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 .
Election/Restrictions
Applicant’s election without traverse of claims 12-25 and the species of claim 16 in the reply filed on 5/29/2026 is acknowledged.
Claims 1-34 are pending.
Claims 1-11, 17-22, 26-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/29/2026.
Claims 12-16, 23-25 have been considered on the merits herein.
Claim Interpretation
Claim 12 is interpreted to require an additive that comprises 1) a carbon source unit or 2) a carbon source molecule containing a part that forms a volatile organic compound and 3) a volatile organic compound unit. Thus 1) or 2) together with 3).
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.
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) 12-16, 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2019014313 (IDS) to Centanni et al. in view of Ahimou et al. (US20210311002, IDS) and Rambach (US20090280524, IDS).
Regarding claim 12, WO2019014313 teaches a biological indicator having a container (p. 4, 1st full parag., lines 1-6), microorganisms/spores disposed on a carrier (p. 18, 2nd full parag., biological indicator section, p. 24, last parag.-p. 25, whole page), and an assay medium comprising a nutrient source, i.e. growth/nutrient medium (p. 10, 1st full parag., p. 12, 1st parag. and last parag., p. 21, 1st full parag.).
The microorganisms of the biological indicator metabolically respond (to sterilization) and produce a chemical (enzyme, for example) or a combination of chemical and a gaseous reaction product/volatile organic compound including methane (p. 3, lines 24-27, p. 5, 1st parag., p. 12, 1st parag., p. 21, 1st full parag., Table 1) when viable microorganisms are present after sterilization (p. 2, last parag.-p. 3, lines 1-6, p. 4, whole full 2nd parag., p. 21, 1st full parag.), if the microorganisms are not viable, the generation of a gaseous reaction product/VOC will not occur (p. 22, whole page).
Regarding claim 13, the indicator comprises spores of Geobacillus stearothermophilus or Bacillus atrophaeus (p. 3, lines 18-22, p. 5, 1st parag.).
Regarding claim 24, the indicator comprises the assay medium in a frangible ampoule and lid which is an ampoule crusher (p. 27, 2nd and 3rd parag., p. 28, last parag.).
Regarding claim 25, while the reference does not specifically teach the release of the enzyme alpha-glucosidase, they do teach that the enzyme produced by viable microorganisms being present in the nutrient/assay medium results in the production of a VOC. Further, it is known that the claimed microorganisms produce and have alpha-glucosidase activity.
The above reference differs from the claimed invention in that they do not teach an additive, wherein the additive comprises (1) a carbon source unit or (2) a carbon source molecule containing a part that forms a volatile organic compound when oxidized, and (3) a volatile organic compound unit, or the limitations of claims 14-16, and 23.
Regarding claim 12, Ahimou teach a self-contained biological indicator comprising a container, i.e. a housing (0010, 0011, 0054), spores disposed on a carrier/substrate (0061-0063, 0109), a growth medium (0091-0093, 0143) and an additive comprising a carbon source unit, i.e. enzymatic substrates, sugars and amino acids, for example, to detect enzymatic activity and effective sterilization of the spores within the indicator (0005-0006, 0037-0051, 0071, 0072, 0091, 0093).
Regarding claim 13, the indicator comprises spores of Geobacillus stearothermophilus (0063). The reference teaches that the microorganisms/spores are the source of the enzyme utilized to determine sterilization efficiency (0059) and the enzyme is α-glucosidase (0064, 0065, 0072). The enzyme acts on a substrate to convert the substrate to an enzyme-modified product which is detectable based upon chromogenic or fluorescent substrates or wherein substrates are converted by the enzyme which are further reacted with a compound to give a fluorescent or colored compound (0066-0068).
Regarding claim 14, the growth medium comprises tryptic soy broth or modified soybean casein digest broth (0093, 0142)
Regarding claims 15 and 16, the additive is 4-methylumbelliferyl alpha-D-glucopyranoside having the following structure, which includes an alpha-glucopyranoside carbon source unit, a glucose unit, and a functional alkyl (the hydroxymethyl group and the methyl group attached to the aromatic ring.
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Regarding claim 23, the additive, i.e. the enzyme substrate, is added in amounts of 1mM, as the reference teaches adding 10-3 (0102).
Regarding claim 24, the indicator comprises a growth medium ampoule and an ampoule crusher, i.e. a frangible container (0010, 0011, 0026, 0041, 0126).
While Ahimou teaches an additive which includes an alpha-glucopyranoside carbon source unit, a glucose unit, and a functional alkyl (the hydroxymethyl group and the methyl group attached to the aromatic ring), the additive does not contain a volatile organic compound unit.
Rambach US20090280524 teaches a chromogenic or fluorescent substrate for alpha-glucosidase (which may include 4-methylumbelliferyl, for example (0044) or other substrates (0041)) and an activator of a colored reaction including methyl-alpha-glucoside (0024, 0027, 0031, 0040-0044) for detection of microbes. Methyl-alpha-glucoside has the structure of claim 16 and the components of claim 15.
Thus, before the effective filing date of the claimed invention, self-contained biological indicators comprising a container, spores disposed on a carrier, a growth medium, and an additive comprising a carbon source unit, i.e. enzymatic substrates, to detect enzymatic activity and effective sterilization of the spores within the indicator was known and described by the art of record. The spores within the indicators are taught to be an enzyme source and Centanni teach that spores of the biological indicator metabolically respond (to sterilization) and produce a chemical (enzyme, for example) or a combination of chemical and a gaseous reaction product/volatile organic compound including methane if viable microorganisms are present after sterilization. Therefore, the spores within the indicator (having alpha-glucosidase activity) in a nutrient broth will naturally produce volatile organic compounds as the nutrient media claimed contain carbon sources and the spores naturally possess the enzymatic activity. Further, enzymatic substrates are routinely used in biological indicators to detect enzymatic activity and sterilization efficiency as seen in Ahimou and Rambach. Rambach teaches that the addition of methyl-alpha-glucoside, i.e. the additive according to claims 15 and 16, enhances the detection of the enzymatic reaction product. Ahimou also teaches adding compounds which react with enzyme cleavage products to provide a detectable enzymatic reaction product (0067, 0068). Thus, it would have been obvious to a phosita to add the claimed additive to a self-contained biological indicator as these additives not only would be cleaved by the naturally occurring alpha-glucosidase enzyme of the spores within the indicator to release a VOC, but these additives enhance the reaction product enabling enzymatic activity detection and the detection of the presence of viable spores (if present) within the nutrient medium after sterilization. Therefore, a phosita would have a reasonable expectation of successfully using the claimed additive in a biological indicator to generate an enzymatic reaction and wherein the release of the enzyme as a result of the spores being present results in a detectable volatile organic compound.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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