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 1-7 in the reply filed on 03/26/2026 is acknowledged. Further, it is noted applicant has canceled claims 8-12 and have added new claims, 13-22, which are encompassed by Group I of the instant application.
Preliminary Remarks
Applicant has canceled claims 8-12, and have added claims 13-22 of the instant application. Therefore, claims 1-7 and 13-22 remain pending in the application.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-3, 5-6, and 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over by US 2016/0095310 A1-Anderson et al (hereinafter “Anderson”).
Regarding claim 1, Anderson teaches a hypothermic tissue transport system (para. [0032], lines 1-4) comprising: a tissue container (transport container 10, para. [0043], line 3, Fig. 1); at least one temperature sensor operable to provide temperature information for an interior cavity of the tissue container (temperature sensor 40, para. [0049], lines 2-3, Fig. 1). However, Anderson does not explicitly teach a positioning transmitter.
For claim 1, a different embodiment of Anderson teaches a positioning transmitter (positioning receiver, para. [0013], line 11), which reads on the instant claim limitation of a positioning transmitter.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a positioning transmitter as taught by a different embodiment of Anderson, because another embodiment of Anderson teaches a positioning transmitter allows for real-time tracking of the position of the container (para. [0013], lines 11-13).
Regarding claim 1, Anderson teaches the invention discussed above. Further, Anderson teaches a temperature sensor, also discussed above. Further, another embodiment of Anderson teaches a positioning transmitter, also discussed above. However, Anderson does not explicitly teach a computer device and an output device.
For claim 1, another embodiment of Anderson teaches the use of mobile devices (smartphones), tablets (para. [0083], lines 1-4), which reads on the instant claim limitation of a computer device.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a computer device as taught by another embodiment of Anderson, because Anderson teaches the temperature can be wirelessly communicated to a second display on the exterior of the second transport container (para. [0020], lines 5-8). Further, another embodiment of Anderson teaches the temperature sensor may also be connected to a processor which will compare the measured temperature to a threshold or range; the alert may comprise an audible tone, or may signal to a networked device, e.g., a computer, cell phone, or pager that the temperature within the container exceeds the desired threshold or range. (para. [0051], lines 12-19).
Regarding claim 2, Anderson teaches the invention discussed above in claim 1. However, Anderson does not explicitly teach at least one of a pressure sensor, an oxygen sensor, an accelerometer, and a clock.
For claim 2, a different embodiment of Anderson teaches a suite of sensors measures temperature, oxygen content, and pressure of the circulating fluids (para. [0012], lines 10-12), which reads on the instant claim limitation of at least one of a pressure sensor, an oxygen sensor, an accelerometer, and a clock.
It would have been obvious to one of ordinary skill, in the art at the time, to further include at least one of a pressure sensor, an oxygen sensor, an accelerometer, and a clock as taught by another embodiment of Anderson, because another embodiment of Anderson teaches the system will have sensors and displays to monitor conditions in addition to temperature, for example oxygen flow, oxygen consumption, or pressure (para. [0015], lines 6-9). Also, another embodiment of Anderson teaches displays for additional relevant information, such as time since harvest, pressure inside the first transport container, partial pressure of oxygen, or oxygen consumption rate of the biological sample (para. [0074], lines 16-19). Moreover, another embodiment of Anderson teaches a suite of sensors measures temperature, oxygen content, and pressure of the circulating fluids to assure that the tissue experiences a favor able environment during the entire transport (para. [0012], lines 10-13).
Regarding claim 3, Anderson discloses wherein the tissue is cardiac, epidermal, pulmonary, neurologic, nephrologic, or hepatic tissue (the system includes a first transport container configured to suspend a biological sample (e.g., tissue or an organ, para. [0013], lines 1-3), further, Anderson discloses the invention is intended for the transport of biological samples, generally, which may include tissues, organs, body fluids, and combinations thereof, para. [0035], lines 8-11).
Regarding claim 5, Anderson discloses a wireless data transmitter (temperature display 45 may be coupled to the temperature sensor 40 using any suitable method, for example a wire, cable, connector, or wirelessly using available wireless protocols, para. [0050], lines 11-14).
Regarding claim 6, Anderson discloses wherein the wireless data transmitter uses a protocol selected from the group consisting of 3G, 4G, 4G LTE, 5G, WIFI, BlueTooth, WirelessHD, WiGig, Z-Wave, or Zigbee (temperature display 45 may be coupled to the temperature sensor 40 using any suitable method, for example a wire, cable, connector, or wirelessly using available wireless protocols, para. [0050], lines 11-14).
Regarding claim 13, Anderson discloses wherein the tissue container is hermetically sealed (the canister 32 are coupled such that the organ chamber 30 is hermetically sealed, para. [0052], lines 4-6).
Regarding claim 14, Anderson discloses wherein the tissue container contains a preservation fluid configured to surround a tissue during transport (a desired amount of preservation fluid is introduced into the organ chamber 30, para. [0052], lines 6-7).
Regarding claim 15, Anderson discloses wherein at least one temperature sensor is disposed in contact with the preservation fluid (a desired amount of preservation fluid is introduced into the organ chamber 30, para. [0052], lines 6-7; further, Fig. 1 shows temperature sensor 40 disposed in contact with chamber 30, which comprises preservation fluid, as previously discussed).
Regarding claim 16, Anderson discloses wherein the tissue container comprises at least one recess configured to receive a cooling medium (the system also includes a second transport container having an insulated cavity for receiving the first transport container, and having recesses for receiving cooling media, para. [0013], lines 6-9).
Regarding claim 17, Anderson discloses wherein the cooling medium comprises one or more eutectic cooling blocks (the cooling media will be one or more eutectic cooling blocks, para. [0015], lines 1-2).
Regarding claim 18, Anderson discloses wherein the computer device is configured to generate an alert when a measured temperature is outside a predetermined temperature range (the temperature sensor may also be connected to a processor which will compare the measured temperature to a threshold or range and create an alert signal when the temperature exceeds the threshold or range, para. [0040], lines 12-15).
Regarding claim 19, Anderson discloses wherein the output device comprises a mobile device, tablet, desktop computer, or pager (a networked device, e.g., a computer, cellphone, or pager, para. [0040], lines 16-17; a number of options for receiving and displaying the information from the system are available, including direct networks, webpages, dummy terminals, mobile devices (smartphones), tablets, pagers, and smart watches, para. [0083], lines 1-4).
Regarding claim 20, Anderson teaches the invention discussed above in claim 1. Further, Anderson teaches a transmitter of the system, also discussed above. Also, hypothermic teaches a tissue transport system. However, Anderson does not explicitly teach flight-tracking.
For claim 20, a different embodiment of Anderson teaches flight-tracking of the system (para. [0082], line 15), which reads on the instant claim limitation of flight-tracking.
It would have been obvious to one of ordinary skill, in the art at the time, to further include flight-tracking, as taught by a different embodiment of Anderson, because Anderson teaches the system is configured to sense when it has moved into a shielded environment, e.g., inside an aircraft or airport; the system is configured to sense when it is no longer able to access the network, at which point the system will switch to flight-tracking to allow the receiving medical team to know the position of the system in real time (para. [0082], lines 11-16).
Regarding claim 21, Anderson discloses wherein the computer device is configured to display historical case data (the temperature display 45 can be any display suit able for displaying a temperature measured by the temperature sensor 40, or otherwise providing information about the temperature within the pulsatile first transport container 10, para. [0051], lines 1-4; the first transport container has a temperature sensor and a temperature display, it will be possible for the medical professional to monitor the temperature of the sample, para. [0078], lines 9-13).
Regarding claim 22, Anderson discloses wherein the computer device is configured to display at least one of a minimum, a maximum, or an average temperature recorded during a session (the temperature sensor may also be connected to a processor which will compare the measured temperature to a threshold or range and create an alert signal when the temperature exceeds the threshold or range; the alert may comprise an audible tone, or may signal to a net worked device, e.g., a computer, cellphone, or pager that the temperature within the container exceeds the desired thresh old or range, para. [0040], lines 12-19).
Claims 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0095310 A1-Anderson et al (hereinafter “Anderson”) as applied to claim 1 above, and further in view of US 8,389,280 B2-Taylor et al (hereinafter “Taylor”).
Regarding claim 4, Anderson teaches the invention discussed above in claim 1. Further, Anderson teaches a hypothermic tissue transport system, also discussed above. However, Anderson does not explicitly teach a global positioning system (GPS) transmitter.
For claim 4, Taylor teaches an invention directed to an apparatus and method for perfusing an organ to monitor, sustain and/or restore the viability of the organ, for transporting and/or storing the organ (col. 2, lines 45-48) and Taylor teaches a global positioning system may be added to transporter (col. 12, lines 38-39), which reads on the instant claim limitation of a global positioning system (GPS) transmitter.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a global positioning system (GPS) transmitter as taught by Taylor, because Taylor teaches the GPS allows for the facilitation of tracking of the organ (col. 12, lines 38-39) and an interface allows perfusion parameters, vascular resistance, and organ identification and transporter and cassette location to be tracked and displayed in real-time or captured for future analysis (col. 12, lines 43-46).
Regarding claim 7, Anderson teaches the invention discussed above in claim 5. Further, Anderson teaches a hypothermic tissue transport system, also discussed above. Further, Anderson teaches a wireless data transmitter, also discussed above. However, Anderson does not explicitly teach wherein the wireless data transmitter is a direct satellite data transmitter.
For claim 7, Taylor teaches an invention directed to an apparatus and method for perfusing an organ to monitor, sustain and/or restore the viability of the organ, for transporting and/or storing the organ (col. 2, lines 45-48) and Taylor teaches a global positioning system may be added to transporter (col. 12, lines 38-39), where a GPS is known in the art to be a satellite-based navigation system, and which reads on the instant claim limitation of a direct satellite data transmitter.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a direct satellite data transmitter as taught by Taylor, because Taylor teaches the GPS allows for the facilitation of tracking of the organ (col. 12, lines 38-39) and an interface allows perfusion parameters, vascular resistance, and organ identification and transporter and cassette location to be tracked and displayed in real-time or captured for future analysis (col. 12, lines 43-46).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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