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 .
Applicant's response filed 11/24/2025 has been fully considered. The following rejections
and/or objections are either reiterated or newly applied.
Status of Claims
Claims 1-20 canceled.
Claims 21-38 newly added.
Claims 21-38 pending and examined on the merits.
Priority
The instant application claims the benefit of priority to U.S. Provisional Application No. 63/119,849 filed December 1, 2020. Thus, the effective filing date of the claims is December 1, 2020.
The applicant is reminded that amendments to the claims and specification must comply with 35 U.S.C. § 120 and 37 C.F.R. § 1.121 to maintain priority to an earlier-filed application. Claim amendments may impact the effective filing date if new subject matter is introduced that lacks support in the originally filed disclosure. If an amendment adds limitations that were not adequately described in the parent application, the claim may no longer be entitled to the priority date of the earlier filing.
Information Disclosure Statement
The information disclosure statement (IDS) filed on November 21, 2024 has been entered and considered. A signed copy of the corresponding 1449 form has been included with this Office action.
Withdrawn Rejections
35 USC § 112(b)
The rejection of claims 1-20 under 35 U.S.C. 112(b) withdrawn in view of Applicant's cancelation of these claims in the claim amendments filed on 11/24/2025.
35 USC § 112(a)
The rejection of claims 1-20 under 35 U.S.C. 112(a) withdrawn in view of Applicant's cancelation of these claims in the claim amendments filed on 11/24/2025.
35 USC § 101
The rejection of claims 1-20 under 35 U.S.C. 101 withdrawn in view of Applicant's cancelation of these claims in the claim amendments filed on 11/24/2025.
35 USC § 103
The rejection of claims 1-20 under 35 U.S.C. 103 withdrawn in view of Applicant's cancelation of these claims in the claim amendments filed on 11/24/2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 32 and 37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claims 32 and 37: "compare any obtained VOC measurements from the one or more sensors to a threshold VOC value" provides a comparison (comparing measurements) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
These recitations are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or are mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Additionally, while claims 21 and 34 recite performing some aspects of the analysis on “a processing unit [] comprises a processor and non-transitory storage medium storing instructions”, there are no additional limitations that indicate that this requires anything other than carrying out the recited mental processes or mathematical concepts in a generic computer environment. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental processes” grouping of abstract ideas. As such, claims 32 and 37 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exceptions listed above are not integrated into a practical application because the claims do not recite an additional element or elements that reflects an improvement to technology. Specifically, the claims recite the following additional elements:
Claim 21: "a processing unit [] comprises a processor and non-transitory storage medium storing instructions" provides insignificant extra-solution activities (running instructions on generic computer components) that do not serve to integrate the judicial exceptions into a practical application.
Claims 21 and 34: "obtain one or more volatile organic compound (VOC) measurements" and "obtaining one or more VOC measurements of the interior volume of the body from the one or more sensors" provides insignificant extra-solution activities (obtaining and sensing environmental conditions are pre-solution activities involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
"display an indication with the one or more indicators when a VOC is measured by the one or more sensors" provides an insignificant extra-solution activity (displaying an indication is a post-solution activity involving data manipulation steps) that does not serve to integrate the judicial exceptions into a practical application.
Claim 34: "positioning a biological tissue in the interior volume of the body" provides an insignificant extra-solution activity (positioning biological tissue in a container is a pre-solution activity involving sample manipulation steps) that does not serve to integrate the judicial exceptions into a practical application.
The steps for obtaining and displaying data, and positioning a biological sample are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application because they are pre- and post-solution activities involving data gathering, data manipulation, and sample manipulation steps (see MPEP 2106.04(d)(2)). Furthermore, the limitations regarding implementing program instructions do not indicate that they require anything other than mere instructions to implement the abstract idea in a generic way or in a generic computing environment. As such, this limitation equates to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. Therefore, claims 32 and 37 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application, or equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
As discussed above, there are no additional elements to indicate that the claimed “processing unit [] compris[ing] a processor and non-transitory storage medium storing instructions” requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. Additionally, the limitations for obtaining and displaying data, and positioning a biological sample are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application.
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 32 and 37 are not patent eligible.
Response to Arguments under 35 USC § 101
Applicant’s arguments filed 11/24/2025 are fully considered but they are not persuasive.
Applicant asserts that the newly added claims 21-38 "include clear structural elements and explicit functions, and that as such any abstract ideas which may be recited [] are integrated into a practical application that reflects an improvement in technology surrounding how biological tissue is stored, transported and monitored prior to processing" (Remarks 11/24/2025 page 4). Examiner notes that while the independent claims do not recite abstract ideas, dependent claims 32 and 37 do, and are rejected under 35 USC 101 as outlined in the above relevant section.
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.
Claims 21, 23-24, 26, and 30-37 rejected under 35 U.S.C. 103 as being unpatentable over Christensen et al. (WO-2019040946).
Regarding claims 21 and 34, Christensen teaches a container comprising: a body having an interior compartment; a lid having an interior surface and a sensing unit affixed to the interior surface; wherein the lid is configured to be coupled to the body, thereby enclosing the sensing unit within the interior compartment of the body, and wherein the sensing unit is configured to obtain data about an environmental condition (Para.0015 "The container can have a lid. A first sensor of the one or more sensors can be attached to the lid" and Para.0029 "The temperature of the container can be transmitted to the server system, and can be used to generate alerts independent of or associated with the fill level of the container").
Christensen also teaches a processing unit contains instructions that, when executed, cause the processor to: process and store the data about the environmental condition, and determine a status based on the data; and wherein the indicator is configured to display an indication corresponding to the status (Para.0083 "A device API can be executed on the sensor. For example, the device API can be executed by a processor on a circuit board in the sensor, as described herein" and para.0080 "The routing app can record, track, display on the mobile device, and send vehicle location, orientation, and vehicle status data to the server system" and Figures 19-27 provide screenshots of various displays available containing status information, among other data).
Christensen also teaches a lid releasably coupled to the opening of the body (Para.0084 "The lid can be a cap that can be screwed onto and off of the body").
Christensen also teaches obtaining one or more VOC measurements of the interior of the volume of the body (para.0029 "The threshold level for the alert can be altered based on other sanitation issues (e.g., [] decomposition rate or smells or detected fumes or gasses").
Therefore, while Christensen does not suggest using trash cans for tissue sample monitoring, it does suggest monitoring degradation of the contained material and alerting based on detected gasses, which is reasonably pertinent to the problem Applicant is addressing with the disclosed invention (para.0029 "The threshold level for the alert can be altered based on other sanitation issues (e.g., [] decomposition rate or smells or detected fumes or gasses"). One skilled in the art would have a reasonable expectation of success because the method consists of a container housing one or more detectors and indicators, that can be minimally modified for the storage of biological tissues.
Regarding claims 23 and 24, Christensen teaches: the sensing unit comprises a device selected from the group consisting of an electrochemical sensor, a gas sensor, a metal oxide sensor, a gas chromatography apparatus, a mass spectrometry apparatus, a photo-ionization detector, and combinations thereof; and the environmental condition is selected from the group consisting of a temperature, a presence of volatile organic compounds (VOCs), a humidity level, an oxygen saturation level, a pH, and combinations thereof (Para.0029 "The temperature of the container can be transmitted to the server system, and can be used to generate alerts independent of or associated with the fill level of the container. []. The threshold level for the alert can be altered based on other sanitation issues (e.g., [] decomposition rate or smells or detected fumes or gasses - such as detected by humidity, gas, pH detectors, or combinations thereof, in the sensor)").
Regarding claim 26, Christensen teaches the processor-readable storage medium is selected from the group consisting of a secure digital (SD) card, a receiver wirelessly coupled to an external server, and combinations thereof (Para.0014 "The system can have a mobile device in wireless communication with the server system." and para.0143 "The data storage module can store the sensed data measurements, calculated fill levels, and parameters for operating the sensor. The communications module can communicate with an external device, such as a remote server system").
Regarding claims 30-33 and 36-37, Christensen teaches: the processing unit is configured to be activated when the lid is coupled to the body; record a time of activation when the lid is coupled to the body, and record a duration of time that the lid is coupled to the body; the processing unit is configured to determine the status by comparing the data to a predetermined threshold; and sending a message to an external server via a wireless communication interface when a VOC is measured by the one or more sensors (Para.0012 "The method can include attaching a time of determination (e.g., a time stamp) in a data set with the fill level and the identity of the one of the containers." and para.0085 "The time, date, length, and amount of opening from the lid controller can be recorded by the sensor as part of the sensor data or communicated directly from the lid controller to the server system (e.g., over a wired or wireless connection)."; Para.0029 "The threshold level for the alert can be altered based on other sanitation issues (e.g., [] decomposition rate or smells or detected fumes or gasses - such as detected by humidity, gas, pH detectors, or combinations thereof, in the sensor)"; and Abstract "The systems can have a sensor in the container in data communication with a server system").
Regarding claim 34, Christensen teaches positioning a biological tissue in the interior volume of the body (Para.0162 "For example, the server system can manage containers that include mixed household waste, portable toilets, septic tanks, and biohazard containers" suggests that biological tissues may be placed in the container).
Regarding claim 35, Christensen teaches recording any obtained VOC measurements from the one or more sensors, and any displayed indications of the one or more indicators; and transmitting the recorded VOC measurements and displayed indications to a second processing unit (Para.0131 "The processor can execute software, for example, installed during manufacture and/or downloaded from the server system" suggests recording and transmitting measurements between systems).
Claim 22 rejected under 35 U.S.C. 103 as being unpatentable over Christensen et al. (WO-2019040946) as applied to claims 21, 23-24, 26, and 30-37 above, and further in view of Fleming et al. (US-10092905).
Christensen et al. are applied to claims 21, 23-24, 26, and 30-37.
Regarding claim 22, Christensen teaches the method of Claim 21 on which this claim depends.
Christensen does not explicitly teach the interior compartment of the body is configured to house one or more biological tissues.
However, Fleming teaches the interior compartment of the body is configured to house one or more biological tissues (Page 15 col 1 lines 16-19 "The present disclosure relates generally to a tissue sample container, and in particular, to a tissue sample container configured to maintain the given orientation and identity of a tissue sample within the container.").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Christensen as taught by Fleming in order to monitor environmental conditions of the tissue over time (page 16 col 2 lines 8-12 "It is further desirable to have a tissue container that allows for time, temperature, and PH monitoring. Also, it is desirable to have a container with an identifier or label that can be tracked and traced during transportation, such as a smart container."). One skilled in the art would have a reasonable expectation of success because both approaches involve containers having an interior compartment that may be monitored.
Claim 25 rejected under 35 U.S.C. 103 as being unpatentable over Christensen et al. (WO-2019040946) as applied to claims 21, 23-24, 26, and 30-37 above, and further in view of Mahurin et al. (US-20050045493).
Christensen et al. are applied to claims 21, 23-24, 26, and 30-37.
Regarding claim 25, Christensen teaches the method of Claim 21 on which this claim depends.
Christensen does not explicitly teach the sensing unit is configured to detect volatile organic compounds (VOCs) in an amount from about 1 ppb to about 60,000 ppb.
However, Mahurin teaches a nominal detection limit of a gas detection system is in the ppb range (Para.0043 "From FIG. 5a, the gas detection system exhibits a sensitivity of 30 nF/ppm to acetone vapor. Capacitance variances as low as 0.1 nF are easily measured with relatively simple electronics, in contrast to the attofarad capacitance variances measured using the polymer based capacitive sensor. Thus, the inventive gas detection system described here has a nominal detection limit that is in the ppb range, which is a significant improvement over polymer based dielectric systems.").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Christensen as taught by Mahurin in order to periodically measure diverse environments for various VOCs based on the capacitances of the sensor(s) (Para.0040 "The inventive gas detector/system can be used in industrial settings, research labs, and natural environment by placing the sensing unit 5 or array of sensing units in the environment and periodically measuring the capacitances of the sensing unit(s). Then, the data points can be analyzed and compared with the background/blank data and the data banks" and Mahurin suggests all manner of housing for the disclosed chemical vapor detection apparatus in para.0027 "The sensing unit 5 can use a variety of configurations to form an electrochemical capacitor having substantially similar performance characteristics. The housing 25 may be unitary, i.e., one piece, or comprised of various components or elements, i.e., multi-piece. The material used for the housing 25 is electrically nonconductive and sufficiently contains the ionic liquid 20, maintaining electrical communication between the ionic liquid and the electrodes. In one embodiment, as shown in FIG. 3a and also in FIG. 1, the ionic liquid 20 and the electrodes 35 are disposed in the recessed area 30 of a unitary housing 25 which is made of a nonconductive material. Nonconductive materials that may be used for the housing 25 for the different embodiments of the present invention include polymers such as polypropylene, Teflon and polyethylene. Other nonconductive materials that may also be used include alumina and glass"). One skilled in the art would have a reasonable expectation of success because both approaches are concerned with monitoring the contents of a container.
Claims 27-29 and 38 rejected under 35 U.S.C. 103 as being unpatentable over Christensen et al. (WO-2019040946) as applied to claims 21, 23-24, 26, and 30-37 above, and further in view of Karnik et al. (US-20190082968).
Christensen et al. are applied to claims 21, 23-24, 26, and 30-37.
Regarding claims 27-29 and 38, Christensen teaches the method of Claims 21 and 34 on which this claim depends.
Christensen does not explicitly teach: the indicator comprises at least one light emitting diode (LED); the at least one LED displays one or more colors when a VOC is measured; nor the one or more colors comprise at least first, second and third colors.
However, Karnik teaches a device having an interface containing LEDs to provide indications to the user upon detection of a data event (Para.0076 "In some exemplary embodiments, wearable device 101 may further include additional user interface elements such as light emitting devices or LEDs 119 to provide indications to the user.").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Christensen as taught by Karnik in order to provide indications to the user (Para.0076 "In some exemplary embodiments, wearable device 101 may further include additional user interface elements such as light emitting devices or LEDs 119 to provide indications to the user."). One skilled in the art would have a reasonable expectation of success because both inventions are using sensors that would have information conveyed to a user.
Response to Arguments under 35 USC § 103
Applicant’s arguments filed 11/24/2025 are fully considered but they are not persuasive.
Applicant argues that Christensen is non-analogous art (Remarks 11/24/2025 pages 5-6). Applicant further argues that "there is nothing in any of the cited references that would motivate one of ordinary skill in the art to combine the teachings of these references to produce the presently claimed invention" (Remarks 11/24/2025 page 7). Examiner disagrees, and notes that while Christensen does not suggest using trash cans for tissue sample monitoring, it does suggest monitoring degradation of the contained material and alerting based on detected gasses, which is reasonably pertinent to the problem Applicant is addressing with the disclosed invention (para.0029 "The threshold level for the alert can be altered based on other sanitation issues (e.g., [] decomposition rate or smells or detected fumes or gasses").
Applicant argues a lack of motivation to combine Christensen and Mahurin (Remarks 11/24/2025 pages 6-8). Examiner notes the motivation previously discussed (above in section regarding 35 USC 103), and additionally notes that Mahurin suggests all manner of housing for the disclosed chemical vapor detection apparatus (para.0027 "The sensing unit 5 can use a variety of configurations to form an electrochemical capacitor having substantially similar performance characteristics. The housing 25 may be unitary, i.e., one piece, or comprised of various components or elements, i.e., multi-piece. The material used for the housing 25 is electrically nonconductive and sufficiently contains the ionic liquid 20, maintaining electrical communication between the ionic liquid and the electrodes. In one embodiment, as shown in FIG. 3a and also in FIG. 1, the ionic liquid 20 and the electrodes 35 are disposed in the recessed area 30 of a unitary housing 25 which is made of a nonconductive material. Nonconductive materials that may be used for the housing 25 for the different embodiments of the present invention include polymers such as polypropylene, Teflon and polyethylene. Other nonconductive materials that may also be used include alumina and glass").
Applicant argues that Examiner has used hindsight reasoning to arrive at the claimed inventions using the cited references (Remarks 11/24/2025 pages 8-9). Applicant asserts that "the devision to combine the VOC sensor of Mahurin with the smart trash can of Christensen to arrive at the claimed invention could only have been made with hindsight bias and ex post reasoning" and that "the Examiner has taken features from unrelated references, rearranged the features to be in the exact configuration of the claimed invention, and done so without any teaching, suggestion or motivation shown in the art" (Remarks 11/24/2025 pages 8-9). Examiner notes the profuse teachings and suggestions laid out in the section above regarding 35 USC 103, as well as the arguments directly above within this section, that clearly cite how Christensen is reasonably pertinent to the problem of the instant application, as well as motivation for combining the VOC sensor of Mahurin with the container of Christensen.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the TH REE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this finaI action.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert A. Player whose telephone number is (571)272-6350. The examiner can normally be reached Mon-Fri, 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs can be reached on 571-270-3062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.A.P./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686