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 Objections
Claim 1 recites ‘4-MUG’. It is clear that the applicant is referring to a 4-methylumbelliferyl-β-D-galactopyronoside, however, the applicant should define the term ‘4-MUG’ in the claim as such.
Claims 1, 4, 5, 7, and 9 recite steps to a method with nomenclature that reads as ‘S100’, ‘S200’, ‘S300’ , S401 and so forth, which are also not in a consistent series as further recited in claims 5, 7, 9. The steps with regards to a method should be amended to recite , ‘Step 1’, ‘Step 2’, ‘Step 3’, etc.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4,6-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pasmore, M.E. et al., (US20100081165A1; published 2010-04-01).
Regarding Claims 1 and 2, Pasmore et al., teaches a method for determining the survival of spores ( Bacillus atrophaeus, Bacillus subtilis, Geobacillus stearothermophilus and Bacillus pumilus), (page 6, paragraph 0064), following a sterilization process. Methods include: performing sterilization treatment on spores, for a prepared spore suspension assessed for viability, in which sterilized media flows into a self-contained chamber containing an indicator with spores. The indicator is suitable to hold spores, a solid growth medium with 4-methylumbelliferyl-β-D-galactopyronoside (4-MUG) .Fluorescence is detected at an excitation wavelength of 365±20 nm, to measure viable spores. (;(pages 6-7, paragraph 0066-0067).
Regarding Claim 3, Pasmore et al., teaches methods for determining spore survival wherein the sterilization treatment is moist heat (steam/autoclaving) hydrogen peroxide, and ethylene oxide sterilization processes (page 5, paragraph 0057).
Regarding Claim 4, Pasmore et al., teaches methods for determining survival conditions of spores tested on glass fiber-based support, polymeric support, hydrophilic membrane, and “any suitable support materials” (page 6, paragraph 0065).
Regarding Claim 6-7, and 10 Pasmore et al., teaches methods for preferably preparing a growth media (tryptic soy agar; TSA) and determining survival conditions of spores, for testing sterilization applications by measuring 4-MUG or 4-MUD, at fluorescence excitation of 365±20 nm, using a quantitative fluorescent reader (pages 6-7, paragraphs 0066- 0067); preparation methods of media are further described (see page 8, paragraphs 0077-0078).
Regarding claim 8, Pasmore et al., teaches the ingredients and steps for preparing TSA (a 1-liter solution of agar, tryptic soy broth, and distilled water), and the addition of 0.2g of 4-MUG to a 1-liter solution. A containment device of the apparatus retains liquid media and is mounted to a compartment, the bottom of the compartment contains an indicator with a specified concentration of bacterial spores; after autoclaving (high temperature steam sterilization) the sterilized TSA with MUG flows into the chamber containing the indicator, and the media solidifies. The indicator (containing spores and solid TSA) is incubated in a fluorescence incubator reader to detect viable spores ; page 8, paragraphs 0077- 0078).
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.
Claim 5, is rejected under 35 U.S.C. 103 as being unpatentable over Pasmore et al., (US20100081165A1; published 2010-04-01) and in view of Powers, E.M. (Method for Obtaining Free Bacterial Spores of Bacillus subtilis var. niger.1968. Applied Microbiology.(16): pp180-181).
The teachings of Pasmore, et al., are previously disclosed.
Pasmore et al., does not disclose methods for obtaining the suspension of spores subjected to sterilization treatment.
However, Powers, E.M. teaches classical methods of harvesting spores and separating spores from a growth suspension (page 180, paragraphs 1-5).
The motivation to combine the teaching of Pasmore et al., with Powers, E.M. are simply to isolate viable spores from other debris/contaminants present in the media, and to detect the fluorescent by-product of 4-MUG metabolism by viable spore germination.
Therefore, it would have been obvious to one of ordinary skill in the art at the effective date of filing to combine the methods of Pasmore, et al., with Power, E.M. to isolate spores, post-sterilization, to assess viability. The methods taught by Powers, E.M. prescribe to classical and well-established isolation techniques generally practiced in the art, including standard, analog methods for sterilization testing. Accordingly, one would expect success with the combined methods of Pasmore, et al., and Power, E.M. in purifying spores, as described in the instant application which prescribes the same methods as the prior art.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Pasmore, M.E. et al., (US20100081165A1; published 2010-04-01) and in view of Hehenberger, R.K. (EP1200136B1; published 2008-05-07) and further in view of Woo, P.C.Y. et al., (Agar Block Smear Preparation: a Novel Method of Slide Preparation for Preservation of Native Fungal Structures for Microscopic Examination and Long-Term Storage. 2010. Journal of Clinical Microbiology. (48:9): pp 3053-3061).
The teachings of Pasmore, et al., are previously disclosed.
Pasmore, et al., does not teach arranging a pad on a periphery region of a solid medium and using a polydimethylsiloxane (PDMS) cover plate and observing the solid medium in an observing region.
However, Hehenberger et al., teaches the use of polysiloxanes (page 8, paragraph 0049) a family of silicone-based compounds that include polydimethylsiloxane, in which the sterilization indicator is coated with said compound. The sterilization indicator, is placed into a reader to measure fluorescence to detect viable spores post-sterilization (page 8, paragraph 0049; page 9, paragraph 0056). PDMS is well known to be an optically clear material and is subsequently a material with a usable interface in the detection of fluorescence.
Further, Woo et al., teaches a method for examining spore development and germination, using a slide-culture method. Wherein, an agar media with specified dimensions is incubated with a spore producing microorganism and examined for fluorescent output based on an incorporated fluorophore (page 3057, Fig.1; page 3058, paragraph 4).
The motivation to combine Pasmore et al., in view of Hehenberger, R.K. et al., and further in view of Woo et al., is simply to shift currently established methods and materials used with spore indicator testing to an analog method of microscopy-based analysis. The essential methods to assess sterilization remain the same as compared with the prior art taught by Pasmore et al., and Hehenberger et al., the same: growth medias and their preparation methods, organisms/spores, sterilization techniques, the fluorescent compound(s) used to indicate viable/germinating spores. A simple combination of these same methods provides a visual output for microscopic analysis, that is the same data produced from digital/spectral readings by Pasmore et. al., and Hehenberger et. al.
Therefore, it would have been obvious to one of ordinary skill in the art at the effective date of filing to modify the methods of Pasmore et al., with Hehenberger et al., and further in view of Woo et al. to transition existing methods of detecting spore viability from a digital output platform to an analog method. An analog method, such as fluorescent microscopy, using a PDMS cover plate placed over a sample cultured on a microscope slide, still requires the same test methods to validate sterilization efficacy as described by the prior art. Therefore, the methods and the outcome of the methods in the instant application would be the same as the prior art.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653