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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 Sept. 2025 has been entered.
Claims 17-36 are currently pending and are considered here.
Any rejection/objection not reiterated here has been withdrawn.
Response to Arguments
Applicant’s arguments in the Response of 30 Sept. 2025 have been considered but are moot in view of the new grounds of rejection below.
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.
Claims 17-19, 21-28 and 30-36 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Gabbert et al., Journal of Applied Microbiology 129.5 (2020): 1092-1101 (previously cited) in view of Meyer et al., Journal of applied microbiology 116.3 (2014): 533-541 (previously cited) and Szostek, Adrianna. Diss. University of Delaware, 2019.
Regarding claims 17 and 26, Gabbert teaches a concrete test coupon useful for disinfectant testing, wherein the coupon is made by a method comprising separating a coarse aggregate from a concrete mix and combining the obtained fine cementitious material with water to form a wet concrete slurry; drying the slurry to form a concrete piece; carbonating the dried concrete; and sterilizing the carbonated, dried concrete to form a sterilized, carbonated, dried concrete piece (p. 1094, under Concrete coupon production; and Concrete carbonation). The coupons were inoculated with infectious agents, exposed to a disinfection process and then assayed for the infectious agents to evaluate the effectiveness of the disinfection (p. 1095-1096, under Viral recovery and disinfection experiments).
Regarding claims 21, 22 and 33, Gabbert teaches the concrete piece is in the form of a 1 cm3 cube (p. 1094, under Concrete coupon production).
Regarding claims 23 and 34, Gabbert teaches that the drying step comprises drying at room temperature for at least 3 days (p. 1094, under Concrete coupon production). The range of at least 3 days taught by Gabbert encompasses the claimed value of 5 days, and it would have been obvious in view of Gabbert that the drying time could be for any period within such range sufficient to dry the particular concrete mixture being used. Gabbert teaches the same process for making the same concrete test coupon for the same purpose as in the instant claims, and there is no indication of criticality or unexpected benefit from the particular drying period in claims 23 and 34.
Regarding claims 24 and 35, Gabbert teaches that the carbonation step comprises incubating in a 5% CO2 atmosphere at 37 °C and 88% humidity for 7 days (p. 1094, under Concrete carbonation).
Regarding claims 25 and 36, Gabbert teaches that the dried and carbonated concrete piece is washed/rinsed in deionized water and sterilized by autoclaving at 121 °C for 15 minutes (p. 1094, under Concrete coupon production; and Concrete carbonation). While Gabbert does not teach washing three times, it would have been obvious in view of Gabbert that the washing step could encompass as many rinsings as needed, e.g. to remove any loose materials and/or contaminants. Moreover, the repeated washing steps recited in claim 16 are considered a duplication of parts/steps which does not distinguish Gabbert in the absence of any unexpected result from the repetition (see MPEP 2144.04, VI. B.). To the extent Applicant might argue that Gabbert teaches the washing step occurs prior to the carbonation step (it is unclear from Gabbert at p. 1094, under Concrete coupon production and Concrete carbonation, whether the washing occurs before or after carbonation), changes in the order of steps are considered prima facie obvious in the absence of any unexpected results (see MPEP 2144.04, IV. C.). There is no evidence of any new or unexpected result from washing after vs. prior to carbonation.
Claims 17-19, 21-28 and 30-36 differ from Gabbert in that: the test coupons are part of a sample setup comprising a plurality of coupons attached to a plurality of surfaces of different orientations so as to hang the coupons in multiple orientations in a room, including two or more, three or more and/or all of a ceiling ventilation orientation by being attached on a ceiling near a ventilation duct, a bottom orientation by being placed on a bottom of a water trough, an inverted orientation by being attached inverted under a table, an upside down orientation by being placed upside down on a floor, or a vertical orientation by being attached vertically to a wall (claims 17-20 and 26-32); the setup includes groups of coupons with each group being in a different orientation in a room, including a ceiling orientation by being attached on a ceiling of the room, a floor orientation by being placed on a floor of the room, and a wall orientation by being attached to wall surfaces of the room at different heights (claim 26); the test coupons are in an evenly dispersed grid format throughout the room (claim 27); 36 coupons are in an evenly dispersed grid format (claim 28); and the plurality of orientations for the groups of coupons of claim 26 further include at least one, two or all of a bottom orientation by being placed on a bottom of a water trough, an inverted orientation by being attached inverted under a table, or an upside down orientation by being placed upside down on the floor (claims 30-32).
Regarding claims 17-19, 26-28 and 30-32, Meyer teaches sample setup for sterility testing comprising a plurality of coupons arranged in series on a strip-like holder which is then mounted in various locations/orientations so as to allow for testing of fumigation/sterilization processes in an environment of interest (entire doc, including p. 536, under Coupon preparation and inoculation; Figs. 1 and 2). Each coupon holder holds a group of multiple coupons in series, including test coupons and a negative control coupon (p. 536, under Coupon preparation and inoculation; Fig. 2), and each holder is mounted in a different location/orientation within the testing environment (an HVAC ventilation system comprising a series of ducts) (p. 536, under Coupon preparation and inoculation; Figs. 2 and 3). The locations/orientations include mounting in a vertical orientation on a side of a wall-like surface (e.g., location A in Fig. 1), in a ceiling ventilation orientation on a ceiling on/near a ventilation duct and/or an inverted orientation under a flat ceiling surface (e.g., locations C and G in Fig. 1) and a bottom orientation on the bottom of an open chamber (e.g., locations B and F in Fig. 1).
Szostek teaches a method and sample setup for sterility testing that is substantially similar to that of Gabbert and Meyer, comprising a plurality of inoculated test coupons placed in a plurality of orientations within a testing environment (the undercarriage of a truck) in order to test the effectiveness of a spray disinfectant system at reaching various locations of a complex environment (under Ch. 2, including Table 1). The orientations included horizontal, vertical and complex (including inverted) orientations, with multiple coupons placed at multiple positions throughout the environment (p. 12-13, Table 1)
It would have been obvious to one of ordinary skill in the art at the time the invention was made to prepare concrete coupons for sterility testing as taught by Gabbert wherein the coupons are arranged in coupon holders that are attached in various orientations throughout a testing environment as taught by Meyer and Szostek because it would have been obvious to combine prior art elements according to known methods to yield predictable results. One of ordinary skill would have been motivated to arrange the coupons of Gabbert in coupon holders comprising multiple coupons in series as in Meyer in order to provide a convenient means for handling groups of related coupons intended to be exposed to a common testing environment, e.g. including multiple test coupons inoculated with different infectious agents and associated controls. One of ordinary skill would have been further motivated to mount multiple coupon holders in various orientations (including e.g. ceiling, bottom, inverted, upside down and/or vertical) throughout a testing environment as taught by Meyer and Szostek in order to test the effectiveness of a sterilization process at reaching various locations throughout a complex testing environment, e.g. including walls, floors, ceilings, nooks, etc. Arranging the coupons of Gabbert in coupon holders mounted in various locations as taught by Meyer would have led to predictable results with a reasonable expectation of success because the coupons of Gabbert are intended for the same type of sterility testing as taught in Gabbert and the 1 cm3 coupons of Meyer would be amenable to the same type of handling conditions as the similar-sized coupons of Meyer (cf. Meyer, p. 536, under Coupon preparation and inoculation).
Regarding the specific locations recited in the claims (on a ceiling near a ventilation duct, on a bottom of a water trough, under a table, on a floor, to a wall), Gabbert teaches that “[d]etermining effective chemical disinfection methods on surfaces commonly found in livestock and food-processing facilities is critically important to prevent and recover from outbreaks (p. 1098, 1st ¶), and that “[u]nsealed concrete is a porous material widely used in agricultural facilities, laboratories and food processing plants where environmental contamination with microorganisms may occur” (p. 1092, last ¶). The purpose of the testing methods/setups of Gabbert, Meyer and Szostek is to test the effectiveness of a sterilization process at reaching various locations throughout a complex testing environment, and the references teach placing numerous coupons at a variety of locations and in a variety of orientations/positions. Gabbert further teaches that the sample setup is particularly useful in environments such as agricultural facilities, laboratories and food processing plants where features such as ducts, water troughs, tables and the like would commonly be found. It would have thus been prima facie obvious for a sample setup to comprise coupons at any location within an agricultural facility, laboratory, food processing plant or other testing environment. As such, the various locations and orientations recited in the claims are not sufficient to patentably distinguish the claims from the cited references in the absence of new or unexpected results relating to a particular orientation/location.
Regarding claim 26, Meyer teaches use of a coupon holder comprising multiple test coupons and related controls that can be positioned together in a test environment. Likewise, Szostek teaches use of multiple coupons at each of various locations (Table 1). It would have thus been obvious for the sample setup of the cited combination to include groups of coupons at each locations/orientation (e.g., to test the effectiveness of the sterility process against a desired number of test microorganisms/viruses at each location and/or to provide backup testing, controls, etc.).
Regarding claims 27-28, wherein the coupons are in an evenly dispersed grid format and comprise 36 coupons, Meyer teaches use of a coupon holder comprising multiple evenly spaced test coupons and it would have been obvious to use multiple holders, each holding any desired number of coupons, as needed to provide a desired testing capacity (e.g., to test the effectiveness of the sterility process against a desired number of test microorganisms/viruses at each location and/or to provide backup testing, controls, etc.), including stacked holders that would result in a grid formation (see MPEP 2144.04, VI. B. - mere duplication of parts has no patentable significance unless a new and unexpected result is produced).
Claims 20 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Gabbert in view of Meyer and Szostek, as applied to claims 17-19, 21-28 and 30-36, further in view of Buhr et al., Frontiers in Bioengineering and Biotechnology 10 (2022): 875817 (previously cited).
Claims 20 and 29 differ from the combination of Gabbert in view of Meyer and Szostek, as applied to claims 17-19, 21-28 and 30-36, in that: each coupon is glued to a stainless steel magnetic disc (claims 20 and 29); the sample setup comprises magnetic strips positioned in multiple orientations to which the stainless steel magnet-attached coupons are bound/arranged along a longitudinal direction (claims 20 and 29).
The teachings of Gabbert, Meyer and Szostek are set forth above. Regarding claims 20 and 29, Meyer further teaches that each of the test coupons are attached to an adhesive-backed disk-shaped magnet which is used to magnetically attach the coupon to the holder (via a stub which inserts into the holder) (p. 536, under Coupon preparation and inoculation; Fig. 2(b) and 2(c)), and it would have been obvious that the coupons of the cited combination could be attached in the same fashion. One of ordinary skill would have been motivated to do so because the magnetic means allows for reversibly attaching the coupons and removing them for later handling, testing, etc.
Buhr teaches test coupons comprising a range of materials for disinfectant testing, wherein the coupons are arranged in a sample setup comprising a plurality of coupons attached/hung to surfaces of a substrate (a metal, i.e. magnetic, sheet) (p. 4, under Coupon materials and sterilization; p. 14, last ¶ to p. 15, 1st ¶; Fig. 7). Buhr further teaches that the test coupons were hung on the substrate by affixing magnets to the underside of each coupon and magnetically adhering the coupons to the metal sheet (p. 14, last ¶). The sample setup is subjected to a disinfection process, and the coupons are then removed from the setup and tested for the infectious agents to evaluate the effectiveness of the disinfection process (p. 4-6, under Coupon inoculation, extraction, and quantitation; p. 14, last ¶ to p. 15, 1st ¶).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make coupon holders as taught by Gabbert in view of Meyer and Szostek comprising a plurality of concrete coupons in series with the coupons attached to the holder via magnets, wherein the holder comprises a metal/magnetic strip to which the coupons/magnetic disks are attached because it would have been obvious to combine prior art elements according to known methods to yield predictable results. One of ordinary skill would have been motivated to attach the coupons with associated magnetic disks of Gabbert in view of Meyer and Szostek to a metal/magnetic strip substrate (as opposed to attaching the coupon-disks to hubs which are then inserted into slots of the holder, as in Meyer) because directly magnetically binding the coupons with associated magnetic disks to a magnetic strip would allow for a more simple and direct means for reversibly attaching the coupons to the holder with fewer component parts. Attaching the coupons with associated magnetic disks of Gabbert in view of Meyer and Szostek to a metal/magnetic substrate would have led to predictable results with a reasonable expectation of success because Buhr teaches attaching magnet-backed coupons directly to a metal/magnetic substrate, and Meyer further teaches magnetically attaching magnet-backed coupons to a holder indirectly via stubs as well as using magnetic strips in the holder to attach the holder to surfaces for sterility testing (see Meyer, Fig. 2(a) showing magnetic strips along the periphery of the holder). One of ordinary skill would have thus recognized that magnetic materials could be used to reversibly attach any components in the coupon/holder apparatus, including by incorporating metal/magnetic strips into the holder to which the magnet-backed coupons are attached.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J YAMASAKI whose telephone number is (571)270-5467. The examiner can normally be reached M-F 930-6 PST.
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, Melenie Gordon can be reached on 571-272-8037. 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.
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657