DETAILED ACTION
Response to Amendment
This action is in response to the amendment filed on July 9, 2026. Claims 1-6, 8, and 10-13 have been amended. Claims 7 and 9 have been cancelled. Claims 14-22 have been added. Claims 1-6, 8, and 10-22 have been examined and are currently pending.
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 .
Inventorship
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.
Information Disclosure Statement
The Information Disclosure Statement filed on July 9, 2026 has been considered. An initialed copy of the Form 1449 is enclosed herewith.
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 1-6, 8, and 10-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
ALICE/ MAYO: TWO-PART ANALYSIS
2A. First, a determination whether the claim is directed to a judicial exception (i.e., abstract idea).
Prong 1: A determination whether the claim recites a judicial exception (i.e., abstract idea).
Groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Mathematical concepts- mathematical relationships, mathematical formulas or equations, mathematical calculations.
Certain methods of organizing human activity- fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
Mental processes- concepts performed in the human mind (including an observation, evaluation, judgement, opinion).
Prong 2: A determination whether the judicial exception (i.e., abstract idea) is integrated into a practical application.
Considerations indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception
Considerations that are not indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
2B. Second, a determination whether the claim provides an inventive concept (i.e., Whether the claim(s) include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)).
Considerations indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception NOTE: The only consideration that does not overlap with the considerations indicative of integration into a practical application associated with step 2A: Prong 2.
Considerations that are not indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. NOTE: The only consideration that does not overlap with the considerations that are not indicative of integration into a practical application associated with step 2A: Prong 2.
See also, 2019 Revised Patent Subject Matter Eligibility Guidance; Federal Register; Vol. 84, No. 4; Monday, January 7, 2019
Claims 1-6, 8, and 10-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
1: Statutory Category
Applicant’s claimed invention, as described in independent claim 1 is directed to a method.
2(A): The claim(s) are directed to a judicial exception (i.e., an abstract idea).
PRONG 1: The claim(s) recite a judicial exception (i.e., an abstract idea).
Certain Methods of Organizing Human Activity
Independent claim 1 recites the limitations, "loading a transportation and storage device with a baseline inventory of at least one medical device, each medical device including an RFID tag and a QR code; shipping the transportation and storage device including the baseline inventory to a healthcare facility; tracking a location of the transportation and storage device relative to the healthcare facility; scanning an inventory of the transportation and storage device with an RFID scanner periodically to transmit RFID data; monitoring the RFID data to detect any change in the inventory of the transportation and storage device relative to the baseline inventory; identifying any medical device missing from the baseline inventory of the transportation and storage device based on the monitored RFID data; scanning a QR code of any medical device used during a surgical procedure at the healthcare facility with a barcode scanner; cross-referencing the monitored RFID data and the scanned QR code to verify the identity of any missing medical device as being that used in the surgical procedure; automatically shipping a replacement medical device in response to the cross-referenced verification based on the tracked location of the transportation and storage device; and replenishing the inventory of the transportation and storage device with the replacement medical device to reestablish the baseline inventory at the healthcare facility." are directed to the abstract idea of commercial or legal interactions under certain methods of organizing human activity. Specifically, the limitations are directed to business relations and sales activities with respect to inventory usage/tracking and replenishment of medical devices.
PRONG 2: The judicial exception (i.e., an abstract idea) is not integrated into a practical application.
The applicant's limitations are not "integrated into a practical application" because they are adding words "apply it" with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea (see MPEP 2106.05(f)). The claim recites the elements of a “medical device”, “transportation and storage device,” “RFID scanner”, and “barcode scanner” to perform the abstract idea. The claim does not include additional elements or limitations individually or in combination that are sufficient to amount to significantly more than the judicial exception. Specifically, the individual element of a medical device, transportation and storage device, RFID scanner, and barcode scanner amount to no more than implementing an idea with a computerized system and they are adding words "apply it" with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea. The additional elements taken in combination add nothing more than what is present when the elements are considered individually. Therefore, based on the two-part Alice Corp. analysis, there are no meaningful limitations in the claims that transform the exception (i.e., abstract idea) into a patent eligible application.
2(B): The claims do not provide an inventive concept (i.e., The claim(s) do not include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)). As discussed with respect to Step 2A Prong Two, the additional element(s) in the claim amounts to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
For these reasons, there is no invention concept in the claim, and thus the claim is ineligible.
Dependent claims 2-6, 8, and 10-22 are rejected as ineligible subject matter under 35 U.S.C. 101 based on a rationale similar to the claims from which they depend. Dependent claims 2 and 21 recite "mobile application", dependent claims 3-4, 10, 16-18 recite "medical devices", dependent claims 5-6, 11 and 13-14 recite "transportation and storage device", dependent claims 11-12 recite “replacement medical device”, dependent claim 14 recites “monitor”, “display screen”, “touch screen”, “environmental sensor”, and “security feature” and dependent claim 15 recites “display screen”. Dependent claims 2-6, 10-18 and 21 do not recite additional elements that amount to significantly more than the judicial exception.
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.
Claim(s) 1-2, 5-6, 10, and 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Pleshek et al. US Publication 20150029001 A1 in view of WO 2016/040593 A1 (hereinafter “DeBusk”) in view of Shelton, IV et al. US Publication 20240001416 A1 in view of Sayani et al. US Publication 20180204323 A1 further in view of Catchings et al. US Publication 20200143930 A1.
Claim 1:
As per claim 1, Pleshek teaches a method comprising:
tracking a location of the transportation and storage device relative to the healthcare facility (paragraphs 0010, 0019, 0034, and 0043 “The container may also include a location device for determining the location of the container and its associated cargo. For example, the container may utilize cellular triangulation and/or global positioning system ("GPS") technology to allow for determining the location of the container.” and “The method may also comprise generating location data indicative of the location of the mobile RFID container and transmitting location data from the mobile RFID container to the remote device.”);
scanning an inventory of the transportation and storage device with an RFID scanner periodically to transmit RFID data (paragraphs 0018, 0030, and 0035 “In some embodiments, the controller may be configured to trigger an RFID scan via the RFID detector in response to the occurrence of predetermined events and/or at regular time intervals. For example, the controller may be configured to trigger an RFID scan in response to the door sensor detecting that the door has been closed. The controller may further be configured to transmit the scan data to a remote device.” and “The controller 46 may be configured to store the scan data, sensor data and/or location data in memory carried by the container 10. The controller 46 may further be configured to transmit the scan data and/or sensor data to a remote device. For example, in some embodiments, the controller 46 may be configured to transmit the scan data and/or sensor data at predetermined time intervals and/or in response to predetermined events or conditions. In this regard, the controller 46 may automatically transmit scan data each time a scan occurs, e.g., in response to the container being accessed. 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.”);
monitoring the RFID data to detect any change in the inventory of the transportation and storage device relative to the baseline inventory (paragraph 0044 “…FIG. 5 is a flow diagram illustrating certain aspects of an exemplary process for distributing items from the mobile RFID container during a surgical procedure. In step 505, the mobile RFID container 10 is opened. For example, the field representative may open the mobile RFID container at the beginning of the surgical procedure or at such time as may be deemed appropriate. Next, in step 510, one or more items are removed from (and/or added) to the container during the medical procedure. For example, several devices, e.g., implants of varying sizes, may be removed from the container. During medical procedure, the appropriate device(s) may be implanted and unused devices may be return to or left in the container. While the container 10 is at the end user, it may perform one or more RFID scans to collect scan data (i.e., RFID tag data) concerning its contents. For example, an RFID scan may be automatically triggered when the door is closed following the medical procedure.”);
identifying any medical device missing from the baseline inventory of the transportation and storage device based on the monitored RFID data (paragraphs 0044-0045 “…FIG. 5 is a flow diagram illustrating certain aspects of an exemplary process for distributing items from the mobile RFID container during a surgical procedure. In step 505, the mobile RFID container 10 is opened. For example, the field representative may open the mobile RFID container at the beginning of the surgical procedure or at such time as may be deemed appropriate. Next, in step 510, one or more items are removed from (and/or added) to the container during the medical procedure. For example, several devices, e.g., implants of varying sizes, may be removed from the container. During medical procedure, the appropriate device(s) may be implanted and unused devices may be return to or left in the container. While the container 10 is at the end user, it may perform one or more RFID scans to collect scan data (i.e., RFID tag data) concerning its contents. For example, an RFID scan may be automatically triggered when the door is closed following the medical procedure.” and “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. For example, the data may be used to determine what items were used during the surgery for invoicing purposes.”);
Pleshek does not teach loading a transportation and storage device with a baseline inventory of at least one medical device, each medical device including an RFID tag and a QR code. However, DeBusk teaches a System for Tracking Utilization and Consumption of Medical Items in a Medical Facility and Maintaining a Chain of Custody based thereon and further teaches, “Each medical item has a unique item identifier encoded in a machine-readable code in an RFID tag, a QR code, a bar code, or a combination thereof attached to the medical item or its wrapper. In some embodiments, an RFID tag and a QR code are combined in a single label applied to the medical item or its wrapper.” (paragraph 0065) And “As the term is used herein, a “shipment” of medical items comprises multiple medical items, of the same type or different types, that are packaged together at a supplier location and shipped to a location at which the medical items are consumed or dispensed. Generally, each shipment includes a packing list that lists all of the medical items in the shipment. In preferred embodiments, each packing list has a unique shipment identifier that encodes shipment identification information that is specific to the shipment. The shipment identifier may be in the form of an RFID tag, bar code, or other encoded identifier attached to, embedded in, or printed on the packing list.” (paragraph 0071) and “FIGS.23-25 depict a system for tracking medical items through various transition points in a supply and consumption chain. Unless otherwise defined herein, the term“supplier” generally refers to a medical item manufacturer or distributor or any other entity that ships medical items to a medical facility to be put into inventory. As shown in FIG.23, each shipment 54 of medical items 38 from a supplier typically includes a packing list 56 that has a unique shipment identifier 58 encoded in an RFID tag and/or a bar code attached to the packing list or attached to a container in which the medical items 38 are shipped. Upon packing of medical items 38 at a supplier facility for shipment (first transition point), a unique item identifier 39 encoded in an RFID tag and/or a bar code attached to each packed medical item 38 and the unique shipment identifier 58 are read by one or more reading devices 59 at the supplier facility and are cross-referenced in a supplier inventory database 60.” paragraph 00116. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek to include loading a transportation and storage device with a baseline inventory of at least one medical device, each medical device including an RFID tag and a QR code as taught by DeBusk in order to provide a variety of identifiers associated with an item.
Pleshek does not teach shipping the transportation and storage device including the baseline inventory to a healthcare facility. However, DeBusk teaches a System for Tracking Utilization and Consumption of Medical Items in a Medical Facility and Maintaining a Chain of Custody based thereon and further teaches, “As the term is used herein, a “shipment” of medical items comprises multiple medical items, of the same type or different types, that are packaged together at a supplier location and shipped to a location at which the medical items are consumed or dispensed. Generally, each shipment includes a packing list that lists all of the medical items in the shipment. In preferred embodiments, each packing list has a unique shipment identifier that encodes shipment identification information that is specific to the shipment. The shipment identifier may be in the form of an RFID tag, bar code, or other encoded identifier attached to, embedded in, or printed on the packing list.” (paragraph 0071) and “Unless otherwise defined herein, the term “supplier” generally refers to a medical item manufacturer or distributor or any other entity that ships medical items to a medical facility to be put into inventory. As shown in FIG.23, each shipment 54 of medical items 38 from a supplier typically includes a packing list 56 that has a unique shipment identifier 58 encoded in an RFID tag and/or a bar code attached to the packing list or attached to a container in which the medical items 38 are shipped.” (paragraph 00116) and “Upon receipt of the shipment 54 of medical items at the medical facility (second transition point), the unique shipment identifier 58 of the packing list 56 is read and decoded by one or more reading devices 62, and the unique shipment identifier is stored in the medical facility inventory database 52 in association with a unique personnel identifier 65 of the person responsible for receiving the shipment of medical items at the medical facility.” (paragraph 00117). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek to include shipping the transportation and storage device including the baseline inventory to a healthcare facility as taught by DeBusk in order to supply medical devices to the healthcare facility.
Pleshek and DeBusk do not teach scanning a QR code of any medical device used during a surgical procedure at the healthcare facility with a barcode scanner. However, Shelton teaches a System for Determining Disposal of Surgical Instrument and Related Methods and further teaches, “Surgical instrument (5040) may also include a QR code (5048). QR code (5048) may contain suitable data required to identify the specific instrument (5040) along with various suitable information related to the specific instrument (5040) (such as a geographical location in which instrument (5040) was sold and/or sent).” (paragraph 0069) and “In some instances, the application running disposal assistance device (5050) may be configured to connect to a hub (106) that was used in conjunction with instrument (5040) during a surgical procedure. Such an application may have limited permissions with hub (106) such that the staff utilizing disposal assistance device (5050) and the corresponding application do not have access to any portion of hub (106) aside from relevant disposal instructions, cleaning, and/or sterilization information. Such connection between hub (106) and the application of device (5050) may allow device (5050) to communicate with interconnected hospital systems for operating room system/inventory tracking, etc. Therefore, once instrument (5040) or other suitable instruments/components are used in a surgery and scanned by device (5050), hub (106) may update the inventory of the hospital system to recognize use of instruments (5040) and/or other components. It should be understood that being “scanned” by device (5050) may include device (5050) utilizing camera (5056) to scan QR code (5048); establishing a connection between communication modules (5046, 5056); or any other suitable form of device (5050) obtaining data from instrument (5040) as would be apparent to one skilled in the art in view of the teachings herein.” (paragraph 0074). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek and Debusk to include scanning a QR code of any medical device used during a surgical procedure at the healthcare facility with a barcode scanner as taught by Shelton in order to track medical device usage during a surgery.
Pleshek, DeBusk, and Shelton do not teach cross-referencing the monitored RFID data and the scanned QR code to verify the identity of any missing medical device as being that used in the surgical procedure. However, Sayani teaches a Detection of Surgical Instruments on Surgical Tray and further teaches, “In general, a computing server is described that can determine whether any surgical instruments are missing on a surgical tray, and, if one or more instruments are missing, identify those missing one or more instruments. In one aspect, at least one computing server can receive, from a camera device, a matrix code and a bitmap of an image of a tray having a first plurality of instruments. The at least one computing server can detect the tray based on the matrix code. The at least one computing server can receive, from a database associated with the at least one computing server, a preset list of a second plurality of instruments configured to be stored in the detected tray. The at least one computing server can detect the first plurality of instruments stored in the tray by using the bitmap. The at least one computing server can compare the preset list of the second plurality of instruments with the detected first plurality of instruments to generate an output characterizing whether one or more instruments are missing from the tray and an identification of the one or more instruments when the one or more instruments are missing from the tray. The at least one computing server can transmit the output to a computing device.” (paragraph 0004), “FIG. 1 illustrates a system 100 for determining whether any surgical instruments 102 are missing on a surgical tray 104, and if one or more instruments 102 are missing identifying those missing one or more instruments 102. The system 100 can include a camera device 106, at least one computing server 108, and a database 110 operably coupled to the at least one computing server 108. The camera device 106 can take a bitmap of the surgical instruments 102 in the tray 104 along with the matrix barcode (for example, a quick response (QR) code) of the tray 104. The at least one computing server 108 can use the bitmap to detect instruments 102 currently present in the tray 104, and use the matrix barcode to retrieve from the database 110 a list of instruments 102 that should be present in the tray. The at least one computing server 108 can compare the detected instruments 102 with the list of instruments 102 that should be present to determine whether any surgical instruments 102 are missing on a surgical tray 104, and if one or more instruments 102 are missing identification(s) of those missing one or more instruments 102. The at least one computing server 108 can be operably coupled to a computing device 112, which can execute a graphical user interface 114 configured to display whether any surgical instruments 102 are missing on a surgical tray 104, and if one or more instruments 102 are missing identification of those missing one or more instruments 102.” (paragraph 0019) and “Although a matrix code is described above, other implementations may use a barcode or a radio frequency identification (RFID) tag.” (paragraph 0022). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek, Debusk, and Shelton to include cross-referencing the monitored RFID data and the scanned QR code to verify the identity of any missing medical device as being that used in the surgical procedure as taught by Sayani in order to determine medical devices that have been used.
Pleshek, DeBusk, Shelton, and Sayani do not teach automatically shipping a replacement medical device in response to the cross-referenced verification based on the tracked location of the transportation and storage device. However, Catchings teaches a Surgical Product Supply System and Method and further teaches, “The system 100 is also preferably able to determine a first consumed product set based on the comparison of the second RFID tag content information and the first RFID tag content information, specifically when the comparison of the second RFID tag content information reveals that there are less RFID tags 220 identified in the second RFID tag content information in comparison to the first RFID tag content information. This preferably results in the system 100 identifying the missing RFID tags 220, which can be correlated to particular packages 230 and surgical items 210, as consumed or used between the first scan and the second scan. The system 100 is also able to notify the remote server 180 of the first consumed product set and direct an inventory system to deliver a first replacement product set associated with the first consumed product set to the first compartment 110…” (paragraph 0067). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek, DeBusk, Shelton, and Sayani to include automatically shipping a replacement medical device in response to the cross-referenced verification based on the tracked location of the transportation and storage device as taught by Catchings in order to supply the healthcare facility with a minimum amount supply of medical devices.
Pleshek, DeBusk, Shelton, and Sayani do not teach and replenishing the inventory of the transportation and storage device with the replacement medical device to reestablish the baseline inventory at the healthcare facility. However, Catchings teaches a Surgical Product Supply System and Method and further teaches, “If there are RFID tags 220 in the second RFID tag content information which were not in the first RFID tag content information, additional or new packages 230 and surgical items 210 were added to the first compartment 110 between the first scan and the second scan. If there are RFID tags 220 in the first RFID tag content information that were not in the second RFID tag content information, certain of the packages 230 and surgical items 210 were consumed and the system 100 is able to identify which of the packages 230 and surgical items 210 were consumed so that the consumed packages 230 and surgical items 210 can be reordered and inserted into the first compartment 110. Each of the compartments 110, 120, 130, 140 can be similarly scanned and analyzed to identify, collect and store information regarding the plurality of surgical items 201 and packages 230 that are within the compartments 110, 120, 130, 140 at any particular time and to compare the RFID tag content information at different times to track additions, consumption and replenishment of the packages 230 and surgical items 201 associated with the system 100.” (paragraph 0065) and “In the preferred embodiment, the first and second RFID antenna arrays 151, 152 are configured to periodically scan the first plurality of surgical items 201 to determine a first number of surgical items 210 that are in the first plurality of surgical items 201. The first and second RFID antenna arrays 151, 152 preferably periodically scan the first storage area 111 to track the first number of surgical items 210 to determine if any of the items 210 are missing, have been used or additional items 210 have been added since a previous scan. The periodic scanning assists the preferred surgical product supply system 100 in maintaining inventory control of the first plurality of surgical items 210 for several reasons, such as for replenishment of items 210 that are used or for planning purposes to track the frequency of item 210 use.” (paragraph 0042). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek, DeBusk, Shelton, and Sayani to include and replenishing the inventory of the transportation and storage device with the replacement medical device to reestablish the baseline inventory at the healthcare facility as taught by Catchings in order to supply the healthcare facility with a minimum amount supply of medical devices.
Claim 2:
As per claim 2, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above and Sayani further teaches wherein cross-referencing the monitored RFID data with the QR code is performed using a mobile application (paragraphs 0019 and 0022). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Pleshek to include wherein cross-referencing the monitored RFID data with the QR code is performed using a mobile application as taught by Haapoja in order maintain accurate records with respect to products and their corresponding identifications.
Claim 5:
As per claim 5, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above and Pleshek further teaches further comprising scanning the RFID tags of the transportation and storage device when a case of the transportation and storage device is opened or closed (paragraphs 0018 and 0033).
Claim 6:
As per claim 6, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above and Pleshek further teaches further comprising scanning the RFID tags of the transportation and storage device at predetermined time intervals or on demand (paragraph 0018).
Claim 10:
As per claim 10, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above and Catchings further teaches further comprising automatically generating an invoice in response to verifying the identity of any missing medical device used in the surgical procedure (paragraphs 0013 and 0058). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek, DeBusk, Shelton, and Sayani to include further comprising automatically generating an invoice in response to verifying the identity of any missing medical device used in the surgical procedure as taught by Catchings in order to bill or charge for products or medical devices used.
Claim 14:
As per claim 14, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above and Pleshek further teaches wherein the transportation and storage device includes at least one of:
a monitor, a display screen (paragraph 0013), a touch screen, an environmental sensor (paragraph 0032), and a security feature (paragraph 0040).
Claim 15:
As per claim 15, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 14 as described above and Catchings further teaches further comprising providing at least one of:
product information (paragraphs 0052 and 0066), a surgical technique guide, a teleconference, and a videoconference via the display screen. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek, DeBusk, Shelton, Sayani to include further comprising providing at least one of: product information, a surgical technique guide, a teleconference, and a videoconference via the display screen as taught by Catchings in order to have medical device information available for a user.
Claim 16:
As per claim 15, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above and Pleshek further teaches wherein the at least one medical device comprises an implant or an instrument (paragraphs 0003 and 0016).
Claim 17:
As per claim 17, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 16 as described above and Catchings further teaches wherein the at least one medical device includes screws of various sizes (paragraph 0039). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek, DeBusk, Shelton, and Sayani to include wherein the at least one medical device includes screws of various sizes as taught by Catchings in order to provide the medical professional options with respect to screws.
Claim 18:
As per claim 18, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above and Catchings further teaches further comprising redirecting inventory based on expiration date or recall data associated with the at least one medical device (paragraphs 0057 and 0069). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek, DeBusk, Shelton, and Sayani to include further comprising redirecting inventory based on expiration date or recall data associated with the at least one medical device as taught by Catchings in order to separate medical inventory is that not optimal from being used.
Claim 19:
As per claim 15, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above and Pleshek further teaches wherein the healthcare facility is a hospital (paragraph 0043), a surgery center (paragraph 0043), or an orthopedic care center.
Claim 20:
As per claim 20, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above and Catchings further teaches further comprising verifying inventory readiness or logistics prior to initiating the surgical procedure (paragraph 0006). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek, DeBusk, Shelton, and Sayani to include further comprising verifying inventory readiness or logistics prior to initiating the surgical procedure as taught by Catchings in order to ensure all the medical devices necessary for a surgical are available to be used.
Claim 21:
As per claim 21, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above and Catchings further teaches further comprising logging at least one of: facility location, patient information, used inventory (paragraph 0058), procedure type, and procedure date via a mobile application. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek, DeBusk, Shelton, and Sayani to include further comprising logging at least one of: facility location, patient information, used inventory as taught by Catchings in order to maintain a record of medical devices utilized.
Claim 22:
As per claim 22, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above and Catchings further teaches wherein a sales representative is not needed to perform at least one of: dropping-off inventory before a case, picking-up inventory after a case, and resupplying used inventory (paragraph 0067). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pleshek, DeBusk, Shelton, Sayani to include wherein a sales representative is not needed to perform at least one of: dropping-off inventory before a case, picking-up inventory after a case, and resupplying used inventory as taught by Catchings in order to generate labor savings and efficiency of supplying medical devices.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Pleshek, DeBusk, Shelton, Sayani, and Catchings as applied to claim 1 above, and further in view of Hunt et al. US Publication 20210228360 A1.
Claim 3:
As per claim 3, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above but do not teach wherein the medical devices are sterile packed screws for sacroiliac joint fusion. However, Hunt teaches Sacroiliac Joint Fusion Systems and Methods and further teaches, “The standard treatment for SI joint pain is a sacroiliac joint fusion. This procedure is designed to eliminate movement of the SI joint by fusing together the ilium and sacrum. Typically, sacroiliac fusion relies on the user of screws or rods that are implanted across the SI joint. The screws or rods hold the bones together allowing the bones to fuse.” (paragraph 0004). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Pleshek, DeBusk, Shelton, Sayani, and Catchings to include wherein the medical devices are sterile packed screws for sacroiliac joint fusion in order to access screws to perform the sacroiliac joint fusion procedure.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pleshek, DeBusk, Shelton, Sayani, and Catchings as applied to claim 1 above, and further in view of Katzman et al. US Publication 20140277165 A1.
Claim 4:
As per claim 4, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above but do not teach wherein the medical devices are sterile single use instruments for performing sacroiliac joint fusions. However, Katzman teaches Sacroiliac Joint Stabilization Method and further teaches, “Referring to FIG. 3, there is illustrated surgical kit 15 and the various instruments of the kit used to carry out the sacroiliac joint fusion procedure of the present invention. Kit 15 includes an enclosure 32 having a base and a removable lid. Contained within enclosure 32 are a set of at least four dilation tubes 36, a drill guide 38, a drill 40, a k-wire 42, an implant inserter 44, and optionally, a joint locator 41. Kit 15 may also include a bone fusion promoting substance such as bone morphogenetic protein-2 (BMP-2) or stem cell-containing material. Kit 15 may further include at least four sacroiliac joint implants or dowels 34 (including a pair of implants 28 for inferior insertion and a pair of implants 30 for superior insertion); however, in most instances, dowels 34 are stored and transported separately from kit 15.” (paragraph 0049). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Pleshek, DeBusk, Shelton, Sayani, and Catchings to include wherein the medical devices are sterile single use instruments for performing sacroiliac joint fusions as taught by Katzman in order to reduce the possibility of infections.
Claim(s) 8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Pleshek, DeBusk, Shelton, Sayani, and Catchings as applied to claim 1 above, and further in view of Sweeney et al. US Publication 20180303577 A1.
Claim 8:
As per claim 8, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above but do not teach wherein a sales representative or employee tags QR codes onsite to log specific inventory used in surgical procedure. However, Sweeney teaches an Integrated Surgical Implant Delivery System and Method and further teaches, “As another example, the usage module 421 may be configured to identify that a medical device has been used based on usage information manually entered by operating room personnel or sales staff. In response to tracking usage of a medical device, the usage module 421 is configured to generate usage data. For example, in some embodiments, the usage module 421 may generate a device usage ticket (“DUT”) when a medical device has been used such as in an operating room for a patient operation. In certain embodiments, the usage module 421 may also require hospital personnel, such as operating room doctors or staff, to sign or otherwise confirm the DUT (e.g., by electrically signing the DUT, by physically signing and scanning in the DUT, by clicking an acknowledgement box, etc.). The usage module 421 compiles the usage data and may be configured to share the usage data with other modules of the monitoring system 110. To illustrate, the usage module 421 may share the usage data with the inventory module 420, such that the inventory module 420 can update the inventory database 426.” (paragraph 0062) and “Process 550 includes detecting the use of the medical device (step 552). The use of the medical device may be detected in an operating room by a monitoring system. The medical device may include an RFID tag readable by an RFID reader, a bar code readable by a camera and monitoring system, or any other identifier configured to be readable by a monitoring system. In some implementations, the medical device usage may be determined based on manually entered usage information by operating room personnel or sales staff.” (paragraph 0097). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Pleshek, DeBusk, Shelton, Sayani, and Catchings to include wherein a sales representative or employee tags QR codes onsite to log specific inventory used in surgical procedure as taught by Sweeney in order to allow a user to be a part in the tracking of used inventory.
Claim 11:
As per claim 11, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 1 as described above but do not teach wherein the replacement medical device is shipped in real-time directly to the healthcare facility rather than returning the transportation and storage device to a manufacturer or a distribution center for refill. However, Sweeney teaches an Integrated Surgical Implant Delivery System and Method and further teaches, “…As another example, a hospital may communicate directly with a manufacturer of medical devices to receive a stock of the medical devices and to submit a purchase order when the hospital uses one or more of the medical devices. The manufacturer may then fulfill the order through a sales representative or distributor vendor, which provides the medical devices to the hospital…” (paragraph 0072). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Pleshek, DeBusk, Shelton, Sayani, and Catchings to include wherein the replacement medical device is shipped in real-time directly to the healthcare facility rather than returning the transportation and storage device to a manufacturer or a distribution center for refill as taught by Sweeney in order to fulfill the purchase order.
Claim 12:
As per claim 12, Pleshek, DeBusk, Shelton, Sayani, and Catchings teach the method of claim 11 as described above and Pleshek further teaches wherein GPS data is cross-referenced to ensure the replacement medical device is directed to the healthcare facility (paragraphs 0045-0046).
Claim 13:
As per claim 13, Pleshek, DeBusk, Shelton, Sayani, Catchings, and Sweeney teach the supply chain management system of claim 11 as described above and Sweeney further teaches wherein inventory replenishment associated with the transportation and storage device is performed locally by a sales representative or employee affiliated with the healthcare facility by adding scanned RFID tags to the inventory of the transportation and storage device (paragraphs 0112 and 0072). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Pleshek, DeBusk, Shelton, Sayani, and Catchings to include wherein inventory replenishment associated with the transportation and storage device is performed locally by a sales representative or employee affiliated with the healthcare facility by adding scanned RFID tags to the inventory of the transportation and storage device as taught by Sweeney in order to restock or replenish items in a timely fashion.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed July 9, 2026, with respect to the rejection(s) of claim(s) 1, 5-7 and 10 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Pleshek, DeBusk, Shelton, Sayani, and Catchings.
Objections to claims 5, 10, and 11 have been withdrawn.
Claims 11-13 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cambre et al. US Publication 20070001839 A1 Control System for an RFID-Based System for Assembling and Verifying Outbound Surgical Equipment Corresponding to a Particular Surgery
Cambre discloses a control system for an RFID-based system for assembling and verifying outbound surgical equipment corresponding to a particular surgery. A user enters a identification number of a surgery. The control system queries a database of surgery information and outputs a list of required surgical equipment, such as surgical instrument sets. An operator uses the list to pick instrument sets for loading into a shipping tote. Each set is tagged with an RFID inventory tag that stores identification information for that set such as a set name and ID number. The shipping tote is passed through an RFID reader and identification data read from the tags is compared against the identification data for sets required for that surgery. A status indicator is activated to alert a user as to whether the surgery is complete that is, all expected sets are present, or that exception handling is required. The control system updates a database such as an ERP system to reflect that the surgery including the required sets has shipped--and the sets are inventoried out to the intended recipient.
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 MATTHEW L HAMILTON whose telephone number is (571)270-1837. The examiner can normally be reached Monday-Thursday 9:30-5:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571)270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW L HAMILTON/Primary Examiner, Art Unit 3682
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