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 .
Claims 1-18 are pending. Claims 1-18 are rejected herein.
Priority
This application claims sufficient priority to provisional application 63/525,572 and has an effective fling date of 07 July 2023.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02 January 2026 has been entered.
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 1-18 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.
Claims 1,10 and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: The Statutory Categories
The claim recites a system, a method and a non-transitory computer program product storing instructions, which are all within a statutory category (or are interpreted to be within a statutory category for subject matter eligibility analysis purposes).
Step 2A Prong One: The Abstract Idea
The limitations of (claim 1 being representative) […] storing parameters corresponding to a surgical instrument of a system […]; adjusting, based on the received data set, the stored parameters; determining a graphical depiction characterizing the adjusted parameters; and […] displaying the graphical depiction of the adjusted parameters […] and generating a […] graphical depiction of the adjusted parameters […] as drafted, is a process that, under the broadest reasonable interpretation, covers performance of the limitation in the mind but for recitation of generic computer components.
Claim 1, 10 and/or 18 recites the following additional elements, which will be dealt with in turn: a manufacturer-sealed sterile surgical packaging containing a surgical instrument, a sensor comprising a circuit disposed on a first portion of the manufacturer-sealed sterile surgical packaging and a conductive element disposed on a second portion of the manufacturer-sealed sterile surgical packaging, a graphical display, at least one data processor, a memory storing instructions configured to cause the at least one processor to perform operations, and a non-transitory computer program product for storing instructions. The claim also recites the additional elements of “a control signal” (i.e. configured to display the graphical depiction […] on the graphical display) and “receiving a data set characterizing at least a physical historical event experienced by the manufacturer-sealed sterile surgical package, wherein the data set characterizes a breach of the manufacturer-sealed sterile surgical package indicated by the physical break of the circuit.”
Other than reciting additional elements that were instructions to apply the abstract idea with generic computer(s) and/or computer part(s) (a graphical display, at least one data processor, a memory, and a non-transitory computer program product for storing instructions) this claim encompasses a person thinking about storing parameters, receiving a data set related to the breakage of sterile surgical packaging, adjusting, based on the received data, the stored parameters; determining a graphical depiction characterizing the adjusted parameters; and providing the graphical depiction of the adjusted parameters in the manner described in the identified abstract idea, supra. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. The Examiner notes that a claim that requires a computer may still recite a mental process (see MPEP 2106.04(a)(2)). Accordingly, the claim recites an abstract idea.
Step 2A Prong Two: Practical Application
These judicial exceptions are not integrated into a practical application. In particular, the independent claims recite the additional elements of a graphical display, at least one data processor, a memory storing instructions configured to cause the at least one processor to perform operations, and a non-transitory computer program product for storing instructions that implements the identified abstract idea. These are not described by the applicant and are recited at a high-level of generality such that they amount to no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim further recites the additional element of “a control signal” (i.e. configured to display the graphical depiction on the graphical display). The control signal equates to saying “apply it.” MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
The claim further recites the additional element of an a manufacturer-sealed sterile surgical packaging containing a surgical instrument, a sensor comprising a circuit disposed on a first portion of the manufacturer-sealed sterile surgical packaging and a conductive element disposed on a second portion of the manufacturer-sealed sterile surgical packaging. These merely generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application.
The claim further recites the additional element of “receiving a data set characterizing at least a physical historical event experienced by the manufacturer-sealed sterile surgical package, wherein the data set characterizes a breach of the manufacturer-sealed sterile surgical package indicated by the physical break of the circuit.” MPEP 2106.05(g) Insignificant Extra Solution Activity indicates that when determining whether an additional element is insignificant extra-solution activity at Step 2A Prong Two, the examiner may consider the following: whether the limitation is significant (i.e., it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention) and whether the limitation amounts to necessary data gathering or output (i.e., all uses of the recited judicial exception require such data gathering or data output). The recited limitation does not impose meaningful limits on the claim such that it is not nominally or tangentially related to the invention and the limitation amounts to necessary data gathering. This same section of the MPEP indicates that mere data gathering is an activity that the courts have found to be insignificant extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a graphical display, at least one data processor, a memory storing instructions configured to cause the at least one processor to perform operations, and a non-transitory computer program product for storing instructions to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
The claim further recites the additional element of “a control signal” (i.e. configured to display the graphical depiction on the graphical display). This additional element equates to saying “apply it.” MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application or provide significantly more.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of a manufacturer-sealed sterile surgical packaging containing a surgical instrument, and a sensor comprising a circuit disposed on a first portion of the manufacturer-sealed sterile surgical packaging and a conductive element disposed on a second portion of the manufacturer-sealed sterile surgical packaging were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
The claim further recites the additional element of “receiving a data set characterizing at least a physical historical event experienced by the manufacturer-sealed sterile surgical package, wherein the data set characterizes a breach of the manufacturer-sealed sterile surgical package indicated by the physical break of the circuit.” MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. MPEP 2106.05(g) Insignificant Extra Solution Activity indicates that when determining whether an additional element is insignificant extra-solution activity at Step 2B the examiner may consider the following: whether the extra-solution limitation is well known, whether the limitation is significant (i.e., it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention) and whether the limitation amounts to necessary data gathering and output (i.e., all uses of the recited judicial exception require such data gathering or data output). After reevaluation of the extra-solution activity at Step 2B, the recited limitation was determined to be well understood routine and conventional activity because it amounts to receiving or transmitting data over a network, the recited limitation does not impose meaningful limits on the claim such that it is not nominally or tangentially related to the invention and the limitation amounts to necessary data gathering. MPEP 2106.05(d) Well-Understood Routine, Conventional Activity indicates that the courts have recognized receiving or transmitting data over a network as well‐understood, routine, and conventional functions when they claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. As secondary evidence, see US 20150332142 A1 (hereafter Coveley) which indicates that tamper resistant packaging is well known in the art (see para. [0003]) and that, according to another aspect there is provided a radio frequency identification seal comprising an antenna including a main antenna portion and at least one break-away portion; and an RFID tag coupled and tuned to the antenna, the RFID tag outputting a signature in response to a scanning signal when tuned to the antenna (see para. [0013]). Accordingly, even in combination, these additional elements do not provide significantly more.
Dependent Claims and Dependent Additional Elements
Claims 2-5, 8-10, and 12 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 2 and 11 merely describe(s) details concerning the stored parameters and the adjusted parameters. Claim 3 and 12 merely describes historic states include certain information experienced by the surgical packaging. Claim 4 and 13 merely describes the future states include at least one of certain types of information. Claim 5 and 14 merely describes the operational information includes certain information including operational instructions. Claim 6 and 15 merely describes providing, based on an on-demand user request, at least a portion of certain parameters. Claim 7 merely describes the on-demand user request requires an authentication to access the stored parameters. Claim 8 and 17 merely describes the graphical display comprises at least one e-ink label. Claim 9 merely describes the adjusted parameters are transmitted and displayed on a certain device. Claim 16 merely describes the on-demand user request is authenticated prior to providing the at least a portion of certain parameters.
The dependent claims also includes the additional element of “e-ink label,” and a remote device in electronic communication with the manufacturer-sealed sterile surgical packaging. The additional elements of an “e-ink label,” and a “remote device in electronic communication with the manufacturer-sealed sterile surgical packaging” generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
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) 1,2,10-11,18 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 02/095675 A1 (hereafter Hickle) in view of Intelligent Packaging and Intelligent Medicine Box for Medication Management towards the Internet of Things (hereafter Pang) in view of US 2020/0100825 A1 (hereafter Henderson) in view of Correa (Feature Aligned Volume Manipulation for Illustration and Visualization).
Regarding Claim 1
Hickle teaches:
[…]
wherein the manufacturer-sealed sterile surgical packaging comprises a sensor, wherein the sensor comprises a circuit disposed on a first portion of the manufacturer-sealed sterile surgical packaging and a conductive element disposed on a second portion of the manufacturer-sealed sterile surgical packaging and a conductive element disposed on a second portion of the manufacturer-sterile surgical packaging is sealed, and wherein the conductive element is configured to be removed from the interruption to physically break the circuit upon an opening of the manufacturer-sealed sterile surgical packaging; [Hickle teaches at pg. 4 that Fig. 4 is a perspective view of a box housing a medical kit or supply or component that is tagged with an RFID label that has a peel away cover. Hickle teaches a pg. 4 that Figure 5 is a partially exploded view of an electronically erasable programmable read only memory (EEPROM) tag showing electrical contact between an EEPROM tag embedded in a removable supply or component and an EEPROM reader/writer attached to a capital equipment unit. Hickle teaches at Claim 16 the medical supply or component according to claim 11, wherein said tag is a radio frequency identification tag and is inductively coupled to said electronic data reader. Hickle teaches at claim 69 the electronic tag according to claim 66, wherein said electronic data transmitter comprises a read/write memory such that said previously stored data can be altered and said tearable label is adapted to serve as a tamper-evident seal and electronic indicator of an item selected from the group consisting of a medical apparatus, medical equipment, storage device, resuscitation kit, medical kit, sedation and analgesia kit, sedation and analgesia resuscitation kit, drug or equipment container, and a drug or equipment package. Hickle teaches at claim 33 the medical treatment system according to claim 31, wherein said breakable conductive loop comprises conductive material applied on a breakable seal wherein said breaking of said seal to use said medical supply or component or ready said medical supply or component for use causes said conductive loop to be broken. Hickle teaches at claim 22 the medical supply or component according to claim 11, wherein said mechanical use indicator comprises a breakable conductive loop connected to said tag wherein said loop assigns said second data set a first value when intact and a second value when broken. Hickle teaches at pg. 10 item 12 teaches a breakable conductive loop will be placed around a glued edge of a kit package. Collectively, this teaches A system, comprising: a manufacturer-sealed sterile surgical packaging containing a surgical instrument configured to be used in a surgical procedure, the manufacturer-sealed sterile surgical packaging including a graphical display disposed thereon, wherein the manufacturer-sealed sterile surgical packaging including a graphical display disposed thereon, wherein the manufacturer-sealed sterile surgical packaging including a graphical display disposed thereon, wherein the manufacturer-sealed sterile surgical packaging comprises a sensor, wherein the sensor comprises a circuit disposed on a first portion of the manufacturer-sealed sterile surgical packaging and a conductive element disposed on a second portion of the manufacturer-sealed sterile surgical packaging and a conductive element disposed on a second portion of the manufacturer-sterile surgical packaging is sealed, and wherein the conductive element is configured to be removed from the interruption to physically break the circuit upon an opening of the manufacturer-sealed sterile surgical packaging.]
[…]
the memory storing instructions configured to cause the at least one data processor to perform operations comprising: storing parameters corresponding to the surgical instrument; [Hickle teaches at pg. 4 that Fig. 4 is a perspective view of a box housing a medical kit or supply or component that is tagged with an RFID label that has a peel away cover. Hickle teaches a pg. 4 that Figure 5 is a partially exploded view of an electronically erasable programmable read only memory (EEPROM) tag showing electrical contact between an EEPROM tag embedded in a removable supply or component and an EEPROM reader/writer attached to a capital equipment unit. Hickle teaches at Claim 16 the medical supply or component according to claim 11, wherein said tag is a radio frequency identification tag and is inductively coupled to said electronic data reader. Hickle teaches at claim 69 the electronic tag according to claim 66, wherein said electronic data transmitter comprises a read/write memory such that said previously stored data can be altered and said tearable label is adapted to serve as a tamper-evident seal and electronic indicator of an item selected from the group consisting of a medical apparatus, medical equipment, storage device, resuscitation kit, medical kit, sedation and analgesia kit, sedation and analgesia resuscitation kit, drug or equipment container, and a drug or equipment package. Hickle teaches at claim 33 the medical treatment system according to claim 31, wherein said breakable conductive loop comprises conductive material applied on a breakable seal wherein said breaking of said seal to use said medical supply or component or ready said medical supply or component for use causes said conductive loop to be broken. Hickle teaches at claim 22 the medical supply or component according to claim 11, wherein said mechanical use indicator comprises a breakable conductive loop connected to said tag wherein said loop assigns said second data set a first value when intact and a second value when broken. These values are interpreted as the stored surgical parameters. Hickle teaches at pg. 10 item 12 teaches a breakable conductive loop will be placed around a glued edge of a kit package.]
receiving a data set characterizing at least a physical historical event experienced by the manufacturer sealed sterile surgical packaging, wherein the data set characterizes a breach of the manufacturer-sealed sterile surgical package indicated by the physical break of the circuit; [Hickle teaches at pg. 4 that Fig. 4 is a perspective view of a box housing a medical kit or supply or component that is tagged with an RFID label that has a peel away cover. Hickle teaches a pg. 4 that Figure 5 is a partially exploded view of an electronically erasable programmable read only memory (EEPROM) tag showing electrical contact between an EEPROM tag embedded in a removable supply or component and an EEPROM reader/writer attached to a capital equipment unit. Hickle teaches at Claim 16 the medical supply or component according to claim 11, wherein said tag is a radio frequency identification tag and is inductively coupled to said electronic data reader. Hickle teaches at claim 69 the electronic tag according to claim 66, wherein said electronic data transmitter comprises a read/write memory such that said previously stored data can be altered and said tearable label is adapted to serve as a tamper-evident seal and electronic indicator of an item selected from the group consisting of a medical apparatus, medical equipment, storage device, resuscitation kit, medical kit, sedation and analgesia kit, sedation and analgesia resuscitation kit, drug or equipment container, and a drug or equipment package. Hickle teaches at claim 33 the medical treatment system according to claim 31, wherein said breakable conductive loop comprises conductive material applied on a breakable seal wherein said breaking of said seal to use said medical supply or component or ready said medical supply or component for use causes said conductive loop to be broken. Hickle teaches at claim 22 the medical supply or component according to claim 11, wherein said mechanical use indicator comprises a breakable conductive loop connected to said tag wherein said loop assigns said second data set a first value when intact and a second value when broken. The received second value when broken is interpreted as the physical historical event experienced by the manufacturer sealed sterile surgical packaging, wherein the data set characterizes a breach of the manufacturer-sealed sterile surgical package indicated by the physical break of the circuit.]
[…]
Hickle may not explicitly teach:
A system, comprising: a manufacturer-sealed sterile surgical packaging containing a surgical instrument configured to be used in a surgical procedure, the manufacturer-sealed sterile surgical packaging including a graphical display disposed thereon,
at least one data processor disposed in the surgical packaging and in operable communication with the graphical display and the sensor;
and memory disposed in the surgical packaging and in operable communication with the at least one data processor,
adjusting, based on the received data set, the stored parameters;
determining a graphical depiction characterizing the adjusted parameters and generating a control signal configured to display the graphical depiction of the adjusted parameters on the graphical display.
Pang teaches:
A system, comprising: a manufacturer-sealed sterile surgical packaging containing a surgical instrument configured to be used in a surgical procedure, the manufacturer-sealed sterile surgical packaging including a graphical display disposed thereon, [Pang teaches at Figure 2 the vision of the intelligent and interactive packaging (interpreted to be surgical packaging) that includes a display, power scavenging (no battery), micro-power wireless link, circuit, sensor interface (humidity, CO2 etc.) and a touch interface.]
at least one data processor disposed in the surgical packaging and in operable communication with the graphical display and the sensor; [Pang teaches at Figure 2 the vision of the intelligent and interactive packaging (interpreted to be surgical packaging) that includes a display, power scavenging (no battery), micro-power wireless link, circuit, sensor interface (humidity, CO2 etc.) and a touch interface.]
and memory disposed in the surgical packaging and in operable communication with the at least one data processor, [Pang teaches at Figure 2 the vision of the intelligent and interactive packaging (interpreted to be surgical packaging) that includes a display, power scavenging (no battery), micro-power wireless link, circuit, sensor interface (humidity, CO2 etc.) and a touch interface.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang with the motivation of addressing medication noncompliance, which is a problem has caused serious threat to public health as well as huge financial waste world wide (Pang at the Abstract).
Hickle/Pang may not explicitly teach:
adjusting, based on the received data set, the stored parameters;
determining a graphical depiction characterizing the adjusted parameters and generating a control signal configured to display the graphical depiction of the adjusted parameters on the graphical display.
Henderson teaches:
adjusting, based on the received data set, the stored parameters; [Henderson teaches at the Abstract the energy the method includes causing the energy module to provide the output driving the energy modality delivered by the surgical instruments; sensing a parameter associated with the secondary module; receiving the parameter as sensed by the secondary module at the energy module; and adjusting the output from the energy module from a first state to a second state according to the received parameter.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang to the method for communicating between modules and devices in a modular system of Henderson with the motivation of addressing the needs related to the fact that operating rooms (ORs) are in need of streamlined capital solutions because ORs are a tangled web of cords, devices, and people due to the number of different devices that are needed to complete each surgical procedure (Henderson at para. [0006]).
Hickle/Pang/Henderson may not explicitly teach:
determining a graphical depiction characterizing the adjusted parameters and generating a control signal configured to display the graphical depiction of the adjusted parameters on the graphical display.
Correa teaches:
determining a graphical depiction characterizing the adjusted parameters and generating a control signal configured to display the graphical depiction of the adjusted parameters on the graphical display. [Correa teaches at pg. 1071 different parameters of the peeler, such as thickness of the cut and the angle of bending of the peeled layer, will be manipulated interactively to obtain different illustrative effects. Correa teaches at pg. 1071 for example, the different virtual flaps in Figure 1(c) are obtained by placing multiple peeler operators around the body and varying their parameters. The control signal resulting in the interactive manipulative to obtain different illustrative effects is interpreted as the control signal configured to display the graphical depiction of the adjusted parameters on the graphical display.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang to the method for communicating between modules and devices in a modular system of Henderson to the feature volume manipulation for illustration and visualization of Correa with the motivation of addressing the need for a real-time solution that supports the specification and visualization of illustrative manipulation (Correa at the Abstract).
Regarding Claims 10 and 18
Due to their similarity to Claim 1, Claims 10 and 18 are similarly analyzed and rejected in a manner consistent with the rejection of Claim 1.
Regarding Claim 2
Hickle/Pang/Henderson/Correa teach the system of claim 1. Hickle/Pang/Henderson/Correa further teach:
wherein the stored parameters and adjusted parameters include information characterizing at least one of historic states, future states or operational information. [Hickle teaches at claim 22 the medical supply or component according to claim 11, wherein said mechanical use indicator comprises a breakable conductive loop connected to said tag wherein said loop assigns said second data set a first value when intact and a second value when broken. The value intact is interpreted as the parameters include information characterizing at least one of historic state, the value when broken is interpreted as the information characterizing one of future states or operational information.]
Regarding Claim 11
Due to its similarity to Claim 2, Claims 11 is similarly analyzed and rejected in a manner consistent with the rejection of Claim 2.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 02/095675 A1 (hereafter Hickle) in view of Intelligent Packaging and Intelligent Medicine Box for Medication Management towards the Internet of Things (hereafter Pang) in view of US 2020/0100825 A1 (hereafter Henderson) in view of Correa (Feature Aligned Volume Manipulation for Illustration and Visualization) in view of JP 6542317 B2 (hereafter Humayun).
Regarding Claim 9
Hickle/Pang/Henderson/Correa teach the system of claim 1. Hickle/Pang/Henderson/Correa may not explicitly teach:
wherein the adjusted parameters are transmitted and displayed on a remote device in electronic communication with the manufacturer-sealed sterile surgical packaging
Humayun teaches:
wherein the adjusted parameters are transmitted and displayed on a remote device in electronic communication with the manufacturer-sealed sterile surgical packaging. [Humayun teaches at pg. 21 that the rack system comprises a processor configured to process user input received at the sterile surgical tray. Humayun teaches at pg. 7 although it is contemplated that the suitable sterile tray will be packaged and sterilized with the pump container, pump and motor, the pump container, the pump and motor may be packaged without sterilization. The sterile surgical tray is interpreted as sealed sterile surgical packaging, the definition of package being a commodity or a unit of a product uniformly wrapped and sealed. Humayun teaches at pg. 21 the surgical tray system according to claim 3, wherein the handpiece is in communication with the rack system via the sterile surgical tray. Humayun teaches at pg. 21 a display in the sterile surgical tray in communication with the rack system. Humayun teaches at pg. 18 user input entered into the controller on the surgical device or entered by the controller on the surgical device will be transmitted to the rack system directly or via the surgical tray (via wired or wireless connection). Humayun teaches at pg. 4 the surgical console also typically includes a large display screen for displaying and entering a plurality of parameters that control device used during surgery. Collectively, Humayun teaches: wherein the adjusted parameters are transmitted and displayed on a remote device in electronic communication with the manufacturer-sealed sterile surgical packaging.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang to the method for communicating between modules and devices in a modular system of Henderson to the feature volume manipulation for illustration and visualization of Correa to the sterile surgery tray of Humayun with the motivation of addressing the need for surgical systems and products that allow surgeons to perform safe, efficient, cost-effective surgery with little or no assistance during surgery (Humayun at pg. 2).
Claim(s) 3-7,12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 02/095675 A1 (hereafter Hickle) in view of Intelligent Packaging and Intelligent Medicine Box for Medication Management towards the Internet of Things (hereafter Pang) in view of Correa (Feature Aligned Volume Manipulation for Illustration and Visualization) in view of US 2020/0100825 A1 (hereafter Henderson) in view of US 11968205 B1 (hereafter Mousseau).
Regarding Claim 3
Hickle/Pang/Henderson/Correa teach the system of claim 2. Hickle/Pang/Henderson/Correa may not explicitly teach:
wherein the historic states include at least one of manufacturing information, materials and components information, geographical origin information, or environmental information experienced by the surgical packaging.
Mousseau teaches:
wherein the historic states include at least one of manufacturing information, materials and components information, geographical origin information, or environmental information experienced by the surgical packaging. [Mousseau teaches at col. 9 line 53-55 teaches in some embodiments, the electronic asset is specifically selected for its manufacturing origins, and communication and tracking is performed directly with the electronic asset. Mousseau teaches at Figure 3 Item 324 displaying a saved serial number. This is interpreted as wherein the historic states include at least one of manufacturing information. ]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang to the method for communicating between modules and devices in a modular system of Henderson to the feature volume manipulation for illustration and visualization of Correa to the systems, devices, and methods for securely communicating with electronic assets using an authenticated computer hub and a central server of Mousseau to with the motivation of addressing the need to rectify systems that lack of control over what electronic assets are being used and the quality of each electronic asset (Mousseau at col. 1 line 50-52).
Regarding Claim 4
Hickle/Pang/Henderson/Correa teach the system of claim 2. Hickle/Pang/Henderson/Correa may not explicitly teach:
wherein the future states include at least one of an intended destination information, environmental requirements information, customs information, disposal information, or error reporting procedures information.
Mousseau teaches:
wherein the future states include at least one of an intended destination information, environmental requirements information, customs information, disposal information, or error reporting procedures information. [Mousseau teaches at Figure 3 Item 312 hub location. This is interpreted to be wherein the future states include at least one of destination information.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang to the method for communicating between modules and devices in a modular system of Henderson to the feature volume manipulation for illustration and visualization of Correa to the systems, devices, and methods for securely communicating with electronic assets using an authenticated computer hub and a central server of Mousseau to with the motivation of addressing the need to rectify systems that lack of control over what electronic assets are being used and the quality of each electronic asset (Mousseau at col. 1 line 50-52).
Regarding Claim 5
Hickle/Pang/Henderson/Correa teach the system of claim 2. Hickle/Pang/Henderson/Correa may not explicitly teach:
wherein the operational information includes at least one of product compatibility information, expected lifecycle information, or operational instructions.
Mousseau teaches:
wherein the operational information includes at least one of product compatibility information, expected lifecycle information, or operational instructions. [Mousseau teaches at Figure 3 Item 316 operational information includes Item 318 an administration schedule. This is interpreted to be operational instructions.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang to the method for communicating between modules and devices in a modular system of Henderson to the feature volume manipulation for illustration and visualization of Correa to the systems, devices, and methods for securely communicating with electronic assets using an authenticated computer hub and a central server of Mousseau to with the motivation of addressing the need to rectify systems that lack of control over what electronic assets are being used and the quality of each electronic asset (Mousseau at col. 1 line 50-52).
Regarding Claim 6
Hickle/Pang/Henderson/Correa teach the system of claim 1. Hickle/Pang/Henderson/Correa may not explicitly teach:
wherein the operations further comprise providing, based on an on-demand user request, at least a portion of the stored parameters.
Mousseau teaches:
wherein the operations further comprise providing, based on an on-demand user request, at least a portion of the stored parameters. [Mousseau teaches at col. 10 line 63 – col. 11, line 2 that the authenticated computer hub 116 has a communication device for transmitting a hub identity uniquely identifying the computer hub and communication results received from one or more authenticated electronic assets to a central server, and for receiving electronic asset identities to be authorized with control directive definition operational usage parameters. Mousseau teaches at col. 11 line 3-5 teaches that the authenticated computer hub has a user interface to display the electronic assets 120 have been granted access and to connect to authorized electronic assets 120. Mousseau teaches at Figure 3 Item 314 a user interface with indication that a device is authenticated that shows at 334 and 332 what are interpreted to be operational parameters. Mousseau teaches at Figure 3, bottom, the option to save to device. The option to save to the device is interpreted as the on-demand user request. Collectively, the teachings of Mousseau are interpreted to be wherein the operations further comprise providing, based on an on-demand user request, at least a portion of the stored parameters.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang to the method for communicating between modules and devices in a modular system of Henderson to the feature volume manipulation for illustration and visualization of Correa to the systems, devices, and methods for securely communicating with electronic assets using an authenticated computer hub and a central server of Mousseau to with the motivation of addressing the need to rectify systems that lack of control over what electronic assets are being used and the quality of each electronic asset (Mousseau at col. 1 line 50-52).
Regarding Claim 7
Hickle/Pang/Henderson/Correa/Mousseau teach the system of claim 6. Hickle/Pang/Henderson/Correa/Mousseau further teach:
wherein the on-demand user request requires an authentication to access the stored parameters. [Mousseau teaches at col. 10 line 63 – col. 11, line 2 that the authenticated computer hub 116 has a communication device for transmitting a hub identity uniquely identifying the computer hub and communication results received from one or more authenticated electronic assets to a central server, and for receiving electronic asset identities to be authorized with control directive definition operational usage parameters. Mousseau teaches at col. 11 line 3-5 teaches that the authenticated computer hub has a user interface to display the electronic assets 120 have been granted access and to connect to authorized electronic assets 120. Mousseau teaches at Figure 3 Item 314 a user interface with indication that a device is authenticated that shows at 334 and 332 what are interpreted to be operational parameters. Mousseau teaches at Figure 3, bottom, the option to save to device. The option to save to the device is interpreted as the on-demand user request. Collectively, the teaching of Mousseau are interpreted to be wherein the on-demand user request requires an authentication to access the stored parameters.]
Regarding Claim 12
Hickle/Pang/Henderson/Correa teach the method of claim 11. Hickle/Pang/Henderson/Correa may not explicitly teach:
wherein the historic states include at least one of manufacturing information, materials and components information, geographical origin information or environmental information experienced by the surgical packaging.
Mousseau teaches:
wherein the historic states include at least one of manufacturing information, materials and components information, geographical origin information or environmental information experienced by the surgical packaging. [Mousseau teaches at col. 9 line 53-55 teaches in some embodiments, the electronic asset is specifically selected for its manufacturing origins, and communication and tracking is performed directly with the electronic asset. Mousseau teaches at Figure 3 Item 324 displaying a saved serial number. This is interpreted as wherein the historic states include at least one of manufacturing information. ]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang to the method for communicating between modules and devices in a modular system of Henderson to the feature volume manipulation for illustration and visualization of Correa to the systems, devices, and methods for securely communicating with electronic assets using an authenticated computer hub and a central server of Mousseau to with the motivation of addressing the need to rectify systems that lack of control over what electronic assets are being used and the quality of each electronic asset (Mousseau at col. 1 line 50-52).
Regarding Claim 13
Hickle/Pang/Henderson/Correa teach the method of claim 11. Hickle/Pang/Henderson/Correa may not explicitly teach:
wherein the future states include at least one of an intended destination information, environmental requirements information, customs information, disposal information, or error reporting procedures information.
Mousseau teaches:
wherein the future states include at least one of an intended destination information, environmental requirements information, customs information, disposal information, or error reporting procedures information. [Mousseau teaches at Figure 3 Item 312 hub location. This is interpreted to be wherein the future states include at least one of destination information.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang to the method for communicating between modules and devices in a modular system of Henderson to the feature volume manipulation for illustration and visualization of Correa to the systems, devices, and methods for securely communicating with electronic assets using an authenticated computer hub and a central server of Mousseau to with the motivation of addressing the need to rectify systems that lack of control over what electronic assets are being used and the quality of each electronic asset (Mousseau at col. 1 line 50-52).
Regarding Claim 14
Hickle/Pang/Henderson/Correa teach the method of claim 11. Hickle/Pang/Henderson/Correa may not explicitly teach:
wherein the operational information includes at least one of product compatibility information, expected lifecycle information or operational instructions.
Mousseau teaches:
wherein the operational information includes at least one of product compatibility information, expected lifecycle information or operational instructions. [Mousseau teaches at Figure 3 Item 316 operational information includes Item 318 an administration schedule. This is interpreted to be operational instructions.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang to the method for communicating between modules and devices in a modular system of Henderson to the feature volume manipulation for illustration and visualization of Correa to the systems, devices, and methods for securely communicating with electronic assets using an authenticated computer hub and a central server of Mousseau to with the motivation of addressing the need to rectify systems that lack of control over what electronic assets are being used and the quality of each electronic asset (Mousseau at col. 1 line 50-52).
Regarding Claim 15
Hickle/Pang/Henderson/Correa teach the method of claim 10. Hickle/Pang/Henderson/Correa may not explicitly teach:
further comprising providing, based on an on-demand user request, at least a portion of the stored parameters.
Mousseau teaches:
further comprising providing, based on an on-demand user request, at least a portion of the stored parameters. [Mousseau teaches at col. 10 line 63 – col. 11, line 2 that the authenticated computer hub 116 has a communication device for transmitting a hub identity uniquely identifying the computer hub and communication results received from one or more authenticated electronic assets to a central server, and for receiving electronic asset identities to be authorized with control directive definition operational usage parameters. Mousseau teaches at col. 11 line 3-5 teaches that the authenticated computer hub has a user interface to display the electronic assets 120 have been granted access and to connect to authorized electronic assets 120. Mousseau teaches at Figure 3 Item 314 a user interface with indication that a device is authenticated that shows at 334 and 332 what are interpreted to be operational parameters. Mousseau teaches at Figure 3, bottom, the option to save to device. The option to save to the device is interpreted as the on-demand user request. Collectively, the teaching of Mousseau is interpreted to be wherein the on-demand user request is authenticated prior to providing the at least a portion of the stored parameters.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang to the method for communicating between modules and devices in a modular system of Henderson to the feature volume manipulation for illustration and visualization of Correa to the systems, devices, and methods for securely communicating with electronic assets using an authenticated computer hub and a central server of Mousseau to with the motivation of addressing the need to rectify systems that lack of control over what electronic assets are being used and the quality of each electronic asset (Mousseau at col. 1 line 50-52).
Regarding Claim 16
Hickle/Pang/Henderson/Correa/Mousseau teach the method of claim 15. Hickle/Pang/Henderson/Correa/Mousseau further teach:
wherein the on-demand user request is authenticated prior to providing the at least a portion of the stored parameters. [Mousseau teaches at col. 10 line 63 – col. 11, line 2 that the authenticated computer hub 116 has a communication device for transmitting a hub identity uniquely identifying the computer hub and communication results received from one or more authenticated electronic assets to a central server, and for receiving electronic asset identities to be authorized with control directive definition operational usage parameters. Mousseau teaches at col. 11 line 3-5 teaches that the authenticated computer hub has a user interface to display the electronic assets 120 have been granted access and to connect to authorized electronic assets 120. Mousseau teaches at Figure 3 Item 314 a user interface with indication that a device is authenticated that shows at 334 and 332 what are interpreted to be operational parameters. Mousseau teaches at Figure 3, bottom, the option to save to device. The option to save to the device is interpreted as the on-demand user request. Collectively, the teaching of Mousseau is interpreted to be wherein the on-demand user request is authenticated prior to providing the at least a portion of the stored parameters.]
Claim(s) 8 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 02/095675 A1 (hereafter Hickle) in view of Intelligent Packaging and Intelligent Medicine Box for Medication Management towards the Internet of Things (hereafter Pang) in view of US 2020/0100825 A1 (hereafter Henderson) in view of Correa (Feature Aligned Volume Manipulation for Illustration and Visualization) in view of Jambaulikar (Electronic Paper Displays in Hospital Operations: Deployment and Implementation).
Regarding Claim 8
Hickle/Pang/Henderson/Correa teach the system of claim 1. Hickle/Pang/Henderson/Correa may not explicitly teach:
wherein the graphical display comprises at least one e-ink label.
Jambaulikar teaches:
wherein the graphical display comprises at least one e-ink label. [Jambaulikar teaches at Figure 1 a working principle of electronic ink displays. This teaches where the graphical display comprises at least one e-ink label (the display is interpreted as an label).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare at the time of filing, to modify the RF-ID label for a medical container of Hickle to the intelligent packaging and intelligent medicine box for medication management towards the Internet of Thing of Pang to the method for communicating between modules and devices in a modular system of Henderson to the feature volume manipulation for illustration and visualization of Correa to the electronic paper displays in hospital operations: proposal for deployment and implementation of Jambaulikar with the motivation to improve the electronic paper displays in hospital operations: proposal for deployment and implementation with the motivation of adopting techniques that clinicians demonstrated, such as whiteboards, which increase patient engagement, thereby increasing satisfaction, mitigating common medical errors, and enhancing continuity of care (Jambaulikar at pg. 2, the Introduction).
Regarding Claim 17
Due to its similarity to Claim 8, Claim 17 is similarly analyzed and rejected in a manner consistent with the rejection of Claim 8.
Response to Arguments
35 U.S.C. 103 Argument Responses
Applicant argues that Pederson does not teach “wherein the manufacturer-sealed sterile surgical packaging comprises a sensor, wherein the sensor comprises a circuit disposed on a first portion of the manufacturer-sealed sterile surgical packaging and a conductive element disposed on a second portion of the manufacturer-sealed sterile surgical packaging, wherein the circuit comprises an interruption, and wherein the conductive element bridges the interruption to complete the circuit while the manufacturer-sealed sterile surgical packaging is sealed, and wherein the conductive element is configured to be removed from the interruption to physical break the circuit upon an opening of the manufacturer-sealed sterile surgical packaging,” or “the data set characterizes a breach of the manufacturer-sealed sterile surgical package indicated by the physical break of the circuit,” as recited in amended claims 1,10, and 18. Applicant submits that Henderson, Humayun, and Correa do not cure the deficiencies of Pederson.
The 35 U.S.C. 103 rejection has been updated in response to the amendment and the argument is moot. New art replaces Pedersen.
35 U.S.C. 101 Argument Responses
Under Step 2A Prong Two, a claim is not considered as being directed toward an abstract idea the claim as a whole integrates the judicial exception into a practical application. See MPEP 2106.04(d). See also USPTO August 4, 2025 Memorandum, Reminders on evaluating subject matter eligibility of claims under 35 USC 101. Under 2025 Memorandum, the evaluation under Step 2A, Prong Two requires analyzing the claim as a whole, taking into consideration all claim limitations and how these limitations interact and impact each other when evaluating whether the exception is integrated into a practical application.
The claim was considered as a whole. To paraphrase, the claim requires storing parameters corresponding to the surgical instrument, receiving an interruption signal from a conductive element in communication with sterile surgical packaging, adjusting the stored parameters based on the received data, and then determining a graphical depiction and generating a control signal to display the graphical depiction of the adjusted parameters in the manner specifically recited in the abstract idea.
The 35 U.S.C. 101 rejection will not be reiterated in its entirety here in the absence of specific arguments. Please see that rejection. The additional elements invoked a variety of analysis that is explained in detail in that rejection. However, to summarize and respond at the same level of scope as presented in the argument, one fundamental reason that the abstract idea and judicial exception, for the reasons outlined in that rejection, were not integrated into a practical application of the exception was that the abstract idea was not meaningfully limited by the numerous additional elements. The Examiner cannot anticipate a response of course, but one avenue of forward momentum in prosecution might be gained by integrating the particular machine into the steps of the abstract idea so that the machine is not merely performing data gathering, which in this case was nominal or tangential to the claim. Additionally, the search for an improvement is often referred to as the search for a technical solution to a technical problem. Examiner has reviewed the specification. While the claim itself does not necessarily need to recite the technical problem, it should reflect the desired features/steps etc. of the invention resulting in the claimed technical solution/improvement. The Examiner notes that this is broadly reflected by the contents of the memorandum cited by Applicant in the question stem below. Currently, there is no improvement at Step 2A prong two because the additional elements do not integrate the judicial exception into a practical application because they are not meaningfully limiting the abstract idea. The additional elements have a tangential or nominal relationship to the abstract idea (the machine described is engaged in mere data gathering to inform and enable operation of the abstract idea), and the abstract idea itself is actually facilitated by mere generic computer part(s).
The memorandum further explain that one way to show integration is if the claims reflect an improvement to the functioning of a computer or to another technology or technical field. The memorandum clarifies the standard for this evaluation: “The examiner is reminded to consult the specification to determine whether the disclosed invention improves technology or a technical field, and evaluate the claim to ensure it reflects the disclosed improvement”. The memorandum further notes that the claim itself does not need to explicitly recite the improvement described in the specification.
MPEP 2106.04(d)(1) Evaluating Improvements in the Functioning of a Computer, or an Improvement to Any Other Technology or Technical Field in Step 2A Prong Two indicates a claim reciting a judicial exception is not directed to the judicial exception if it also recites additional elements demonstrating that the claim as a whole integrates the exception into a practical application and that one way to demonstrate such integration is when the claimed invention improves the functioning of a computer or improves another technology or technical field. MPEP 2106.04(d) Integration of a Judicial Exception Into a Practical Application teaches that limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
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, as discussed in MPEP § 2106.05(e).
To summarize, there is no improvement in the functioning of a computer, or an improvement to other technology or technical field recited, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a) and as touched upon in the response above.
The Examiner thanks the Applicant for the summary of the memorandum, which reinforces and supports the material presented in the MPEP. The Examiner agrees with the assertion that the specification should be consulted to determine the technical solution to a technical problem (improvements inquiry) to determine whether the additional elements integrate the judicial exception into a practical application of the exception at step 2A and step 2B of the Alice/Mayo subject matter eligibility analysis. The Examiner disagrees with Applicant’s characterization of the memorandum and suggests that the memorandum reinforces the MPEP, which indicates generally that the features or steps of the invention that result in the technical solution to the technical problem must be present in the claims. Currently, there is no improvement at Step 2A prong two because the additional elements do not integrate the judicial exception into a practical application because they are not meaningfully limiting the abstract idea. The additional elements have a tangential or nominal relationship to the abstract idea (the machine described is engaged in mere data gathering to inform and enable operation of the abstract idea), and the abstract idea itself is actually facilitated by mere generic computer part(s). For example, MPEP 2106.05(g) Insignificant Extra Solution Activity indicates that when determining whether an additional element is insignificant extra-solution activity at Step 2B the examiner may consider the following: whether the extra-solution limitation is well known, whether the limitation is significant (i.e., it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention) and whether the limitation amounts to necessary data gathering and output (i.e., all uses of the recited judicial exception require such data gathering or data output).
The claim further recites the additional element of “receiving a data set characterizing at least a physical historical event experienced by the manufacturer-sealed sterile surgical package, wherein the data set characterizes a breach of the manufacturer-sealed sterile surgical package indicated by the physical break of the circuit.” MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. MPEP 2106.05(g) Insignificant Extra Solution Activity indicates that when determining whether an additional element is insignificant extra-solution activity at Step 2B the examiner may consider the following: whether the extra-solution limitation is well known, whether the limitation is significant (i.e., it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention) and whether the limitation amounts to necessary data gathering and output (i.e., all uses of the recited judicial exception require such data gathering or data output). After reevaluation of the extra-solution activity at Step 2B, the recited limitation was determined to be well understood routine and conventional activity because it amounts to receiving or transmitting data over a network, the recited limitation does not impose meaningful limits on the claim such that it is not nominally or tangentially related to the invention and the limitation amounts to necessary data gathering and output. MPEP 2106.05(d) Well-Understood Routine, Conventional Activity indicates that the courts have recognized receiving or transmitting data over a network as well‐understood, routine, and conventional functions when they claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. As secondary evidence, see US 20150332142 A1 (hereafter Coveley) which indicates that tamper resistant packaging is well known in the art (see para. [0003]) and that, according to another aspect there is provided a radio frequency identification seal comprising an antenna including a main antenna portion and at least one break-away portion; and an RFID tag coupled and tuned to the antenna, the RFID tag outputting a signature in response to a scanning signal when tuned to the antenna (see para. [0013]). Accordingly, even in combination, these additional elements do not provide significantly more.
To summarize, after reevaluation of the extra-solution activity at Step 2B, the recited limitation “receiving a data set characterizing at least a physical historical event experienced by the manufacturer-sealed sterile surgical package, wherein the data set characterizes a breach of the manufacturer-sealed sterile surgical package indicated by the physical break of the circuit” was determined to be well understood routine and conventional activity, and the recited limitation does not impose meaningful limits on the claim such that it is not nominally or tangentially related to the invention and the limitation amounts to necessary data gathering and output. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application or provide significantly more.
Applicant asserts that the amendment to claims 1,10 and 18 is an improvement to the technical fields of smart packaging hardware and sterility assurance that is set forth in the specification.
This assertion is redundant and has been dealt with in the response above.
The specification explains that the system is designed to “prevent the reuse of data stored in the packaging” by determining that the sensor is “destroyed when the packaging is opened” (Specification, para. [0039]). The specification explains that a “lid contains a conductive filament that interconnects” an interruption in a circuit, such that the “act of peeling will remove the jumper and interrupt the circuit” (Specification, para. [0139]). The specification explains that the hardware may affect the ability to use “digital solutions information” if the device integrity is compromised (Specification, para. [0139]). Thus, the specification sets forth an improvement in technology that is also reflected in amended claims 1,10, and 18. Consequently, amended claims 1,10 and 18 integrate the judicial exception into a practical application, such that amended claims 1,10, and 18 are not directed to an abstract idea. Therefore, amended claims 1,10, and 18 and their dependent claims are patent eligible under Step 2A Prong Two.
The claim further actually recites the additional element of “receiving a data set characterizing at least a physical historical event experienced by the manufacturer-sealed sterile surgical package, wherein the data set characterizes a breach of the manufacturer-sealed sterile surgical package indicated by the physical break of the circuit.” The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. MPEP 2106.05(g) Insignificant Extra Solution Activity indicates that when determining whether an additional element is insignificant extra-solution activity at Step 2A Prong Two, the examiner may consider the following: whether the limitation is significant (i.e., does it impose meaningful limits on the claim such that it is not nominally or tangentially related to the invention) and whether the limitation amounts to necessary data gathering and output (i.e., all uses of the recited judicial exception require such data gathering or data output). For example, the claim limitation is nominally or tangentially related to the invention and the data gathering step does not provide meaningful limits on the claim because all uses of the recited judicial exception (the abstract idea) do not require such data gathering and output. Accordingly, even in combination, these additional elements do not integrate the abstract idea nor do they provide significantly more.
MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. MPEP 2106.05(g) Insignificant Extra Solution Activity indicates that when determining whether an additional element is insignificant extra-solution activity at Step 2B the examiner may consider the following: whether the extra-solution limitation is well known, whether the limitation is significant (i.e., it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention) and whether the limitation amounts to necessary data gathering and output (i.e., all uses of the recited judicial exception require such data gathering or data output). After reevaluation of the extra-solution activity at Step 2B, the recited limitation was determined to be well understood routine and conventional activity because it amounts to receiving or transmitting data over a network, the recited limitation does not impose meaningful limits on the claim such that it is not nominally or tangentially related to the invention and the limitation amounts to necessary data gathering and output. MPEP 2106.05(d) Well-Understood Routine, Conventional Activity indicates that the courts have recognized receiving or transmitting data over a network as well‐understood, routine, and conventional functions when they claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. As secondary evidence, see US 20150332142 A1 (hereafter Coveley) which indicates that tamper resistant packaging is well known in the art (see para. [0003]) and that, according to another aspect there is provided a radio frequency identification seal comprising an antenna including a main antenna portion and at least one break-away portion; and an RFID tag coupled and tuned to the antenna, the RFID tag outputting a signature in response to a scanning signal when tuned to the antenna (see para. [0013]). Accordingly, even in combination, these additional elements do not provide significantly more.
MPEP 2106.03 Eligibility Step 1: The Four Categories of Statutory Subject Matter indicates that a machine is a “concrete thing, consisting of parts, or of certain device and combinations of devices,” and that this category “includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result. The examiner maintains that the combination of the sensor, graphical display, and circuit (that is interrupted) in the sterile surgical packaging in conjunction with a data processor, memory, and display are recited such that they comprise a particular machine. MPEP 2106.05(b) Particular Machine indicates that when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or whether a claim recites significantly more than a judicial exception in Step 2B, examiners should consider whether the judicial exception is applied with, or by use of, a particular machine. Moreover, this same section indicates when determining whether a machine recited in a claim integrates the judicial exception into a practical application of the exception at Step 2A prong two, the following factors are relevant:
The particularity or generality of the elements of the machine or apparatus
Whether the machine or apparatus implements the steps of the method
When determining whether a machine recited in a claim provides significantly more at Step 2B, the following factors are relevant:
The particularity or generality of the elements of the machine or apparatus
Whether the machine or apparatus implements the steps of the method
Whether its involvement is extra-solution activity or a field of use
At Step 2A, the elements of the machine or apparatus were described with a degree of generality (the abstract idea is entirely facilitated via generic computer part(s)) and the machine or apparatus does not implement the steps of the method.
At Step 2B, the same considerations applied plus the involvement of the particular machine was determined to be extra-solution activity or field of use. The claim limitation is nominally or tangentially related to the invention and the data gathering step does not provide meaningful limits on the claim because all uses of the recited judicial exception (the abstract idea) do not require such data gathering and output. Accordingly, even in combination, these additional elements do not provide significantly more.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20080266057 A1 (hereafter Erickson) teaches the use of RFIID tag for enhanced lifecycle management is tangentially relevant to the subject of monitoring surgical packaging.
L. Boettcher, D. Manessis, A. Ostmann, S. Karaszkiewicz and H. Reichl, "Embedding of Chips for System in Package realization - Technology and Applications," 2008 3rd International Microsystems, Packaging, Assembly & Circuits Technology Conference, Taipei, Taiwan, 2008, pp. 383-386, doi: 10.1109/IMPACT.2008.4783892. This NPL teaches chips embedded in packaging which is clearly relevant to the subject matter herein.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRISTAN ISAAC EVANS whose telephone number is (571)270-5972. The examiner can normally be reached Mon-Thurs 8:00am-12:00pm & 1:00pm-7:00pm, off Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.I.E./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683