system of claim 21, wherein the threshold color value is a CIELAB color space value and wherein the degree of discoloration comprises a change in b* value (the spectrometer is capable of capturing values of the color change, see [0235]- [0236] in Kippenhan, and is therefore able to capture a CIELAB color space value to capture a b* value)
Regarding claim 38, modified Lippold teaches the system of claim 23, wherein the process condition is configured to oxidize the group to form a quinone (the oxidizing agent used is capable of oxidizing the polyurethane, as hydrogen peroxide is a known oxidant, see [0035]).
Hydrogen peroxide is a known oxidant to polyurethane materials (see [0035] and [0058] in Lippold), and therefore the structure of modified Lippold is capable of performing the process condition of breaking down to form a quinone. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963).
Regarding claim 39, modified Lippold teaches the system of claim 38, wherein the quinone comprises a quinone-imide (the oxidizing agent used is capable of oxidizing the polyurethane, as hydrogen peroxide is a known oxidant, see [0035]).
Hydrogen peroxide is a known oxidant to polyurethane materials (see [0035] and [0058] in Lippold), and therefore the structure of modified Lippold is capable of performing the process condition of breaking down to form a quinone. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963).
Regarding claim 41, Lippold teaches the for performing an oxidative treatment on an object, the system comprising:
A polymeric indicator (chemical indicator is made of polyurethane, or a polymer, see [0058]) configured for discoloration based on an oxidation of the polymer by a process condition of the oxidative treatment oxidizing the polymer (polymeric chemical indicator changes in color following exposure to the oxidizing agent over time, see Figs. 2 and 10, [0033], [0041], and [0058]. Regarding discoloration of the polymer based on an oxidation of an amine, methine, or methylene group of a polymer, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim);
a treatment apparatus comprising:
a chamber configured to receive an object and the polymeric indicator (sterilization chamber 11 that contains an indicator and a medical instrument, see Fig. 1 and [0040]), the chamber configured to subject the object and the polymeric indicator to the oxidative treatment including the process condition (sterilization chamber subjects indicator and medical instrument to oxidation, see [0040]);
a dispenser configured to deliver an oxidizing agent of the oxidative treatment to the chamber (reactive agent dispenser 13 delivers hydrogen peroxide into chamber 11, see Fig. 1 and [0033]);
a pressure system configured to control a pressure of the chamber (vacuum pump 12 for releasing pressure within chamber 11, see Fig. 1 and [0033]); and
a generator configured to create plasma utilizing radio frequency energy, wherein the generator is in communication with the chamber (radio frequency generator 14 creates plasma for chamber 11, see Fig. 1 and [0033]);
and a processor operatively coupled to memory, wherein the processor is in communication with the treatment apparatus to determine the discoloration of the polymeric indicator and to control the process condition of the oxidative treatment based on the degree of discoloration (process control logic 16 is used to control sterilization based on if the indicator has changed color, see [0033]- [0035]), wherein the process condition comprises at least one of an exposure time or an exposure concentration, or a combination thereof, to an oxidative chemical (the concentration of sterilant is quantified by the color change, see [0050]).
The process control logic determines how much sterilant is used in the system to then induce a color change, see [0054]. Because the system is capable of monitoring how much sterilant enters the reaction chamber and inducing a color change in a sterilizing indicator, it meets the functional recitation of the processor being used to control, the process condition of the oxidative treatment based on the degree of discoloration, wherein the process condition comprises at least one of an exposure time or an exposure concentration, or a combination thereof, to an oxidative chemical.
However, Lippold does not adequately teach or suggest that the system comprises a color value device configured to determine the discoloration of the indicator against a threshold color value.
In the analogous art of systems for monitoring sterilization indicators, Kippenhan teaches a color value device (detector 83, see [0134] and [0201]) configured to determine the discoloration of the indicator against a threshold color value (the detector is a spectrometer that measures color changes of indicator 70 against previous, or threshold, values, see Figs. 18-20, [0133], and [0140]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the device of Lippold comprising a color chart to determine color changes, to instead use the spectrometer to obtain color values as exemplified by Kippenhan for the benefit of electronically recording the results of sterilization for future reference by other users of the sterilization system (see [0148] in Kippenhan). Modifying the system of Lippold to include the spectrometer of Kippenhan would have had the reasonable expectation of successfully facilitating the determination of the color change of the indicator from one shade to another (see [0235] in Lippold), as is required by the instant application.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758