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 group I, claims 1-19 in the reply filed on 1/13/26 is acknowledged.
Claims 20-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/13/26.
Applicant's election with traverse of the species of steam sterilization in the reply filed on 1/13/26 is acknowledged. The traversal is on the ground(s) that there is no serious search burden This is not found persuasive because of the reasons set forth in the restriction requirement mailed on 11/13/25, p5.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/13/26.
Priority
Application claims priority to 63/411,990 provisional application with an effective filing date of 9/30/22. Claims of the instant application are supported by the provisional application and thus have a priority date of 9/30/22.
Information Disclosure Statement
The IDS filed on 10/11/23, 1/22/24, and 2/8/24 have been fully considered except where references have been lined through.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "the air sample" in reference to claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
(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 1-6, 9, 13 and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Franciskovich (US20190017092A1).
Regarding claims 1 and 3, Franciskovich teaches a process (method) for determining the viability of a biological indicator (abstract). Franciskovich teaches that a sterilization detection device includes a container configured to contain the biological indicator, a viability detection medium, and the sensing device (self-contained) (abstract). Franciskovich teaches that the biological indicator comprises spores (claim 15). Franciskovich teaches that the biological indicator is exposed to a sterilization media (sterilization process) (claims 24-26). Franciskovich teaches that the medium can comprise a media with nutrients (growth media) (claims 6 and 7). Franciskovich teaches the biological indicator can be incubated ([0045]). Franciskovich teaches that exposing the biological indicator to a viability detection medium results in a gaseous reaction product if the test microorganisms are viable (claim 1). Franciskovich teaches that gaseous reaction product comprises a volatile organic compound (claim 19). Franciskovich teaches that the gaseous reaction product is produced upon germination of the viable test microorganism ([0041]). Franciskovich teaches that if viable microorganisms are detected the sterilization cycle was successful ([0068]). Franciskovich teaches that the space within the biological indicator can be detected (sampled) (fig 1 and [0046]).
Regarding claim 2, Franciskovich teaches that the detector is a gas detector (air sample). Franciskovich teaches that gaseous reaction product comprises a volatile organic compound (claim 19).
Regarding claim 4, Franciskovich teaches the sensing (sampling) device can be external to the contained biological indicator (fig 2a, [0054]).
Regarding claim 5, Franciskovich teaches that the determination of if the microorganism is determined to be alive can be immediate (sample collected and analyzed in less than about 60 mins) ([0011]).
Regarding claim 6, Franciskovich teaches steam can be the sterilizing media (claim 25).
Regarding claim 9, Franciskovich teaches that Geobacillus stearothermophilus and/or Bacillus atrophaeus can be used (claim 18).
Regarding claim 13, Franciskovich teaches that methane (alkane) can be detected (table 1).
Regarding claim 15, Franciskovich teaches that the population and make-up of the spores used can change depending on the type of sterilization used ([0050-0051]).
Regarding claims 16-17, Franciskovich teaches the change in the capacitance/current/oscillation frequency of the sensing device can be used to determine the gaseous reaction product (no enzymes or fluorescence) ([0120]).
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.
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Franciskovich (US20190017092A1) as applied to claims 1-6, 9, 13, and 15-17 above, and further in view of Hageage (EP0433053A1)
Regarding claim 10, Franciskovich does not explicitly teach the use of tryptic soy broth.
Hageage teaches rapid sterilization efficiency testing (abstract). Hageage teaches it comprises allowing spores to contact a growth media to support germination (abstract). Hageage teaches tryptic soy broth can be used (column 6 lines 8-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the germination media of Franciskovich with the TSB of Hageage. One of ordinary skill in the art would be motivated to do so because these media have been successfully used to grow spores after sterilization and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. There would be a reasonable expectation of success as both Franciskovich and Hageage are in the same field of endeavor of sterilization indicators using spores.
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable Franciskovich (US20190017092A1) as applied to claims 1-6, 9, and 13, 15-17 above, and further in view of Kluger, Bernhard, et al. )"Detection and identification of fungal microbial volatile organic compounds by HS-SPME-GC–MS." Laboratory protocols in fungal biology: current methods in fungal biology. New York, NY: Springer New York, 2012. 455-465)
Regarding claim 11, Franciskovich does not explicitly teach detection of a polar VOC.
Kluger teaches microbial detection of VOC via HS-SPME-GC–MS (abstract). Kluger teaches the method is applicable to many fungal species (abstract). Kluger teaches their procedure is highly flexible (introduction). Kluger teaches spores can be used (Cultivation of Fungi Using Spores). Kluger teaches polar compounds can be detected (notes 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a HS-SPME-GS-MS detection step in the method of Franciskovich (e.g., as a supplement to the detection method of Franciskovich, in order to further resolve and analyze VOCs), as taught by Kluger. One of ordinary skill in the art would be motivated to do so because Kluger teaches their method is highly flexible and can be used with spores. Further, one of ordinary skill in the art would be motivated to do so because these methods have been successfully used to detect VOCs from spores and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. There would be a reasonable expectation of success as both Franciskovich and Kluger are in the same field of endeavor of detecting VOCs from spores.
Regarding claim 14, Kluger teaches that compounds such as mono- and sesquiterpenes, alcohols, ketones, lactones and the so-called C 8 -compounds are commonly detected via GS-MS (introduction). Therefore, one of ordinary skill in the arts understands that the method of Franciskovich and Kluger would be able to detect the claimed compounds that are inherently produced by the germination of the spores, and it would have been obvious to analyze any compounds indicative of germination.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Franciskovich (US20190017092A1) as applied to claims 1-6, 9, and 13, 15-17 above, and further in view of Cheung (Metabolic profiling of volatile organic compounds and enhanced vibrational spectroscopy. The University of Manchester (United Kingdom), 2011.
Regarding claim 12, Franciskovich does not explicitly teach a background correction step.
Cheung profiles VOCs (title, abstract). Cheung teaches that VOCs can be used to rapidly identify biological samples including bacteria (abstract). Chung teaches that a baseline correction is needed to adjust the background intensity (growth media VOCs) of all samples to ensure that the data seen is accurate to the biological differences (section 1.4.3 Baseline correction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a baseline/background correction factor in the method of Franciskovich as taught by Chung. One of ordinary skill in the art would be motivated to do so because Cheung teaches that it is needed to ensure accurate data. Further, one of ordinary skill in the art would be motivated to do so because these baseline/background corrections have been successfully used in the measurement of VOCs and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. There would be a reasonable expectation of success as both Cheung and Franciskovich are in the same field of endeavor of bacterial VOCs.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable Franciskovich (US20190017092A1) as applied to claims 1-6, 9, and 13 15-17 above, and further in view of Senecal, Andre G., et al. ("Rapid detection of pathogenic bacteria by volatile organic compound (VOC) analysis." Chemical and Biological Early Warning Monitoring for Water, Food, and Ground. Vol. 4575. SPIE, 2002)
Regarding claim 18, Franciskovich does not explicitly teach using a control as a comparison for the germination.
Senecal teaches rapid detection of bacteria via VOC (title, abstract). Senecal teaches that media blanks can be analyzed (abstract). Senecal teaches that levels of peaks between the control and the bacteria incubated VOC can be different (figs 1 and 2, peak 11.28). Senecal teaches that this method can be used in highly sensitive sensors and rapid detection (conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a control analysis as taught by Senecal in the method of Franciskovich. One of ordinary skill in the arts would be motivated to do so because Senecal teaches the method is applicable to rapid detection and highly sensitive sensors. Further, one of ordinary skill in the art would be motivated to do so because controls are commonly used in the biological arts. There would be a reasonable expectation of success as both Senecal and Francikovich are in the same field of endeavor of bacterial VOCs.
Regarding claim 19, Senecal teaches that bacterially produced VOCs can be higher than the control peaks (figs 1 and 2, peak 20.63).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657