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 .
DETAILED ACTION
This action is in reference to the communication filed on 11 DEC 2025.
Applicant has elected Group I, claims 1-16, 20-22.
Applicant has Claims 1-16, 20-22are present and have been examined.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: sensor unit, recording unit, control device, and function restriction unit in claims 1, communication unit, recording unit, and information provider in claim 20. Claims 2, 6-14, 21, 22 recite these elements as well.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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 limitation “sensor unit, recording unit, control device, and function restriction unit” in claims 1, “communication unit, recording unit, and information provider” in claim 20 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Examiner notes claims 2, 6-14, 21, 22 recite these elements as well. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Examiner finds that the invoking terms as noted above are not sufficiently linked to appropriate structure to execute the claim(ed) functions of sensing, recording, controlling, information providing and restricting, as in exemplary claims 1, 20. Examiner further notes a lack of sufficient algorithm disclosure linking the functions to the claimed/identified terms. While some structure exists or is present, the link itself is not clearly tied to the claimed function.
Therefore, claims 1-16, 20-22 is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Per MPEP 2181 IV:
“When a claim containing a computer-implemented 35 U.S.C. 112(f) claim limitation is found to be indefinite under 35 U.S.C. 112(b) for failure to disclose sufficient corresponding structure (e.g., the computer and the algorithm) in the specification that performs the entire claimed function, it will also lack written description under section 112(a).”
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16, 20-22 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As described above, the disclosure does not provide adequate structure to perform the claimed function Claim limitation “sensor unit, recording unit, control device, and function restriction unit” in claims 1, “communication unit, recording unit, and information provider” in claim 20 (as well as similar terms in claims 1-16, 20-22) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
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.
Claim(s) 1-15, 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pleshek et al (US 20150029001 A1, hereinafter Pleshek) in view of Miura (JPH08-35889).
In reference to claim 1:
Pleshek teaches: A medical instrument control system comprising:
an accommodating container accommodating a medical instrument (at least [fig 1 and related text] “The interior compartment 18 is configured to house a plurality of items 26. In this regard, the interior compartment may include a plurality of sub-compartments 28, each of which is configured to house one or more individual items. By way of example, the items 26 may include pharmaceuticals, biologics, medical devices, such as implants, and/or related medical instruments, e.g., surgical instruments.”);
a sensor unit that acquires environmental information obtained at the time of transportation of the accommodating container (at least [fig 2 and related text] “ In some embodiments, the sensor(s) 54 may include one or more sensors for monitoring environmental conditions, such as temperature, humidity, atmospheric pressure, etc., of the internal compartment and/or the ambient conditions surrounding the mobile RFID container “);
a recording unit that records the environmental information acquired by the sensor unit (at least [fig 2 and related text as well as 014] “ Data, such as scan (i.e., RFID tag data), location, sensed parameter and/or time code data may be communicated to a remote device such as an enterprise resource planning ("ERP") system, website, server, personal computer, etc. The remote device may use the data received from the transportable container to automatically update and generate appropriate records (e.g., container inventory, restocking, invoicing, location tracking, breakage, tampering, container conditions, open and close events, etc.).)”; and
a control device that is connected to the medical instrument and controls functions of the medical instrument (at least [fig 2 and related text] “ The controller 46 may be operatively coupled to the sensor(s) 54 and configured to collect data from the sensor(s). In some embodiments, the controller 46 may be configured to perform additional actions, such as triggering one or more RFID scans, in response to the sensor data. For example, in embodiments where the sensor(s) 54 include a door sensor, the controller 46 may be configured to trigger one or more RFID scans in response to a door sensor indicating the door has been closed. In some embodiments, the controller may be configured to trigger scans when the sensor data meets a predetermined condition, such as a predetermined temperature or humidity condition.…The controller 46 may be configured to trigger RFID scans via the RFID detector 42 and to transmit scan data to the remote device 41 via the communications interface 44. In some embodiments, the controller 46 may transmit the scan data to the remote device 41 each time an RFID scan is performed. In some embodiments, the controller may be configured to trigger one or more RFID scans in response to a scan request received from the remote device 41. In some embodiments, the controller 46 may be configured to trigger multiple scans. For example, the controller 46 may run a plurality of scans in order to ensure a predetermined integrity level of the scan data in the manner described in the aforementioned U.S. Pat. No. 8,025,288.)” see also [040] “The controller 46 may be configured to control the locking mechanism 59 in response to data collected from the identification sensor 61 indicating that an entity, e.g., person or business, is (or is not) authorized to access the contents of the container. The controller 46 may further be configured to transmit data gathered from the identification sensor to a remote device. For example, in some embodiments, the controller may be configured to record identity information regarding entities who attempt to access contents of the container via the identification sensor and transmit such data (alone or with other data such as contemporaneous scan and/or parameter data) to the remote device.” – controller controls the access, i.e. function of the device itself). Pleshek as cited teaches wherein access to the medical device itself is prohibited or allowed based on access credentials, as well as disclosing that the device is medical device specifically, but does not specifically disclose function restriction based on environmental information. Miura however does teach:
wherein the control device has a function restriction unit that restricts the functions of the medical instrument based on the environmental information recorded in the recording unit (at least [005-7] “If the temperature and humidity of the main parts that specify transportation environment conditions etc. are not within the allowable environment temperature and humidity, a message to that effect is displayed and the use of the device is stopped if necessary. It is an object to provide an electronic device….In order to achieve the above object, the present invention provides means for detecting the temperature and / or humidity on the surface of the device and its surroundings, and whether or not the device can be used depending on the output from this detecting means. First and second determining means are provided for determining whether the device is unusable by comparing it with the first determining value and notifying that effect, and comparing with the second determining value and using the device. When it is determined to be impossible This is notified and the device is stopped.”). Pleshek and Miura are analogous references as both disclose a means of monitoring conditions during the transport and/or use of an electronic device. Pleshek at least contemplates that due to collected information (i.e. the scanned/authorization information) the function of the device itself may be impeded or allowed, and further contemplates the detected atmospheric information may be relayed to prevent damage, and as such it would have obvious to one of ordinary skill in the art to limit functionality of the device based on ambient conditions as taught by Miura, specifically as Miura teaches this could potentially limit permanent damage to the unit itself.
In reference to claim 2:
Pleshek teaches: Wherein the function restriction unit restricts the functions of the medical instrument based on authorization information (at least [040] locking mechanism activated based on the authorization of a person who has access to the contents), as well as taking an action when a temperature exceeds a predetermined threshold value (at least [033-035] “ In some embodiments, the controller may be configured to trigger scans when the sensor data meets a predetermined condition, such as a predetermined temperature or humidity condition.”), and identification information of the medical instrument. Pleshek however does not specifically teach restricting based on the environmental information. Miura however does teach: restricting based on the result of comparison between the environmental information associated with identification information of the medical instrument and a predetermined threshold value (at least [005-7] “If the temperature and humidity of the main parts that specify transportation environment conditions etc. are not within the allowable environment temperature and humidity, a message to that effect is displayed and the use of the device is stopped if necessary. It is an object to provide an electronic device….In order to achieve the above object, the present invention provides means for detecting the temperature and / or humidity on the surface of the device and its surroundings, and whether or not the device can be used depending on the output from this detecting means. First and second determining means are provided for determining whether the device is unusable by comparing it with the first determining value and notifying that effect, and comparing with the second determining value and using the device. When it is determined to be impossible This is notified and the device is stopped.”). The combination of Pleshek/Miura with regard to environmental restriction is similar as in claim 1 and as such the motivation to combine is incorporated therein.
In reference to claim 3:
Pleshek further teaches: Wherein the predetermined threshold value is a value of an environmental element set to guarantee the quality of the medical instrument at the time of transportation or at the time of storage (at least [033-035] “The controller 46 may also be configured to transmit data if the controller detects an event that could adversely affect the RFID-tagged items, such as an excessive impact or adverse temperature condition.”).
In reference to claim 4:
Pleshek further teaches: Wherein the predetermined threshold value is a value set based on a threshold value of the environmental element set at the time of use of the medical instrument (at least [033-035] “…predetermined temperature or humidity condition.”).
In reference to claim 5:
Pleshek/Miura teaches all the limitations above. Miura further teaches: Wherein when the environmental information at the time of transportation exceeds the predetermined threshold value, the authorization information indicates that the use of the medical instrument is not permitted (at least [005-7] “If the temperature and humidity of the main parts that specify transportation environment conditions etc. are not within the allowable environment temperature and humidity, a message to that effect is displayed and the use of the device is stopped if necessary. It is an object to provide an electronic device….In order to achieve the above object, the present invention provides means for detecting the temperature and / or humidity on the surface of the device and its surroundings, and whether or not the device can be used depending on the output from this detecting means. First and second determining means are provided for determining whether the device is unusable by comparing it with the first determining value and notifying that effect, and comparing with the second determining value and using the device. When it is determined to be impossible This is notified and the device is stopped.”), and
when the environmental information at the time of transportation does not exceed the predetermined threshold value, the authorization information indicates that the use of the medical instrument is permitted (at least [006] “First and second determining means are provided for determining whether the device is unusable by comparing it with the first determining value and notifying that effect, and comparing with the second determining value and using the device.” at [014/page 2] “On the other hand, if TX <T2 in step 45, it can be judged that the temperature is within the temperature limit specification value of the device and the device can be used continuously…”). The motivation to include authorization and control based on ambient conditions as taught by Miura in the medical equipment use of Pleshek is similar to that of claim 1 above and is therefore incorporated by reference.
In reference to claim 6:
Pleshek further teaches: Wherein the recording unit is provided in a server, the server includes (at least [0026, fig 1 and related text] server in EPS 41) :
a communication unit that receives the environmental information acquired by the sensor unit (at least [fig 2 and related text] Communication interface 44 receives information from sensors 54 via controller 46); and
a recording processing unit that records the received environmental information in the recording unit in association with the identification information of the medical instrument (at least [026] “The interior compartment 18 is configured to house a plurality of items 26. In this regard, the interior compartment may include a plurality of sub-compartments 28, each of which is configured to house one or more individual items. By way of example, the items 26 may include pharmaceuticals, biologics, medical devices, such as implants, and/or related medical instruments, e.g., surgical instruments. Each product (or its packaging) may include one or more RFID tags 30 (see FIG. 2) encoded with descriptive information for the respective product, such as an EPC code, a TID code, a serial number, a product type, a date, a lot number, and similar information, or a unique ID, among other information which can correspond to information in a database on a server.” At [fig 2 and related text] sensors 54 collect information during the RFID scans),
the control device further includes:
an acquisition unit that acquires the identification information of the medical instrument scheduled to be used for a medical operation (at least [026] identification of inventory of instruments, at [044-047] procedure based acquisition of expected instruments to be used). Pleshek as cited teaches restricting the access to a given set of instruments based on an acquired information (see 040) matching with the stored information for access to the instruments, but does not specifically teach restriction based on environmental information. Miura however does teach:
the function restriction unit restricts the functions of the medical instrument based on the environmental information recorded in association with the acquired identification information in the server (at least [005-7] “If the temperature and humidity of the main parts that specify transportation environment conditions etc. are not within the allowable environment temperature and humidity, a message to that effect is displayed and the use of the device is stopped if necessary. It is an object to provide an electronic device….In order to achieve the above object, the present invention provides means for detecting the temperature and / or humidity on the surface of the device and its surroundings, and whether or not the device can be used depending on the output from this detecting means. First and second determining means are provided for determining whether the device is unusable by comparing it with the first determining value and notifying that effect, and comparing with the second determining value and using the device. When it is determined to be impossible This is notified and the device is stopped.”). The combination of Pleshek/Miura with regard to environmental restriction is similar as in claim 1 and as such the motivation to combine is incorporated therein.
In reference to claim 7:
Pleshek further teaches: a reader that reads the environmental information acquired by the sensor unit, wherein the reader transmits the read environmental information to the server (at least [figs 2, 4 and related text] communication interface sends data from sensors 54 to ERP system/remote device 41 including one or more servers).
In reference to claim 8:
Pleshek further teaches: Wherein the sensor unit has a communication unit that transmits the acquired environmental information to the server (at least [fig 2 and related text] “The communications interface 44 may be a wireless communications interface and may include one or more of a cellular interface, a Wi-Fi interface or a Bluetooth interface, for example.”).
In reference to claim 9:
Pleshek further teaches: Wherein the sensor unit is provided in the accommodating container and holds the identification information of the medical instrument accommodated in the accommodating container (at least [014, 019, 042, fig 2 and related text] RFID container includes sensors, sensor/RFID container includes current container inventory); and
the communication unit in the server receives the environmental information acquired by the sensor unit and the identification information of the medical instrument held by the sensor unit (at least [fig 2 and related text, as well as 045] “ The scan data is then transmitted (Step 530) to the remote device 41 where it can be used to generate and/or update appropriate records (e.g., container inventory, discrepancies, locations, restocking, invoicing, other recordable events, etc.). (See, e.g., Steps 540-550). The mobile RFID container 10 may also transmit location data with the scan data to allow the remote device to coordinate the current inventory of the mobile RFID container with its location. “).
In reference to claim 10:
Pleshek further teaches: wherein the accommodating container accommodates a plurality of the medical instruments (at least [026] “The interior compartment 18 is configured to house a plurality of items 26. In this regard, the interior compartment may include a plurality of sub-compartments 28, each of which is configured to house one or more individual items. By way of example, the items 26 may include pharmaceuticals, biologics, medical devices, such as implants, and/or related medical instruments, e.g., surgical instruments. Each product (or its packaging) may include one or more RFID tags 30 (see FIG. 2) encoded with descriptive information for the respective product, such as an EPC code, a TID code, a serial number, a product type, a date, a lot number, and similar information, or a unique ID, among other information which can correspond to information in a database on a server.”), and
the sensor unit holds the identification information of the plurality of medical instruments accommodated in the accommodating container (at least [fig 2 and related text] sensors 54, and controller 46 maintains information from RFID scans).
In reference to claim 11:
Pleshek further teaches: Wherein the sensor unit holds the identification information of the sensor unit (at least [fig 2 and related text] sensor unit 54),
the communication unit in the server receives the environmental information acquired by the sensor unit and the identification information of the sensor unit held by the sensor unit (at least [fig 2 and related text, as well as 045] “ The scan data is then transmitted (Step 530) to the remote device 41 where it can be used to generate and/or update appropriate records (e.g., container inventory, discrepancies, locations, restocking, invoicing, other recordable events, etc.). (See, e.g., Steps 540-550). The mobile RFID container 10 may also transmit location data with the scan data to allow the remote device to coordinate the current inventory of the mobile RFID container with its location. “), and
the recording unit in the server records the identification information of the medical instrument and the environmental information in association with the identification information of the sensor unit (at least [026] “The interior compartment 18 is configured to house a plurality of items 26. In this regard, the interior compartment may include a plurality of sub-compartments 28, each of which is configured to house one or more individual items. By way of example, the items 26 may include pharmaceuticals, biologics, medical devices, such as implants, and/or related medical instruments, e.g., surgical instruments. Each product (or its packaging) may include one or more RFID tags 30 (see FIG. 2) encoded with descriptive information for the respective product, such as an EPC code, a TID code, a serial number, a product type, a date, a lot number, and similar information, or a unique ID, among other information which can correspond to information in a database on a server.” At [fig 2 and related text] sensors 54 collect information during the RFID scans).
In reference to claim 12:
Pleshek further teaches: wherein the recording unit is provided in the medical instrument and records the identification information of the medical instrument and the environmental information transmitted from the sensor unit (at least [026] “The interior compartment 18 is configured to house a plurality of items 26. In this regard, the interior compartment may include a plurality of sub-compartments 28, each of which is configured to house one or more individual items. By way of example, the items 26 may include pharmaceuticals, biologics, medical devices, such as implants, and/or related medical instruments, e.g., surgical instruments. Each product (or its packaging) may include one or more RFID tags 30 (see FIG. 2) encoded with descriptive information for the respective product, such as an EPC code, a TID code, a serial number, a product type, a date, a lot number, and similar information, or a unique ID, among other information which can correspond to information in a database on a server.” At [fig 2 and related text] sensors 54 collect information during the RFID scans),
the control device acquires the identification information of the medical instrument and the environmental information recorded in the recording unit from the medical instrument (at least [026] identification of inventory of instruments, at [044-047] procedure based acquisition of expected instruments to be used)
Pleshek as cited teaches restricting the access to a given set of instruments based on an acquired information (see 040) matching with the stored information for access to the instruments, a well as restricting the access to certain instruments to an authorized user per se, but does not specifically teach restriction based on environmental information. Miura however does teach:
the function restriction unit determines whether or not to restrict the functions of the medical instrument based on the identification information of the medical instrument and the environmental information. (at least [005-7] “If the temperature and humidity of the main parts that specify transportation environment conditions etc. are not within the allowable environment temperature and humidity, a message to that effect is displayed and the use of the device is stopped if necessary. It is an object to provide an electronic device….In order to achieve the above object, the present invention provides means for detecting the temperature and / or humidity on the surface of the device and its surroundings, and whether or not the device can be used depending on the output from this detecting means. First and second determining means are provided for determining whether the device is unusable by comparing it with the first determining value and notifying that effect, and comparing with the second determining value and using the device. When it is determined to be impossible This is notified and the device is stopped.”). The combination of Pleshek/Miura with regard to environmental restriction is similar as in claim 1 and as such the motivation to combine is incorporated therein.
In reference to claim 14:
Pleshek further teaches: wherein the sensor unit is provided for each medical instrument (at least [026] “By way of example, the items 26 may include pharmaceuticals, biologics, medical devices, such as implants, and/or related medical instruments, e.g., surgical instruments. Each product (or its packaging) may include one or more RFID tags 30 (see FIG. 2) encoded with descriptive information for the respective product, such as an EPC code, a TID code, a serial number, a product type, a date, a lot number, and similar information, or a unique ID, among other information which can correspond to information in a database on a server.”)
In reference to claim 20:
Pleshek teaches: A management server capable of communicating with a control device connected to a medical instrument, comprising:
a communication unit that receives environmental information obtained at the time of transportation of an accommodating container that accommodates the medical instrument (at least [fig 2 and related text, as well as 045] “ The scan data is then transmitted (Step 530) to the remote device 41 where it can be used to generate and/or update appropriate records (e.g., container inventory, discrepancies, locations, restocking, invoicing, other recordable events, etc.). (See, e.g., Steps 540-550). The mobile RFID container 10 may also transmit location data with the scan data to allow the remote device to coordinate the current inventory of the mobile RFID container with its location. “ at [fig 1 and related text] “The interior compartment 18 is configured to house a plurality of items 26. In this regard, the interior compartment may include a plurality of sub-compartments 28, each of which is configured to house one or more individual items. By way of example, the items 26 may include pharmaceuticals, biologics, medical devices, such as implants, and/or related medical instruments, e.g., surgical instruments.”);
a recording unit that records the received environmental information in association with identification information of the medical instrument (at least [026] “The interior compartment 18 is configured to house a plurality of items 26. In this regard, the interior compartment may include a plurality of sub-compartments 28, each of which is configured to house one or more individual items. By way of example, the items 26 may include pharmaceuticals, biologics, medical devices, such as implants, and/or related medical instruments, e.g., surgical instruments. Each product (or its packaging) may include one or more RFID tags 30 (see FIG. 2) encoded with descriptive information for the respective product, such as an EPC code, a TID code, a serial number, a product type, a date, a lot number, and similar information, or a unique ID, among other information which can correspond to information in a database on a server.” At [fig 2 and related text] sensors 54 collect information during the RFID scans); and
an information provider that provides authorization information to the control device when the information provider receives an inquiry regarding the medical instrument having the identification information from the control device, (at least [040] locking mechanism activated based on the authorization of a person who has access to the contents), as well as taking an action when a temperature exceeds a predetermined threshold value (at least [033-035] “ In some embodiments, the controller may be configured to trigger scans when the sensor data meets a predetermined condition, such as a predetermined temperature or humidity condition.”), and identification information of the medical instrument. Pleshek however does not specifically teach restricting based on the environmental information. Miura however does teach: the authorization information is generated based on the environmental information associated with the identification information or the result of comparison between the environmental information and a predetermined threshold value (at least [005-7] “If the temperature and humidity of the main parts that specify transportation environment conditions etc. are not within the allowable environment temperature and humidity, a message to that effect is displayed and the use of the device is stopped if necessary. It is an object to provide an electronic device….In order to achieve the above object, the present invention provides means for detecting the temperature and / or humidity on the surface of the device and its surroundings, and whether or not the device can be used depending on the output from this detecting means. First and second determining means are provided for determining whether the device is unusable by comparing it with the first determining value and notifying that effect, and comparing with the second determining value and using the device. When it is determined to be impossible This is notified and the device is stopped.”).
Pleshek and Miura are analogous references as both disclose a means of monitoring conditions during the transport and/or use of an electronic device. Pleshek at least contemplates that due to collected information (i.e. the scanned/authorization information) the function of the device itself may be impeded or allowed, and further contemplates the detected atmospheric information may be relayed to prevent damage, and as such it would have obvious to one of ordinary skill in the art to limit functionality of the device based on ambient conditions as taught by Miura, specifically as Miura teaches this could potentially limit permanent damage to the unit itself.
In reference to claim 21:
Pleshek further teaches: wherein the communication unit receives the environmental information from a reader that has read the environmental information acquired by a sensor unit (at least [fig 2 and related text] RFID Reader 50 receives sensor data 54 via controller 46).
In reference to claim 22:
Pleshek further teaches: Wherein the communication unit receives the environmental information from a sensor unit that has acquired the environmental information (at least [fig 2 and related text] Communication interface 44 receives information from sensors 54 via controller 46).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pleshek et al (US 20150029001 A1, hereinafter Pleshek) in view of Miura (JPH08-35889), further in view of Official Notice.
In reference to claim 16:
Pleshek further teaches medical instruments within the container (at least [026] “he interior compartment 18 is configured to house a plurality of items 26. In this regard, the interior compartment may include a plurality of sub-compartments 28, each of which is configured to house one or more individual items. By way of example, the items 26 may include pharmaceuticals, biologics, medical devices, such as implants, and/or related medical instruments, e.g., surgical instruments. Each product (or its packaging) may include one or more RFID tags 30 (see FIG. 2) encoded with descriptive information for the respective product, such as an EPC code, a TID code, a serial number, a product type, a date, a lot number, and similar information, or a unique ID, among other information which can correspond to information in a database on a server. The sub-compartments 28 may be defined by a substantially RF transparent material, such as hard foam; plastic or rigid cardboard.”) Further, at [044-046] Pleshek teaches wherein the inventory is checked after a procedure in order to either replace inventory of medical instruments and/or supplies, or for invoicing purposes. As Pleshek teaches wherein the medical instrument may be a single use surgical instrument, it would have been obvious to one of ordinary skill in the art that the single use instrument be a single use endoscope.
Non-Obvious Subject Matter
Claims 13, 15 are believed to be free of the prior art. While Pleshek discloses that the instruments may travel, and discloses maintaining an inventory of the instruments, the references as cited do not fairly disclose the change in routes or the alternate suggestions of routes/permissions in view of the detected real time environmental conditions as found in claims 13, 15.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2021/0060243 to Dave discloses a means of controlling movement of medical devices in a surgical environment.
US 2020/0405311 to Shelton discloses compatibility of medical devices and restricting use without, based on identification and tracking of the devices.
Conclusion
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687