DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in reply to the application filed on 12/14/2024.
Claims 1-21 have been canceled.
Claims 22-58 are currently pending and have been examined.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 2/2/2025, 5/3/2025, and 12/5/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 22-58 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to an abstract idea without significantly more. Claims 22-58 are directed to a system, method, or product which are one of the statutory categories of invention. (Step 1: YES).
Independent Claim 22 discloses a predictive maintenance system comprising: one or more injection systems including an injector configured to provide one or more fluids from one or more fluid sources; a computer system comprising one or more processors programmed or configured to: receive operation data associated with the one or more injection systems, wherein the operation data includes one or more operation parameters associated with one or more operations of the one or more injection systems; determine one or more prediction scores for the one or more injection systems based on the operation data, wherein the one or more prediction scores include one or more predictions of one or more operation failures or misuses for the one or more injection systems; and provide maintenance data associated with the one or more operation failures or misuses, wherein the maintenance data is determined based on the one or more prediction scores.
Independent Claim 40 discloses a computer program product for predictive maintenance, the computer program product comprising at least one non-transitory computer-readable medium including program instructions that, when executed by at least one processor, cause the at least one processor to: receive operation data associated with one or more injection systems, wherein the operation data includes one or more operation parameters associated with one or more operations of the one or more injection systems; determine one or more prediction scores for the one or more injection systems based on the operation data, wherein the one or more prediction scores include one or more predictions of one or more operation failures or misuses for the one or more injection systems; and provide maintenance data associated with the one or more operation failures or misuses, wherein the maintenance data is determined based on the one or more prediction scores.
Independent Claim 41 discloses an injection system, comprising: an injector configured to provide one or more fluids from one or more fluid sources in one or more operations; one or more sensors configured to measure one or more operation parameters associated with the one or more operations of the injector; a computer system comprising one or more processors programmed or configured to: receive operation data associated with the injector, wherein the operation data includes the one or more operation parameters associated with the one or more operations of the injector; determine one or more prediction scores for the injector based on the operation data, wherein the one or more prediction scores include one or more predictions of one or more operation failures or misuses for the injector; and provide maintenance data associated with the one or more operation failures or misuses, wherein the maintenance data is determined based on the one or more prediction scores.
The examiner is interpreting the above bolded limitations as additional elements as further discussed below. The remaining un-bolded limitations are merely directed to rules or instructions to follow to identify prediction scores based on operation data and to identify maintenance data to implement based on the prediction scores. The series of steps recited above describe managing personal behavior or relationships or interactions between people and thus are grouped as certain methods of organizing human activity which is an abstract idea.
Further, the remaining un-bolded limitations are also directed to the mental process of determining prediction scores and providing maintenance data associated with one or more operation failures or misuses wherein the maintenance data is based on the prediction scores (thus, under the broadest reasonable interpretation, the claims are directed to observations and evaluations a user would make using a pen or paper). The abstract ideas are considered together as a single abstract idea for further analysis. (Step 2A- Prong 1: YES. The claims are abstract).
This judicial exception is not integrated into a practical application. Limitations that are not indicative of integration into a practical application include: (1) Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (MPEP 2106.05.f), (2) Adding insignificant extra- solution activity to the judicial exception (MPEP 2106.05.g), (3) Generally linking the use of the judicial exception to a particular technological environment or field of use (MPEP 2106.05.h).
Independent Claim 22 discloses the following additional elements:
one or more injection systems including an injector configured to provide one or more fluids from one or more fluid sources
a computer system comprising one or more processors
receive operation data associated with the one or more injection systems, wherein the operation data includes one or more operation parameters associated with one or more operations of the one or more injection systems
Independent Claim 40 discloses the following additional elements:
a computer program product for predictive maintenance, the computer program product comprising at least one non-transitory computer-readable medium including program instructions that, when executed by at least one processor, cause the at least one processor to [perform the method]
receive operation data associated with the one or more injection systems, wherein the operation data includes one or more operation parameters associated with one or more operations of the one or more injection systems;
Independent Claim 41 discloses the following additional elements:
an injector configured to provide one or more fluids from one or more fluid sources in one or more operations
one or more sensors configured to measure one or more operation parameters associated with the one or more operations of the injector
a computer system comprising one or more processors
receive operation data associated with the injector, wherein the operation data includes the one or more operation parameters associated with the one or more operations of the injector
In particular, the computer system comprising one or more processors (of claims 22 and 41) and the computer program product comprising at least one non-transitory computer-readable medium including program instructions that, when executed by at least one processor, cause the at least one processor to [perform the method] (of claim 40) are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception.
Applicant’s specification at para 53 discloses - For example, maintenance prediction system 102 can include a computing device, such as one or more computers, portable computers (e.g., tablet computers), mobile devices (e.g., cellular phones, smartphones, wearable devices, such as watches, glasses, lenses, and/or clothing, PDAs, and/or the like), a server (e.g., a transaction processing server), a group of servers, and/or other like devices.
Thus, the computing device can be various devices thus indicating that is not a specialized machine implementing the method and instead can be any generic device such as a computer, portable computer, mobile device, server, group of servers, and/or other like devices. The computing device is performing as expected and is not improved in anyway.
The one or more injections systems including an injector configured to provide one or more fluids from one or more fluid sources (of claim 22), injector configured to provide one or more fluids from one or more fluid sources in one or more operations (of claim 41) and the one or more sensors configured to measure one or more operation parameters associated with the one or more operations of the injector (of claim 41) merely generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(1) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application.
Additionally, receiving operation data associated with the one or more injection systems, wherein the operation data includes one or more operation parameters associated with one or more operations of the one or more injection systems [injector] amounts to insignificant extra-solution activity. These additional elements, even in combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
These additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Accordingly, claim(s) 22 and 40-41 are directed to an abstract idea(s) without a practical application. (Step 2A-Prong 2: NO: the additional claimed elements are not integrated into a practical application).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. 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 the computer system comprising one or more processors (of claims 22 and 41) and the computer program product comprising at least one non-transitory computer-readable medium including program instructions that, when executed by at least one processor, cause the at least one processor to [perform the method] (of claim 40) 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’). MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more").
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the one or more injections systems including an injector configured to provide one or more fluids from one or more fluid sources (of claim 22), injector configured to provide one or more fluids from one or more fluid sources in one or more operations (of claim 41) and the one or more sensors configured to measure one or more operation parameters associated with the one or more operations of the injector (of claim 41) were considered 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 been found insufficient to provide significantly more. MPEP2106.05 (A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide an inventive concept (‘significantly more").
Further, receiving operation data associated with the one or more injection systems, wherein the operation data includes one or more operation parameters associated with one or more operations of the one or more injection systems [injector] were considered insignificant extra-solution activity in Step 2A, Prong 2. Re-evaluating here in step 2B, these are also determined to be well-understood, routine, conventional activity in the field. The following court decisions indicate that receiving or transmitting data over a network is well-understood, routine, conventional activity in the field: Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
Accordingly, even in combination, these additional elements do not provide significantly more. As such the independent claims 22 and 40 are not patent eligible. (Step 2B: NO. The claims do not provide significantly more).
Dependent claim(s) 23-39 and 42-56 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 an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Dependent claims 23-30 further narrow the additional element of claim 22 of “receiving operation data associated with the one or more injection systems, wherein the operation data includes one or more operation parameters associated with one or more operations of the one or more injection systems.” Specifically, dependent claims 23-25 and 42-44 narrow the “one or more operations” that the operation parameters are associated with and dependent claims 26-30 and 45-49 narrow the operation parameters that “the operation data includes,” and thus narrow the data that is received.
Dependent claim 27 further discloses the additional element of “one or more vibration monitoring sensors configured to measure the vibration frequency and/or amplitude associated with the one or more operations of the one or more injection systems”
Dependent claim 28 further discloses the additional element of “one or more force sensors configured to measure the mechanical force produced by the motor to provide the one or more fluids from the one or more fluid sources.”
Dependent claim 29 further discloses “applying at least one of a cube root life equation and one or more other suitable equations to the flow rate during the one or more injections and the volume pumped and/or delivered during the one or more injections, wherein a maximum achieved pressure is substituted for an average load and the flow rate during the one or more injections and the volume pumped and/or delivered during the one or more injections establishes a duration of a load to determine the one or more prediction scores” This limitation is directed to a mathematical equation which is an abstract idea.
Dependent claim 30 further discloses the additional element of “the one or more image capture devices configured to read at least one barcode.”
Dependent claims 31 and 50 further disclose the additional element of, “wherein the one or more image capture devices are positioned on or recessed in a housing of the injector or within at least a portion of an inner surface of at least one syringe port of the injector.”
Dependent claims 32 and 51 further disclose the additional elements of, “one or more image capture devices positioned to have a field of view that includes one or more components of the one or more injection systems for capturing one or more images of the one or more components of the one or more injection systems” and “using one or more image processing techniques.”
Dependent claims 35 and 54 disclose “wherein the maintenance data includes an instruction to the one or more injection systems that causes the one or more injection system to automatically initiate at least one maintenance action,” and wherein claims 36 and 55 respectively clarify that the, “maintenance action includes at least one of the following,” various actions. However, claim 36 discloses various actions that narrow the abstract idea and therefore, broadly, the claim narrows the abstract idea as the “at least one maintenance action” could be, for example, merely prompting a user to initiate at least one maintenance action (rules or instructions).
In regards to dependent claims 37 and 56, both claims disclose, “wherein the at least one processor is further programmed and/or configured to: automatically disable, based on the maintenance data, the injection system from performing an injection operation.” However, the limitation is broadly claimed as it is not claimed how the processor decides to disable the injection system based on the maintenance data when the claim does not identify what specific maintenance data would result in the injection system being automatically disabled and for what purpose. Therefore, as the claims are currently written, claims 37 and 56 merely describe using computers as mere tools to perform the abstract idea (and thus narrow the rules or instructions to disable, based on the maintenance data, the injection system from performing an injection operation, see MPEP 2106.05(f).)
Dependent claims 38 further disclose the additional element of, “one or more sensors configured to measure the one or more operation parameters associated with the one or more operations of the one or more injection systems, wherein the one or more sensors include at least one of the following sensors: a flow rate sensor; a temperature sensor, and accelerometer; a vibration monitoring sensor, a strain gauge; a motor current sensor; an image sensor; an air sensor; a force sensor; or any combination thereof.”
In particular, the, “one or more vibration monitoring sensors configured to measure the vibration frequency and/or amplitude associated with the one or more operations of the one or more injection systems,” “one or more force sensors configured to measure the mechanical force produced by the motor to provide the one or more fluids from the one or more fluid sources,” “one or more image capture devices configured to read at least one barcode, wherein the one or more image capture devices are positioned on or recessed in a housing of the injector or within at least a portion of an inner surface of at least one syringe port of the injector,” “one or more sensors configured to measure the one or more operation parameters associated with the one or more operations of the one or more injection systems, wherein the one or more sensors include at least one of the following sensors: a flow rate sensor; a temperature sensor, and accelerometer; a vibration monitoring sensor, a strain gauge; a motor current sensor; an image sensor; an air sensor; a force sensor; or any combination thereof,” merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(1) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application.
Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the, “one or more vibration monitoring sensors configured to measure the vibration frequency and/or amplitude associated with the one or more operations of the one or more injection systems,” “one or more force sensors configured to measure the mechanical force produced by the motor to provide the one or more fluids from the one or more fluid sources,” “one or more image capture devices configured to read at least one barcode, wherein the one or more image capture devices are positioned on or recessed in a housing of the injector or within at least a portion of an inner surface of at least one syringe port of the injector,” “one or more sensors configured to measure the one or more operation parameters associated with the one or more operations of the one or more injection systems, wherein the one or more sensors include at least one of the following sensors: a flow rate sensor; a temperature sensor, and accelerometer; a vibration monitoring sensor, a strain guage; a motor current sensor; an image sensor; an air sensor; a force sensor; or any combination thereof,” were considered 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 been found insufficient to provide significantly more. MPEP2106.05 (A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide an inventive concept (‘significantly more"). Accordingly, even in combination, these additional element do not provide significantly more.
Therefore, the dependent claims are also directed to an abstract idea.
Thus, Claims 23-58 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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) 22-26, 33-45, and 52-58 are rejected under 35 U.S.C. 103 as being unpatentable over Sehgal (US PG Pub 2014/0266713 A1) in view of Galt (US PG Pub 2007/0293977 A1).
Regarding Claim 22, Sehgal discloses:
A predictive maintenance system comprising:
one or more injection systems including an injector configured to provide one or more fluids from one or more fluid sources; (Para 36-39 discloses Medical device 140 can have components 205A, 205B, and 205C that can be used during operation of the medical device. For example, medical device 140 can correspond to a peristaltic pump, and components 205A, 205B, and 205C can correspond to pumping fingers associated with the peristaltic pump. Para 43 discloses if component 205B corresponds to a motor in an infusion pump, and sensor 210B measures the distance that the motor turns to pump medication, then the corresponding maintenance threshold value can indicate the maximum distance that the motor can turn before motor service should be performed.)
a computer system comprising one or more processors programmed or configured to: (Para 30 discloses In particular, aspects of the computing landscape 100 can be implemented in a computing system that includes a back-end component (e.g., as a data server 110), or that includes a middleware component (e.g., an application server 115), or that includes a front-end component (e.g., a client computer 120 having a graphical user interface or a Web browser through which a user may interact with an implementation of the subject matter described herein), or any combination of such back-end, middleware, or front-end components. Para 56 discloses one or more aspects or features of the subject matter described herein can be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and/or combinations thereof. These various implementations may include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device (e.g., mouse, touch screen, etc.), and at least one output device.)
receive operation data associated with the one or more injection systems, wherein the operation data includes one or more operation parameters associated with one or more operations of the one or more injection systems; (Para 36-39 discloses Medical device 140 can have components 205A, 205B, and 205C that can be used during operation of the medical device. For example, medical device 140 can correspond to a peristaltic pump, and components 205A, 205B, and 205C can correspond to pumping fingers associated with the peristaltic pump. Para 43 discloses if component 205B corresponds to a motor in an infusion pump, and sensor 210B measures the distance that the motor turns to pump medication, then the corresponding maintenance threshold value can indicate the maximum distance that the motor can turn before motor service should be performed. Paras 42-43 disclose as components 205A, 205B, and 205C experience wear and tear from day-to-day use, these components can require maintenance. Processor 220 in medical device 140 can be configured to determine whether maintenance is required by comparing a measured parameter value 320 for a component with a corresponding maintenance threshold value. Application server 115 can transmit maintenance threshold values to medical device 140 which, in turn, can store this data in memory 215… For example, if component 205A corresponds to a plunger in a syringe, and sensor 210A measures how many times the plunger in the syringe moves, then the corresponding maintenance threshold value can indicate the maximum number of times that the plunger can move before the syringe should be serviced or replaced)
provide maintenance data associated with the one or more operation failures or misuses, wherein the maintenance data is determined based on the one or more prediction scores. (Fig 4 discloses suggested maintenance 425 such as replace touch screen, replace plunger, recalibrate internal clock. Para 12 discloses the medical device can display the alert when the measured parameter value is less than the maintenance threshold value and equal to a predetermined percentage of the maintenance threshold value. Moreover, the alert can display an estimate of when maintenance will be needed and a suggested maintenance for the at least one component associated with the parameter type.)
While Sehgal discloses the above limitations, it does not fully disclose the following limitation that Galt discloses:
determine one or more prediction scores for the one or more injection systems based on the operation data, wherein the one or more prediction scores include one or more predictions of one or more operation failures or misuses for the one or more injection systems; and (Para 55 discloses preventative maintenance information 601 can be represented on the human machine interface screen as an overall "health" score. 605… Alternatively, health score 605 could be an abstracted value of the molding system 100's operational health. For example, in a simple arrangement, health score 605 could start at 100%, but be reduced by 5% for every real time operational parameters 606 that is detected out of its preferred operational range. It is contemplated that the adjustment to health score 605 could be related to the degree that an operational parameter 606 is detected out of operational range. Thus, if hydraulic pressure is determined to be below a minimum operational limit by a first amount, then health score 605 would be decreased 5%, but if hydraulic pressure is determined to be below the minimum operational limit by a second amount, then health score 605 would be decreased 10%. It is further contemplated that the adjustments to the health score 605 could be weighted based on the severity of the out-of-limits condition. Thus, if sensors measure that the oil is contaminated by particulates above a maximum value, then health score 605 could be decreased by a greater amount than if the operational temperature of the system is too high. Para 83 discloses when an out of tolerance condition is detected by the comparator module 602 which could lead to an instability or failure of the molding system 100, preventative maintenance of this issue is scheduled into the next available service event.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the predictive maintenance for medical devices as taught by Sehgal with the preventative maintenance indicator system as taught by Galt in order to clearly indicate the performance ability of a machine either visually or through a numerical score to determine the need for preventative maintenance.
Regarding Claim 23, this claim recites the limitations of Claim 22 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt discloses the following limitation that Sehgal further discloses:
The predictive maintenance system of claim 22, wherein the one or more operations include at least one of the following operations of the one or more injection systems: a hardware operation of one or more hardware components… or any combination thereof. (Para 36-39 discloses medical device 140 can have components 205A, 205B, and 205C that can be used during operation of the medical device. For example, medical device 140 can correspond to a peristaltic pump [a hardware operation of one or more hardware components], and components 205A, 205B, and 205C can correspond to pumping fingers associated with the peristaltic pump. Para 43 discloses if component 205B corresponds to a motor in an infusion pump, and sensor 210B measures the distance that the motor turns to pump medication, then the corresponding maintenance threshold value can indicate the maximum distance that the motor can turn before motor service should be performed.)
While Sehgal discloses the above limitations, the combination of Sehgal and Galt further discloses the following limitation that Galt discloses:
a mechanical operation… or any combination thereof (Para 25 discloses the molding system includes an injection unit 108 for creating a shot of melt. A drive 118 provides operational power for rotating and translating a screw (not shown). The drive 118 may be electric, hydraulic, or a combination of hydraulic and electric. A barrel 109 of the injection unit 108 includes heaters (not shown) to assist melting the raw material. Alternatively, the injection unit 108 could comprise a well-known shooting pot style of injection unit. Para 49 discloses the real time operational parameters 606 may include real time measurements of voltage, current, pressure, temperature, humidity, acidity, alkalinity, stress, strain, viscosity, fluid cleanliness, alignment, and mold part quality, machine vibrations, amongst others, as measured in real time from the sensors 612. Para 51 discloses the comparator module 602 compares the real time operational parameters 606 with the real time threshold data 616 to determine if a component is running within the normal range, below a minimum operational limit, or above a maximum operational limit, or a rate of change or frequency towards an operational limit. Para 52 discloses if the comparator module 602 determines the component is running below the minimum operational limit or above a maximum operational limit, for the case wherein this is not allowed, the comparator module 602 will trigger an indicator module 604 to generate an alert notice for preventative maintenance.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the predictive maintenance for medical devices as taught by Sehgal with the preventative maintenance indicator system as taught by Galt in order to clearly indicate the performance ability of an injection unit either visually or through a numerical score to determine the need for preventative maintenance.
Regarding Claim 24, this claim recites the limitations of Claim 23 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt discloses the following limitation that Sehgal further discloses:
The predictive maintenance system of claim 23, wherein the one or more operations include the hardware operation of the one or more hardware components, and wherein the one or more hardware components include at least one of the following hardware components of the one or more injection systems: a microprocessor, a memory, a storage component, an input component, an output component, a circuit board, a sensor, a pump, a valve, or any combination thereof. (Para 36 discloses medical device 140 can have components 205A, 205B, and 205C that can be used during operation of the medical device. For example, medical device 140 can correspond to a peristaltic pump, and components 205A, 205B, and 205C can correspond to pumping fingers associated with the peristaltic pump.)
Regarding Claim 25, this claim recites the limitations of Claim 23 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt discloses the following limitation that Galt further discloses:
The predictive maintenance system of claim 23, wherein the one or more operations include the mechanical operation, and wherein the mechanical operation includes providing the one or more fluids from the one or more fluid sources. (Para 29 discloses The molding system includes an injection unit 108 for creating a shot of melt. A drive 118 provides operational power for rotating and translating a screw (not shown). The drive 118 may be electric, hydraulic, or a combination of hydraulic and electric. A barrel 109 of the injection unit 108 includes heaters (not shown) to assist melting the raw material. Alternatively, the injection unit 108 could comprise a well-known shooting pot style of injection unit. Para 52 discloses the real time operational parameters 606 may include real time measurements of voltage, current, pressure, temperature, humidity, acidity, alkalinity, stress, strain, viscosity, fluid cleanliness, alignment, and mold part quality, machine vibrations, amongst others, as measured in real time from the sensors 612.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the predictive maintenance for medical devices as taught by Sehgal with the preventative maintenance indicator system as taught by Galt in order to clearly indicate the performance ability of a machine either visually or through a numerical score to determine the need for preventative maintenance.
Regarding Claim 26, this claim recites the limitations of Claim 22 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt discloses the following limitation that Sehgal further discloses:
The predictive maintenance system of claim 22, wherein the one or more operation parameters include at least one of the following operation parameters associated with the one or more operations of the one or more injection systems: a duration of time powered-on; a number of times power has been cycled; or any combination thereof. (Para 39 discloses if the peristaltic pump is battery operated, then sensor 210A can also record the number of times that the battery of the pump charges and discharges as well as its charge time and how long the battery remains on.)
While Sehgal discloses the above limitations, the combination of Sehgal and Galt further discloses the following limitation that Galt discloses:
wherein the one or more operation parameters include at least one of the following operation parameters associated with the one or more operations of the one or more injection systems: number of injections performed; (Para 55 discloses for the case where this is allowed for a period of time, or for a predefined number of occurrences exceeding the operational range without damage, then the comparator module 602 checks the history module 608 to determine the frequency information and data to see if the maximum frequency of this value has been exceeded and trigger the indicator module 604 to generate the alert notice indicating preventative maintenance is required.)
a current; a voltage; an achieved pressure; a temperature and/or a humidity of an environment surrounding the one or more injection systems; (Para 48 discloses the real time preventative maintenance system 600 may include threshold data 616 for many operational measurements, such as voltage parameters, current parameters, pressure parameters, temperature parameters, humidity parameters, acidity parameters, alkalinity parameters, stress parameters, strain parameters, viscosity parameters, alignment parameters, machine vibration parameters and molded part quality parameters. Para 52 discloses the real time operational parameters 606 may include real time measurements of voltage, current, pressure, temperature, humidity, acidity, alkalinity, stress, strain, viscosity, fluid cleanliness, alignment, and mold part quality, machine vibrations, amongst others, as measured in real time from the sensors 612. Para 55 discloses using the data provided by history module 608, comparator module 602 can determine the frequency of occurrence in measured operational values, the rate of change, or determine trend lines (typically indicating a loss of performance).
a temperature over one or more time periods within the one or more injection systems; or any combination thereof (Para 48 discloses the real time preventative maintenance system 600 may include threshold data 616 for many operational measurements, such as… temperature parameters…Para 55 discloses using the data provided by history module 608, comparator module 602 can determine the frequency of occurrence in measured operational values, the rate of change, or determine trend lines (typically indicating a loss of performance) [thus over one or more time periods].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the predictive maintenance for medical devices as taught by Sehgal with the preventative maintenance indicator system as taught by Galt in order to clearly indicate the performance ability of a machine either visually or through a numerical score to determine the need for preventative maintenance and to determine the frequency of occurrence in measured operational values, the rate of change, or determine trend lines (typically indicating a loss of performance) of various operational values to get the most accurate value of a health score of the machine.
Regarding Claim 33, this claim recites the limitations of Claim 22 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt discloses the following limitation that Sehgal further discloses:
The predictive maintenance system of claim 22, wherein the maintenance data includes a prompt to a user to initiate at least one maintenance action associated with the one or more injection systems. (Fig 4 discloses suggested maintenance 425 such as replace touch screen, replace plunger, recalibrate internal clock. Para 12 discloses the medical device can display the alert when the measured parameter value is less than the maintenance threshold value and equal to a predetermined percentage of the maintenance threshold value. Moreover, the alert can display an estimate of when maintenance will be needed and a suggested maintenance for the at least one component associated with the parameter type.)
Regarding Claim 34, this claim recites the limitations of Claim 33 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt discloses the following limitation that Sehgal further discloses:
The predictive maintenance system of claim 33, wherein the at least one maintenance action includes at least one of the following maintenance actions: scheduling a service for the one or more injection systems; operating the one or more injection systems in a specific manner indicated by the maintenance data; requesting a service directly from the one or more injection systems; or any combination thereof. (Paras 11-12 disclose the alert can be displayed on the medical device when the measured parameter value meets or exceeds the maintenance threshold value. The alert can display a suggested maintenance for the at least one component associated with the parameter type [thus disclosing requesting a service directly from the one or more injection systems (displayed on the medical device)]. The medical device or at least one component can be rendered inoperable until the suggested maintenance is performed [thus disclosing operating the one or more injection systems in a specific manner indicated by the maintenance data]… The medical device can display the alert when the measured parameter value is less than the maintenance threshold value and equal to a predetermined percentage of the maintenance threshold value. Moreover, the alert can display an estimate of when maintenance will be needed and a suggested maintenance for the at least one component associated with the parameter type.)
Regarding Claim 35, this claim recites the limitations of Claim 22 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt discloses the following limitation that Sehgal further discloses:
The predictive maintenance system of claim 22, wherein the maintenance data includes an instruction to the one or more injection systems that causes the one or more injection systems to automatically initiate at least one maintenance action. (Fig 4 discloses suggested maintenance 425 such as replace touch screen, replace plunger, recalibrate internal clock. Para 12 discloses the medical device can display the alert when the measured parameter value is less than the maintenance threshold value and equal to a predetermined percentage of the maintenance threshold value. Moreover, the alert can display an estimate of when maintenance will be needed and a suggested maintenance for the at least one component associated with the parameter type.)
Regarding Claim 36, this claim recites the limitations of Claim 35 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt discloses the following limitation that Sehgal further discloses:
The predictive maintenance system of claim 35, wherein the at least one maintenance action includes at least one of the following: prompt to a user to initiate at least one maintenance action associated with the one or more injection systems; transmitting operation data and/or an alert to a remote system; providing remote entry to a remote computing system to modify and/or update software and/or the one or more operation parameters; scheduling a service technician; performing a specific operation; providing a recommendation to improve service based on a comparison of the one or more injection systems to one or more other injection systems; rebooting software of the one or more injection systems; updating the software of the one or more injection systems; offering a customized preventative maintenance service; offering a service plan based on usage-based operation parameters; disabling or limiting one or more operations or functions; cycling power, disabling power; recommending training to a user; measuring component degradation, wear, or cleanliness; providing instructions to use the one or more injection systems in a specific manner to avoid a specific operation failure and/or misuse; placing an order for one or more disposables and/or one or more contrast agents; or any combination thereof. (Fig 4 discloses suggested maintenance 425 such as replace touch screen, replace plunger, recalibrate internal clock. Para 12 discloses the medical device can display the alert when the measured parameter value is less than the maintenance threshold value and equal to a predetermined percentage of the maintenance threshold value. Moreover, the alert can display an estimate of when maintenance will be needed and a suggested maintenance for the at least one component associated with the parameter type.)
Regarding Claim 37, this claim recites the limitations of Claim 22 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt discloses the following limitation that Sehgal further discloses:
The predictive maintenance system of claim 22, wherein the at least one processor is further programmed and/or configured to: automatically disable, based on the maintenance data, the one or more injection systems from performing an injection operation. (Para 11 discloses the medical device or at least one component can be rendered inoperable until the suggested maintenance is performed. Para 45 discloses based on this comparison, processor 220 can generate an alert to be displayed on display 230 of medical device 140 when the measured parameter value 320 meets or exceeds the corresponding maintenance threshold value. When these conditions are met, the medical device 140 or the affected component can be automatically turned off or otherwise rendered inoperable until the suggested maintenance is performed. The alert can also display the affected component and the suggested maintenance for the affected component.)
Regarding Claim 38, this claim recites the limitations of Claim 22 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt discloses the following limitation that Sehgal further discloses:
The predictive maintenance system of claim 22, further comprising: one or more sensors configured to measure the one or more operation parameters associated with the one or more operations of the one or more injection systems, wherein the one or more sensors include at least one of the following sensors: a flow rate sensor; a temperature sensor; an accelerometer; a vibration monitoring sensor; a strain gauge; a motor current sensor; an image sensor; an air sensor; a force sensor; or any combination thereof. (Paras 36-37 discloses referring now to FIG. 2, the injection unit 108 is further described. The drive 118 may include sensors 202. For an electric drive typical sensors 202 include those for temperature, voltage, and current. For a hydraulic drive, typical sensors 202 include those for temperature and hydraulic pressure… The injection unit 108 also includes sensors 204 along a length of the barrel 109 for sensing temperature. The sensors 204 are also capable of measuring voltage, and current supplied to the electrical barrel heaters.)
Regarding Claim 39, this claim recites the limitations of Claim 22 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt discloses the following limitation that Galt further discloses:
The predictive maintenance system of claim 22, wherein the one or more operation failures or misuses for the one or more injection systems include at least one of the following:… failure of a mechanical component… or any combination thereof (Para 15 discloses a technical effect, amongst other technical effects, of the present invention is real time sensing of operational data for assessment by the system to predict or indicate a potential failure in advance of actual failure. Indicating potential failures in advance of actual failures provides better up-time to customers. Para 25 discloses the molding system includes an injection unit 108 for creating a shot of melt. A drive 118 provides operational power for rotating and translating a screw (not shown). The drive 118 may be electric, hydraulic, or a combination of hydraulic and electric. A barrel 109 of the injection unit 108 includes heaters (not shown) to assist melting the raw material. Alternatively, the injection unit 108 could comprise a well-known shooting pot style of injection unit. Para 49 discloses the real time operational parameters 606 may include real time measurements of voltage, current, pressure, temperature, humidity, acidity, alkalinity, stress, strain, viscosity, fluid cleanliness, alignment, and mold part quality, machine vibrations, amongst others, as measured in real time from the sensors 612. Para 51 discloses the comparator module 602 compares the real time operational parameters 606 with the real time threshold data 616 to determine if a component is running within the normal range, below a minimum operational limit, or above a maximum operational limit, or a rate of change or frequency towards an operational limit [towards failure]. Para 52 discloses if the comparator module 602 determines the component is running below the minimum operational limit or above a maximum operational limit, for the case wherein this is not allowed, the comparator module 602 will trigger an indicator module 604 to generate an alert notice for preventative maintenance. Para 58 discloses the updater module 614 indicates trends towards a failure as well as failure when it occurs. (See further: Para 53).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the predictive maintenance for medical devices as taught by Sehgal with the preventative maintenance indicator system as taught by Galt in order to clearly indicate the performance ability of a machine either visually or through a numerical score to determine the need for preventative maintenance and in order to indicate potential failures in advance of actual failures provides better up-time to customers.
Regarding claim 40, the claims are directed to the computer program product of the system of claim 1 and further recite at least one non-transitory computer-readable medium including program instructions that, when executed by at least one processor, cause the at least one processor to [perform the method] (e.g., see Sehgal Para 18 teaching processor and computer program products) and is similarly rejected.
Regarding claim 41-45 and 52-58, the claims are directed to a system reciting the same limitations of the system of claims 22-26 and 33-39 and further recites the following limitation specifically of claim 38, “one or more sensors configured to measure one or more operations parameters associated with the one or more operations of the injector,” (see above rejection) and thus, are similarly rejected.
Claim(s) 27 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Sehgal (US PG Pub 2014/0266713 A1) in view of Galt (US PG Pub 2007/0293977 A1), further in view of Dai (Condition monitoring on complex machinery for predictive maintenance and process control).
Regarding Claim 27, this claim recites the limitations of Claim 26 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt does not fully disclose the following limitation that Dai discloses:
The predictive maintenance system of claim 26, wherein the one or more operation parameters include the vibration frequency and/or amplitude associated with the one or more operations of the one or more injection systems, and wherein the one or more prediction scores include one or more predictions of one or more operation failures or misuses for the one or more injection systems associated with a build-up of wear, contrast and/or dirt in connection therewith such that an effect of the build-up of wear, contrast and/or dirt for each of the one or more injection systems is determined by applying a pattern prediction model to the vibration frequency and/or amplitude over one or more time periods (Section I Introduction discloses a frequency analysis of the vibration will give a much earlier warning of the fault, since it is selective, and will allow the increasing vibration at the frequency associated with the fault to be identified [9]. Machine condition, machine faults and on-going damage can be identified in operating machines by fault symptoms. Therefore vibration analysis can identify developing problem before they become too serious and cause breakage, using vibration and noise analysis, the condition of a machine can be constantly monitored and more detailed analyses can be made to determine the health of a machine and identify any faults that may be arising or that already exist. Section III(B) Important Vibration Monitoring Signal Process FFT Analysis discloses a frequency analysis of the vibration will give a much earlier warning of the fault, since it is selective, and will allow the increasing vibration at the frequency associated with the fault to be identified [wherein the vibration value is the score indicating build-up of wear].)
the predictive maintenance system further comprises: one or more vibration monitoring sensors configured to measure the vibration frequency and/or amplitude associated with the one or more operations of the one or more injection systems, wherein (Section III(A) Vibration Measurement and Sensor Choices discloses to the fulfillment of the demands on comprehensive vibration and noise analysis, an aimed instrumentation of the unit to be supervised is required whereby displacement, velocity, acceleration and pick-ups are used. Also microphones are used to acquire noise signal. Mathematically, these basic descriptive values can be transformed one to the other by integration respectively by differentiation [2]. Practically, the choice of sensors depends on the excitations to be determined. Accelerometers show a constant amplitude behavior over a wide frequency range; therefore, they can be used to detect low and high frequent signal intensities [and further discloses velocity transducers, thus disclosing one or more vibration monitoring sensors].)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of the predictive maintenance for medical devices as taught by Sehgal and the preventative maintenance indicator system as taught by Galt with the frequency analysis of the vibration as taught by Dai in order to obtain a much earlier warning of the fault (Section 1 Introduction).
Regarding claim 46, the claims are directed to a system reciting the same limitations of the system of claim 27 and thus, is similarly rejected.
Claim(s) 28 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Sehgal (US PG Pub 2014/0266713 A1) in view of Galt (US PG Pub 2007/0293977 A1), further in view of Van Der Merwe (US PG Pub 2016/0003242 A1).
Regarding Claim 28, this claim recites the limitations of Claim 26 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt does not fully disclose the following limitation that Van Der Merwe discloses:
The predictive maintenance system of claim 26, wherein the one or more operation parameters include the mechanical force produced by the motor, and wherein the predictive maintenance system further comprises: one or more force sensors configured to measure the mechanical force produced by the motor to provide the one or more fluids from the one or more fluid sources, wherein the one or more prediction scores include one or more predictions of one or more operation failures or misuses for the one or more injection systems associated with a build-up of wear, contrast and/or dirt in connection therewith such that an effect of the build-up of wear, contrast and/or dirt for each of the one or more injection systems is determined by a comparison of the force of the motor thereof for a current or more recent injection operation to the force of the motor thereof for one of previous injection operations and a calibration operation of the motor. (Abstract discloses a pumping system and method for operating a pumping system including a motor coupled to a variable speed drive to drive a pump. A torque indicator corresponding to the torque presented to the drive is determined. The torque indicator may be used to detect a fault if it exceeds a baseline torque, or to detect a defective transducer, or to detect a system change by perturbing one parameter and comparing another to a predicted value. Para 12 discloses the method executed by the processor comprises: determining a torque indicator comprising one of torque, motor power and motor current; determining the torque indicator during a fault calibration period [a calibration operation of the motor] to determine a baseline [thus the indicator value that determines the baseline is the previous injection operation]; setting a fault threshold based on the baseline; and after setting the fault threshold, detecting a fault if the torque indicator exceeds the fault threshold [wherein the score is the change in torque that results in the indicator exceeding the fault threshold and thus indicates a build-up of wear].)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of the predictive maintenance for medical devices as taught by Sehgal and the preventative maintenance indicator system as taught by Galt with utilizing the torque indicator as taught by Van Der Merwe in order to detect a fault, a defective transducer, or a system change of a pumping system.
Regarding claim 47, the claims are directed to a system reciting the same limitations of the system of claims 28 and thus, is similarly rejected.
Claim(s) 29 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Sehgal (US PG Pub 2014/0266713 A1) in view of Galt (US PG Pub 2007/0293977 A1), further in view of P. Evans (Volume flow rate explained), Luetzenberger (Improving Product-Service Systems by Exploiting Information From The Usage Phase. A Case Study.) and Rochambeau (Fluid Power - Introduction to Pressure: The Basics).
Regarding Claim 29, this claim recites the limitations of Claim 26 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt discloses the following limitation that Galt further discloses:
The predictive maintenance system of claim 26, wherein… the one or more prediction scores include one or more predictions of one or more operation failures or misuses for the one or more injection systems associated with a build-up of wear, contrast and/or dirt in connection therewith such that (Para 58 discloses preventative maintenance information 601 can be represented on the human machine interface screen as an overall "health" score. 605… Alternatively, health score 605 could be an abstracted value of the molding system 100's operational health. For example, in a simple arrangement, health score 605 could start at 100%, but be reduced by 5% for every real time operational parameters 606 that is detected out of its preferred operational range. It is contemplated that the adjustment to health score 605 could be related to the degree that an operational parameter 606 is detected out of operational range. Thus, if hydraulic pressure is determined to be below a minimum operational limit by a first amount, then health score 605 would be decreased 5%, but if hydraulic pressure is determined to be below the minimum operational limit by a second amount, then health score 605 would be decreased 10%. It is further contemplated that the adjustments to the health score 605 could be weighted based on the severity of the out-of-limits condition. Thus, if sensors measure that the oil is contaminated by particulates above a maximum value, then health score 605 could be decreased by a greater amount than if the operational temperature of the system is too high.)
While the combination of Sehgal and Galt discloses the above limitation, it does not fully disclose the following limitation that P. Evans discloses:
wherein the one or more operation parameters include the flow rate during the one or more injections and the volume pumped and/or delivered during the one or more injections, and wherein… the flow rate during the one or more injections and the volume pumped and/or delivered during the one or more injections establishes a duration of a load to determine the one or more prediction scores. (Volume flow rate is the measurement of how much fluid is flowing past a selected point over a length of time. Just let the fluid flow into a measuring tank over a period of time then divide the measured volume (m3) by the length of time (s) to get m3/s. [Thus further disclosing that time (duration of load) can calculated through the same equation described. The reference describes that volume flow rate = volume / time, therefore, it would have been obvious to use volume flow rate and volume to calculate how time (duration of load) by rearranging the equation as time = volume / volume flow rate].)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of the predictive maintenance for medical devices as taught by Sehgal and the preventative maintenance indicator system as taught by Galt with the volume flow rate equation as taught by P. Evans in order to establish the relationship between volume flow rate, volume, and time.
While the combination of Sehgal, Galt, and P. Evans discloses the above limitation, it does not fully disclose the following limitation that Luetzenberger discloses:
an effect of the build-up of wear, contrast and/or dirt for each of the one or more injection systems is determined by applying at least one of a cube root life equation and one or more other suitable equations the flow rate during the one or more injections and the volume pumped and/or delivered during the one or more injections, wherein (Section 4.2 discloses the OutputParameter “Force acting on bearing A” is one major input for calculating the lifetime of bearings (represented as bearing load P in the equation – Figure 9). In addition, the lifetime equation requires P, n, C, Lh as parameters (thus visualized each by a rectangle). The dynamic load rating C is treated as an Output-Parameter, since this parameter enables the selection of an appropriate bearing in standard part catalogues. The lifetime Lh usually relates to product requirements or a specification sheet but can also be related to an average lifetime of past products. The number of spins n is also related to PUI data sets using the Statistical Element Arithmetic Mean.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of the predictive maintenance for medical devices as taught by Sehgal, the preventative maintenance indicator system as taught by Galt and the volume flow rate equation as taught by P. Evans with the improving product-service systems by exploiting information from the usage phase as taught by Lutzenberger in order to establish the relationship between the force acting on a bearing, the average number of spins, the bearings constant, and the lifetime in order to calculate the lifetime of bearings of a machine.
While the combination of Sehgal, Galt, P. Evans, and Luetzenberger discloses the above limitation, it does not fully disclose the following limitation that Rochambeau discloses
a maximum achieved pressure is substituted for an average load (As we've already discussed Pressure is equivalent to force per area. Therefore, we can see that if pressure equals force divided by area, then Force would equal pressure multiplied by area or F [load] = PA.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of the predictive maintenance for medical devices as taught by Sehgal, the preventative maintenance indicator system as taught by Galt, the volume flow rate equation as taught by P. Evans, and the improving product-service systems by exploiting information from the usage phase as taught by Lutzenberger with the introduction to pressure in fluid power as taught by Rochambeau in order to establish the relationship between force, pressure, and area in order to calculate the lifetime of a pump component using pressure to determine when maintenance is required.
Regarding claim 48, the claims are directed to a system reciting the same limitations of the system of claims 29 and thus, is similarly rejected.
Claim(s) 30 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Sehgal (US PG Pub 2014/0266713 A1) in view of Galt (US PG Pub 2007/0293977 A1), further in view of Boissy (Usability of a barcode scanning system as a means of data entry on a PDA for self-report health outcome questionnaires: a pilot study in individuals over 60 years of age).
Regarding Claim 30, this claim recites the limitations of Claim 26 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt does not fully disclose the following limitation that Boissy discloses:
The predictive maintenance system of claim 26, wherein the one or more operation parameters include the number of scans performed by the one or more image capture devices before the successful scan of the at least one bar code, and wherein the predictive maintenance system further comprises: the one or more image capture devices configured to read at least one barcode. (The responsiveness of the scanning system, expressed as first scan success rate, was less than perfect, with approximately one-third of first scans requiring a rescan to successfully capture the data entry. )
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of the predictive maintenance for medical devices as taught by Sehgal and the preventative maintenance indicator system as taught by Galt with the scanning system as taught by Boissy in order to properly identify the number of scans a barcode scanner required before successfully capture the data entry in order to determine efficiency of the scanner to determine if maintenance is required.
Regarding claim 49, the claims are directed to a system reciting the same limitations of the system of claims 30 and thus, is similarly rejected.
Claim(s) 31 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Sehgal (US PG Pub 2014/0266713 A1) in view of Galt (US PG Pub 2007/0293977 A1), further in view of Boissy (Usability of a barcode scanning system as a means of data entry on a PDA for self-report health outcome questionnaires: a pilot study in individuals over 60 years of age) and R. Evans (US PG Pub 2006/0144942 A1).
Regarding Claim 31, this claim recites the limitations of Claim 30 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal, Galt, and Boissy does not fully disclose the following limitation that R. Evans discloses:
The predictive maintenance system of claim 30, wherein the one or more image capture devices are positioned on or recessed in a housing of the injector or within at least a portion of an inner surface of at least one syringe port of the injector. (Para 60 discloses a syringe label cradle unit (SLCU) 120. The SLCU 120 includes a syringe label cradle (SLC) 122 and a syringe 124 having a needle 126 and a plunger 128 which slides within syringe barrel 130 [syringe port]… Para 69 discloses referring to FIG. 8, there is shown the incorporation of two detectors 160, 162 within the housing 158 of the scanner module 156 [thus one or more image capture devices positioned on or recessed in a housing of the injector]. In the preferred embodiment, the detectors 160, 162 are in the nature of linear barcode scanners or a raster scanner operative for reading bar or other machine readable code for providing drug administration information… Para 71 discloses referring to FIG. 11, there is diagrammatically shown the scanner module 156 in fully assembled form including detectors 160, 162, 166, microprocessor 154 and storage device 164. As shown, the components of the scanner module 156 are all internal within the housing, as well as the position of the drug administration information 118, 142 on the port cradle 100 and SLCU 120.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of the predictive maintenance for medical devices as taught by Sehgal, the preventative maintenance indicator system as taught by Galt and the scanning system as taught by Boissy with the detectors on the housing as taught by R. Evans in order to acquire administration information of a syringe via the housing of the injector to more efficiently and accurately administer the liquid of the syringe.
Regarding claim 50, the claims are directed to a system reciting the same limitations of the system of claims 31 and thus, are similarly rejected.
Claim(s) 32 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Sehgal (US PG Pub 2014/0266713 A1) in view of Galt (US PG Pub 2007/0293977 A1), further in view of Warwick (US PG Pub 2014/0210984 A1).
Regarding Claim 32, this claim recites the limitations of Claim 22 and as to those limitations is rejected for the same basis and reasons as disclosed above. The combination of Sehgal and Galt does not fully disclose the following limitation that Warwick discloses:
The predictive maintenance system of claim 22, further comprising: one or more image capture devices positioned to have a field of view that includes one or more components of the one or more injection systems for capturing one or more images of the one or more components of the one or more injection systems, wherein the at least one processor is further programmed and/or configured to: analyze the one or more images using one or more image processing techniques to identify at least one of (i) a percentage of the one or more components that are covered in unwanted contaminants and (ii) a leak or a crack in the one or more components, wherein the one or more prediction scores include one or more predictions of one or more operation failures or misuses for the one or more injection systems associated with new or increased contaminant coverage thereon and/or a leak or a crack in the one or more components determined by a comparison of current images to training images or previous images to identify the new or increased contaminant coverage and/or the leak or the crack in the one or more components. (Para 16 discloses embodiments of the present disclosure may provide systems, devices, and methods for detecting a leak within a fluid passage or anticipating a degraded portion of the fluid passage that may lead to a leak (e.g., a significantly weakened fluid passage). For example, certain embodiments may include a thermographic camera directed toward a region including at least one fluid passage. The thermographic camera may be configured to output a signal indicative of a thermographic image of the region to a controller communicatively coupled with the thermographic camera. The controller may be configured to detect a leak or anticipate a leak within the at least one fluid passage based on the signal. For example, the controller may analyze a thermographic image of the region which may include image pattern recognition analysis to determine whether the thermographic image includes an area indicative of a fluid leak or anticipated fluid leak. The controller may also compare a rate of temperature change in a particular area to a threshold value indicative of a fluid leak or anticipated fluid leak [prediction score]. A crack or significantly degraded area in a fluid passage may have an abnormal image pattern as well as an abnormal temperature. For example, a fluid passage may have an abnormally high temperature or abnormal thermographic image pattern near a crack in comparison with surrounding portions of the fluid passage or other components.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of the predictive maintenance for medical devices as taught by Sehgal, the preventative maintenance indicator system as taught by Galt with a thermographic camera directed toward a region including at least one fluid passage as taught by Warwick in order to identify an abnormal image pattern as well as an abnormal temperature in order to identify a fluid leak or anticipated fluid leak.
Regarding claim 51, the claims are directed to a system reciting the same limitations of the system of claims 32 and thus, are similarly rejected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA J MORICE DE VARGAS whose telephone number is (703)756-4608. The examiner can normally be reached M-F 8:30-5:30 pm.
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/SARA JESSICA MORICE DE VARGAS/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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