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 .
This action is in response to papers filed Dec. 03, 2025. The amendments have been thoroughly reviewed and entered. Any previous objection/ rejection not repeated herein has been withdrawn.
Applicant's arguments have been thoroughly reviewed but are deemed moot in view of the amendments, withdrawn rejections and new grounds for rejection. New and/or modified grounds for rejection, necessitated by the amendments, are discussed.
Drawings
Corrected drawing The drawings were received on Dec. 03, 2025. These drawings are acceptable.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Crum et al., (US 2017/0320054; hereinafter “Crum”), including support reference What are RFID Tags/UHF Tags Explained (see https://www.atlasrfidstore.com/rfid-resources/what-are-rfid-tags-uhf-tags-explained and https://rfid.it/en/content/12-types-of-memory-in-rfid-tags#epc, both accessed on Jan. 15, 2026).
Regarding claim 1, Crum discloses a container 422 for collecting, transporting and storing a biological tissue sample of a human or animal (see para [0250] et seq.), wherein the container comprises a tag 422 with a receiver for receiving data relating to the biological tissue sample, a non-volatile memory for storing the data received by the receiver and a transmitter for transmitting the data stored by the memory. Specifically, Crum discloses the detection devices 442 include radio-frequency identification UHF RFID tags with a small metallic antenna and a silicon chip, and can be active or passive. The information content of an RFID tag can be fixed or changeable. The RFID tags can communicate information to the communication device 452. Additionally or alternatively, the detection devices 442 can include sensing elements (e.g., temperature sensor that measure the measure a temperature of the tissue sample) or can be in communication with sensing devices carried by the containers 422. The communication device 452 can be in the form of an RFID code reader, which are well known in the art and typically include an antenna and a transceiver that receives information from the RFID tag. Because the communication device 452 is physically coupled to the container 410, the communication device 452 can remain in communication with the tag throughout shipping (see para [0251] et seq.)
As discussed in length in the support articles cited above, it is well known that a basic UHF RFID tag is comprised of an antenna and the IC (as set forth in Crum at para [0251] et seq.)
Antenna – A tag’s antenna is unique to that specific type of tag and its job is to receive RF waves, energize the IC, and then backscatter the modulated energy to the RFID antenna.
Integrated Circuit (IC)/Chip – the integrated circuit, also called the chip, contains four memory banks, processing information, send and receive information, and anti-collision protocols. Each IC type is unique, and there are only a handful of manufacturers. The main variation between ICs is the number of bits in the respective memory banks.
The four memory banks are as follows:
EPC Memory Bank – contains the Electronic Product Code which can vary in length from 96 to 496 bits. Some manufacturers use a randomized, unique number, while others use random repeating numbers.
User Memory Bank – the User memory bank can range from 32 bits to over 64k bits and is not included on every IC. If the tag does possess a User memory bank, it can be used for user defined data about the item. This could be information like item type, last service date, or serial number. Many RFID tags, particularly high-memory ones, offer an additional User Memory bank. The user Memory bank is clearly present in the RFID used in Crum since this separate non-volatile memory area designed to store more detailed information beyond a simple ID number, such as:
Manufacturing dates
Maintenance or service logs
Sensor data (temperature, humidity)
Shipment or transaction details
Reserved Memory Bank – the Reserved memory bank contains the access and lock passwords which enable the tag memory to be locked by the user and require a password to view or edit.
TID Memory Bank – the TID memory bank contains the Tag Identifier which is a randomized, unique number that is set by the manufacturer and cannot be changed, kill password protected. In order for the reader to read this number instead of the EPC, the reader settings must be changed to accommodate.
Thus, clearly the RFID used in Crum includes at four separate non-volatile memory sections (i.e., known in the art as memory banks). At least two of these can store first data and second data, wherein at least two of the memory sections/banks are configured to lock the respective data independently from the data of the respective other memory section.
Regarding claims 2 and 17, the contents (fixative, fluid, etc) of the container are not considered part of the claimed device structure and are therefore not given patentable weight. For apparatus claims, if the prior art structure is capable of performing the intended use, then it meets the claim. Apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. The manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim (see MPEP § 2114 & § 2173.05(g)).
Nevertheless, in the interest of compact prosecution, the examiner notes that Crum does disclose the container is filled with a fixative and a liquid (i.e., phase change material (see para [0017] et seq.) Note the since the contents are not given patentable weight then whether or not the liquid has a lower specific gravity than the fixative and is immiscible with the fixative such that the component is stratified on top of the fixative has not been considered.
Regarding claim 3, the “data” is not considered part of the invention and has not received patentable weight. Nevertheless Crum discloses the data relating to the biological tissue sample includes a time stamp, wherein the time stamp is configured to relate to a fixation of the biological tissue sample contained in the container, in particular configured to indicate the beginning of fixation of the biological tissue sample contained in the container, wherein, preferably, the time stamp comprises a date, wherein the time stamp optionally comprises a fraction of the date, such as an hour and preferably a minute and more preferably a second, and/or wherein the time stamp optionally comprises a time zone and/or a format of time (see para [0273] et seq.).
Regarding claim 4, while the memory banks in the RFID have received patentable weight, the data stored in the memory banks is not considered part of the container structure and therefore has not received patentable weight. Nevertheless, Crum discloses an RFID which is known to include four banks of memory, Crum teaches these data includes a patient identifier and the fixative inside the container (see para [0314] et seq.)
Regarding claim 5, the RFID tag used in Crum is like all RFID tags in that it includes at least two memory banks that encrypt the data and/or protect the data by a password (see teaching reference above).
Regarding claim 6, Crum discloses the tag comprises a RFID (see para [0251] et seq.)
Regarding claim 7, Crum discloses further including a barcode (see para [0086] et seq.)
Regarding claim 8, Crum discloses the container, a transmitting unit for sending data to be received by the receiver of the container and then stored in the memory of the container and a reading unit for reading data transmitted by the transmitter of the container (Crum discloses the communication device 452 can be in the form of an RFID code reader, which are well known in the art and typically include an antenna (transmitter) and a transceiver receiver that receives information from the RFID tag (see para [0251] et seq.)
Regarding claim 9, Crum discloses a control unit (controller 450) functionally connected to the transmitting unit and the reading unit (see para [0251] et seq.)
Regarding claim 10, Crum discloses the control unit (450) is configured to receive a signal indicating the presence of the container and, upon receiving the signal, to activate the transmitting unit in order to send, by the transmitting unit, data to the container (see para [0251] et seq.)
Regarding claim 11, Crum inherently discloses a user interface (on/off button) configured to generate the signal.
Regarding claim 12, again, the “data” is not considered part of the invention and has not received patentable weight. Nevertheless Crum discloses the data relating to the biological tissue sample includes a time stamp, wherein the time stamp is configured to relate to a fixation of the biological tissue sample contained in the container, in particular configured to indicate the beginning of fixation of the biological tissue sample contained in the container, wherein, preferably, the time stamp comprises a date, wherein the time stamp optionally comprises a fraction of the date, such as an hour and preferably a minute and more preferably a second, and/or wherein the time stamp optionally comprises a time zone and/or a format of time (see para [0273] et seq.)
Regarding claims 13 and 18, Crum discloses comprising a visual reading unit 452 (see para [0251], the communication device 452 can be in the form of an RFID code reader, which are well known in the art and typically include an antenna and a transceiver that receives information from the RFID tag) for reading a visual tag comprised by the container and generated a signal upon reading the visual tag to transmit this signal to the control unit as the signal indicating the presence of the container (see para [0117] et seq.)
Regarding claim 14, Crum discloses a base 410 on which the container can be placed, wherein the base comprises at least part of the transmitting unit (see para [0249] et seq.)
Regarding claim 15, Crum discloses a) providing the container 422 according to b) transmitting, by a transmitting unit, data relating to a biological tissue sample, c) receiving the data by the receiver of the container and d) storing the data received by the receive by the receiver (the RFID on the container itself has a receiver and transmitting unit, see para [0251] et seq.)
Regarding claim 16, Crum discloses that before step a), the step of placing the biological tissue sample in the container (see para [0012] et seq.)
Regarding claim 19, Crum discloses a wall 2404 extends from the base (bottom of carrier assembly 2218) so as to extend on a lateral side of the container 2302 when the container is placed on the base, wherein the wall comprises at least one of at least part of the transmitting unit 2406.
Regarding claim 20, Crum disclose the wall comprises at least part of the visual reading unit 2406, wherein the wall comprises an opening, wherein the visual reading unit is arranged to read a visual tag via the opening (see para [0215] et seq. and Figs. 4a-c) The data logger 2406 of the carrier assemblies 2218 record and monitor temperature excursions against exemplary preprogrammed thresholds (e.g., but not limited to, heating, and/or freezing, etc.), about which can be indicated with an exemplary display such as, e.g., but not limited to, a LED/LCD display with exemplary warning(s). .
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Response to Arguments
Applicant's arguments filed Dec. 03, 2025 have been fully considered but they are not persuasive. In response to the previous 102 rejection under Crum applicant argues neither an RFID (tag) cannot be a non-volatile memory to store data received by receiver, as recited by amended claim 1, and cannot be the first or second memory section. The examiner respectfully disagrees. The original claim 1 was unclear and could have been interpreted to mean two different types of memory, RFID and barcode type. However, after the amendment by applicant the memory sections have been interpreted by the examiner as part of the RFID tag alone, which as discussed in the support references are inherent in RFID tags. Clearly the RFID tags used in Crum include the inherent four separate non-volatile memory sections (i.e., known in the art as memory banks). At least two of these can store first data and second data, wherein at least two of the memory sections/banks are configured to lock the respective data independently from the data of the respective other memory section. The four memory sections/banks are fundamental components of RFID tags, see above. Thus, for the reasons delineated above, the claims remain rejected over the Crum reference.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Visinoni et al., (US 2016/0157837) which disclose a container (1) for collecting, transporting and storing biological tissue samples, wherein the container (1) is filled with a first component (3) being a fixative and a second component (4) being a fluid, wherein the second component (3) has a lower specific gravity compared to the fixative (3), and is immiscible with the fixative (3). The second component (4) is stratified on top of the fixative (3) to form a protective film to prevent fixative fumes to escape from the container (1). The invention further relates to a method for collecting, transporting and storing biological tissue samples. The method comprises the steps of: filling a first component (3) being a fixative in a container (1), and filling a second component (4) being a fluid in the container (1) filled with the first component (3), wherein the second component (4) has a lower specific gravity compared to the fixative (3) and is immiscible with the fixative (3) so that the second component (4) is stratified on top of the fixative (3) to form a protective film to prevent fixative fumes to escape from the container (1). The method further comprises the, step of placing a biological tissue sample into the first component (3) before or after the second component (4) has been filled into the container (1).
Berberich et al., (US 2014/0186882) which disclose a processing apparatus configured to automatically identify the target fixing time. For example, the target fixing time stored in the memory can be read out by a reading and/or writing means of the processing apparatus. The target fixing time can be written into the memory, for example, by another reading and/or writing means of the trimming station. Alternatively or additionally, the processing apparatus can determine the target fixing time based on at least one sample property. In particular, the processing apparatus can identify the target fixing time based on the conductivity of the sample and/or the volume of the sample and/or the weight of the sample and/or the sample density. Identification of the target fixing time can be accomplished automatically. The advantage of identification of the sample property by the processing apparatus is that it is possible to identify exactly when the fixing operation has ended.
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 THREE-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 final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached on 9:30am-7:30 pm EST.
Examiner interviews are available via telephone 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.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798