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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandrapati et al (US 20130224849).
Regarding claim 1, Chandrapati et al teach a biological sterilization indicator (Para. 0179 transparent to electromagnetic radiation including in Para. 0183 ultraviolet reads on "ultraviolet (UV) light test device"), comprising:
a population of viable microbial material (Para. 0189: spores 115 on a substrate); and
a container encapsulating the population of viable microbial material, the container formed of a material that is microbe impermeable, at least a portion of the container formed of a UV light transmissible material (Para. 046: housing 102 microorganism impermeable).
Chandrapati et al teach a dried spores (para. 00189: spores 115 dried down on a substrate), Chandrapati are silent to having a residual water content of the specific "less than five percent". In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a residual water content is a result effective variable that gives the well known and expected results of avoiding microbial activation prior to the analysis after sterilization. In the absence of a showing of unexpected results, the Office maintains the residual water content to less than 5% would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 2, Chandrapati et al teach the outer cap seals the biological sterilization indicator from fluid communication with the ambience (Para. 0027, "ambience" includes oxygen)
Regarding claims 3-4, Chandrapati et al teach biological sterilization indicators include viable quantity, or culture such that the amount are either killed by successful sterilization cycle or survives if the cycle is not adequate. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a population of viable microbial material is a result effective variable that gives the well known and expected results of providing the viable quantity to indicate a successful sterilization cycle. In the absence of a showing of unexpected results, the Office maintains the "a population of viable microbial material comprises between 3 to 9 logs of viable microbial material" and "the population of viable microbial material has a loss of viability of less than 0.5 logs over at least 30 days when stored at a temperature of 4 ºC" would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 5, Chandrapati et al teach the population of viable microbial material includes bacterial cells or fungal cells (Para. 0020: bacteria or fungi cell).
Regarding claim 6, Chandrapati et al teach a substrate bearing the population of viable microbial material disposed on the substrate (Para. 0189: spore carrier 135).
Regarding claim 7, Chandrapati et al teach spore strips in 6.4mmx6.4mm strips (Para. 0308: 41.2mm2 within "a flat surface with a surface area between 10 mm2 and 10,000 mm2").
Regarding claim 8-11, Chandrapati et al teach the population of viable microbial material comprises a stabilizing material; the stabilizing material comprises a sugar; the stabilizing material comprises an antioxidant (Para. 0111: glucose, it is noted that glucose is a known sugar and antioxidant); the stabilizing material comprises a growth nutrient (Para. 0111: nutrient medium)
Regarding claim 12, Chandrapati et al teach ultraviolet (UV) light test device (Para. 0179 transparent to electromagnetic radiation including in Para. 0183 ultraviolet reads on "ultraviolet (UV) light test device"), comprising:
a first compartment including a population of viable microbial material disposed on a substrate secured within the first compartment, the population of viable microbial material (Fig. 3; para. 0114: insert 130 to house the spores 115 on a spore carrier 135)
a UV light transmissible cover extending over the first compartment such that a UV light from a UV light source is able to contact the population of viable microbial material disposed on the substrate (Para. 0179 transparent to electromagnetic radiation including in Para. 0183 ultraviolet);
a second compartment sealed from the first compartment, the second compartment including a liquid growth media (Para. 3, para. 0110: container 120 having liquid 122 having nutrient medium);
a barrier separating the first compartment and the second compartment, the barrier adapted to be broken after the population of viable microbial material has been exposed to the UV light, the liquid growth media stored within the second compartment able to reach the population of population of viable microbial material once the barrier is broken (para. 0168, 0201: frangible container 120).
Chandrapati et al teach a dried spores (para. 00189: spores 115 dried down on a substrate), Chandrapati are silent to having a residual water content of the specific "less than five percent". In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a residual water content is a result effective variable that gives the well known and expected results of avoiding microbial activation prior to the analysis after sterilization. In the absence of a showing of unexpected results, the Office maintains the residual water content to less than 5% would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 13, Chandrapati et al teach the barrier comprises a frangible member (Para. 0201: frangible feature).
Regarding claim 14, Chandrapati et al teach comprising an indicator that provides an indication of whether there is residual viable microbial material after the population of viable microbial material has been exposed to the UV light and contacted with the liquid growth media (Para. 0019: indicators test if either successful if the spores are killed or unsuccessful if the not adequate).
Regarding claims 15-16, Chandrapati et al teach biological sterilization indicators include viable quantity, or culture such that the amount are either killed by successful sterilization cycle or survives if the cycle is not adequate. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a population of viable microbial material is a result effective variable that gives the well known and expected results of providing the viable quantity to indicate a successful sterilization cycle. In the absence of a showing of unexpected results, the Office maintains the "a population of viable microbial material comprises between 3 to 9 logs of viable microbial material" and "the population of viable microbial material has a loss of viability of less than 0.5 logs over at least 30 days when stored at a temperature of 4 ºC" would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 17, Chandrapati et al teach the population of viable microbial material includes bacterial cells or fungal cells (Para. 0020: bacteria or fungi cell).
Regarding claim 18, Chandrapati et al teach spore strips in 6.4mmx6.4mm strips (Para. 0308: 41.2mm2 within "a flat surface with a surface area between 10 mm2 and 10,000 mm2").
Regarding claim 19, Chandrapati et al teach a method of evaluating the efficacy of a sterilization process (Para. 0029: radiation includes "germicidal light"), comprising:
removing a germicidal light test device from a sealed container (Para. 0025: biological sterilization indicator is sealed from ambience),
exposing the germicidal light test device to a germicidal light for a duration of time and at a certain distance Para. 0027: exposing the biological sterilization indicator to the sterilization load, Para. 0029: radiation sterilization process),
performing an analysis to determine the effectiveness of the germicidal light (para. 0183: detection process).
Chandrapati et al are silent to securing the germicidal light test device in a fixed orientation and removing the germicidal light test device from the fixed orientation. It is desirable to provide the biological sterilization indicator in a fixed orientation to ensure the sterilization process is repeatable in the same orientation for future sterilizations with other devices. Therefore it would have been obvious to try securing the germicidal light test device in a fixed orientation and removing the germicidal light test device from the fixed orientation choosing from a finite number of identified, predictable solutions to provide the above advantage of reproducing the sterilization process that was evaluated by the indicator.
Regarding claim 20, Chandrapati et al teach the biological material is contained within the germicidal light test device and is not exposed to the environment. (Para. 0025, 0123: Biological sterilization indicator is sealed from ambience)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. 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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/Dennis White/Primary Examiner, Art Unit 1758
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