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 .
Notice to Applicant
This communication is in response to the amendment filed 8/20/2025. Claims 1-5, 7-9, 13, and 14 have been amended. Claims 1-10, 13, and 15 remain pending and have been examined.
Response to Arguments
A. Applicant's arguments with respect to the rejection of claims 1-10, 13, and 14 under 35 USC 101 have been fully considered but they are not persuasive.
Applicant argues starting on page 11 of the response that the claims “do not recite (and do not even involve) a judicial exception of mental processes,” asserting that “Essentially, the Examiner reasons that the recited limitations can be performed in the human mind.” Examiner respectfully disagrees with Applicant’s characterization of the analysis provided under Step 2A Prong 1.
The analysis provided under Step 2A Prong 1 expressly states that the elements construed as falling within the scope of a judicial exception “constitute a form of managing personal behavior and therefore fall within the scope of an abstract idea in the form of a method of organizing human activity.” While the provided rationale goes on to state that a human could perform each of the elements as part of routine monitoring and maintenance of an imaging device, this statement is not an assertion that the claim elements are construed as performed in the human mind. Examiner maintains that the elements listed under Step 2A Prong 1 are properly construed as falling within the scope of a method of organizing human activity, and notes MPEP 2106.04(a)(2)(II) and 2106.04(a)(2)(II)(C) as providing examples of subject matter properly construed as a form of managing personal behavior.
Applicant further argues that the claims as a whole integrate the judicial exception into a practical application under Step 2A Prong 2. Examiner respectfully disagrees.
Applicant first argues that the claims do not monopolize the judicial exception, asserting that “obviously, there are other ways to evaluate a functionality of a medical imaging apparatus.” However, the existence of other ways to evaluate the functionality of a medical imaging apparatus is not itself sufficient to establish that the claims are integrated into a practical application under Step 2A Prong 2.
Applicant further argues that the claims recite an improvement to technology or a technical field, citing to paragraphs 3 and 4 of the specification which assert a need for monitoring a functionality of a medical imaging device during its whole life cycle. Applicant asserts that “it is critical to monitor and evaluate different phases in the life cycle of an imaging apparatus” and that “[a]s now recited in Applicant's claims, the functionality of the medical imaging apparatus can be evaluated during an entire life cycle of the medical imaging apparatus, and where the entire life cycle comprises the different life cycle phases.” Examiner respectfully disagrees. As set out in Step 2A Prong 2 below, evaluating the functionality of the medical imaging apparatus during an entire life cycle falls within the scope of the abstract idea and does not constitute an additional element. See MPEP 2106.05(a)(“It is important to note, the judicial exception alone cannot provide the improvement”) Furthermore, a statement that the goal of the claimed invention, such as monitoring functionality of the medical imaging apparatus during an entire life cycle, is desirable is not sufficient to establish that the claim recites additional elements which amount to an improvement to technology or a technical field.
Similarly, the use of a generic computer processor to perform the data analysis functions listed by Applicant only amounts to mere instructions to implement those functions using a computer as a tool, and does not constitute an improvement to technology. As provided in MPEP 2106.05(f)(2), “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.”
Applicant lastly asserts on page 12 that the claims recite limitations which qualify as significantly more than the abstract idea “by making improvements to the technology or technical field, as discussed above.” Examiner respectfully disagrees. As explained above, the claims do not recite elements which amount to or yield an improvement to technology or a technical field. The computing elements such as the recited sensor and processor are only recited as instructions to implement functions using general computing elements as tools.
The rejection of claims 1-10, 13, and 14 under 35 USC 101 is maintained.
B. Applicant's arguments with respect to the rejection of claims 1-10, 13, and 14 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues starting on page 14 that the cited Choubey and Powers references do not teach or suggest “wherein the processor is further configured to determine a present life cycle phase of the medical imaging apparatus.” Examiner respectfully disagrees.
Applicant asserts that cited paragraphs 43-45, 53, and 62 do not teach this function, stating that “according to Choubey, the sensor data evaluation is within each phase cycle, which is not relevant to the Applicant's limitation.” However, the argued limitation does not recite any specific mechanism by which the processor determines a present life cycle phase, and does not recite doing so using data from the sensor. The broadest reasonable interpretation of a processor “determining” a present life cycle phase encompasses any manner of obtaining a present life cycle phase. Cited paragraphs 43-45, 53, and 62 describe functions in which the processor uses the present life cycle phase as part of its monitoring and analysis, i.e. the system knows the present life cycle phase. The processor having this information means that it was determined in some fashion, and the claim does not require any specific manner by which that happens. Examiner therefore maintains that Choubey discloses the argued limitation.
Applicant further argues on page 16 that Powers does not teach controlling the at least one sensor based on the determined present life cycle phase of the medical imaging apparatus. Examiner respectfully disagrees.
Applicant asserts that “In [0013] Powers mentions failing components due to age. The number of uses or age of the device are neither equivalent nor similar to a life cycle phase of the medical imaging apparatus.” As cited and explained in the rejection, paragraphs 29-31 describe measuring a voltage level within the device during self-test operations, which may be performed while the device is not in use, i.e. a life cycle phase, or upon receiving a signal that the device is now in use, i.e. a life cycle phase. Cited paragraphs 18, 19, 35, and 37 describe the device using collected data to control how often the voltage is checked while the device is not in use. Changing the frequency of data collection is construed as a form of controlling the sensor, and this is performed while the device knows it is not in use. Cited paragraph 33 provides an embodiment in which the device determines that it is use based on a manual activation signal, and initiates the self-test upon this determination. Each of these constitutes a form of using a determined current life cycle phase of the device as part of controlling the usage of the voltage sensor. Examiner notes that the argued limitation only recites controlling the sensor “based on” the determined present life cycle phase, which only requires that the present life cycle phase be known and be used as part of how the sensor is controlled.
Applicant lastly asserts that Choubey and Powers do not teach or suggest the newly added subject matter reciting “wherein the functionality of the medical imaging apparatus can be evaluated during an entire life cycle of the medical imaging apparatus, and wherein the entire life cycle comprises the different life cycle phases.” Examiner respectfully disagrees. As cited below, Choubey describes the system monitoring the equipment through its phases of transportation, storage, and normal use in paragraphs 6, 22, and 53, which is construed as within the broadest reasonable interpretation of “an entire life cycle” which comprises the life cycle phases.
The rejection of claims 1-10, 13, and 14 under 35 USC 103 is maintained.
Claim Objections
The previous objection to claim 14 is withdrawn based on the amendment filed 8/20/2025.
Claims 10 and 14 are objected to because of the following informalities:
Claim 10 recites “when the measured parameter of the medical imaging apparatus differ…” which appears to contain a typographical error intended to recite “when the measured parameter of the medical imaging apparatus differs…”.
Appropriate correction is required.
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 1-10, 13, and 14 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 are drawn to a device, while claims 13 and 14 are drawn to a method, each of which is within the four statutory categories.
Step 2A(1)
Claim 1 recites, in part, performing the steps of
measuring at least one parameter of a medical imaging apparatus during different life cycle phases of the medical imaging apparatus;
receiving and analyzing the measured data and analyzing the received data to evaluate, during at least one life cycle phase of the medical imaging apparatus, whether a functionality of the medical imaging apparatus is maintained;
measuring the parameter of the medical imaging apparatus during different life cycle phases of the medical imaging apparatus;
determining a present life cycle phase of the medical imaging apparatus, and controlling at least one sensor based on the determined present life cycle phase of the medical imaging apparatus;
wherein the functionality of the medical imaging apparatus can be evaluated during an entire life cycle of the medical imaging apparatus, and wherein the entire life cycle comprises the different life cycle phases.
These elements constitute a form of managing personal behavior and therefore fall within the scope of an abstract idea in the form of a method of organizing human activity. Fundamentally the process is that of monitoring information from an imaging system to determine whether an element of the imaging system is functional during different phases over its operation life and controlling a sensor based on a current phase. A human could perform each of these functions as part of routine monitoring and maintenance of such an imaging device.
Independent claim 13 recites similar limitations and also recite an abstract idea under the same analysis.
Step 2A(2)
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
Claims 1 and 13 recite additional elements of a) the at least one sensor in its capacity as performing the functions of measuring the at least one parameter, and b) a processor recited as performing functions of receiving and analyzing the measured data to evaluate whether the functionality is maintained, and of determining the present life cycle and controlling the sensor.
Page 7 lines 14-19 describe an acceleration sensor used to measure vibration and acceleration values. Page 10 line 22 – page 23 line 10 describe a plurality of potential parameters measured by the at least one sensor, including acceleration, temperature, humidity, vacuum, voltage, x-ray radiation, rotational speed, and a digital signal of the data processing unit. The sensor is construed as encompassing generic sensors capable of measuring such parameters.
Page 15 lines 28-35 and page 16 lines 7-11 describe a processing unit in terms of its functions including receiving the measured sensor data, controlling the sensor, storing data, and processing received data. No further description of a particular type or structure of a processing unit is provided. The processor is construed accordingly as encompassing a generic computer processor.
Each of these elements only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Particularly, the sensor is recited at a high level of generality as used to measure parameter data, and the processor is likewise recited at a high level of generality as used to perform data processing functions. These elements are not sufficient to integrate the recited abstract idea into a practical application.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1 and 13 only recite the at least one sensor and processor as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f)
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Depending Claims
Claim 2 recites evaluating whether an existing functionality of the medical imaging apparatus is maintained, and confirming whether the functionality can be provided. These limitations fall within the scope of the abstract idea as set out above.
Claim 3 recites wherein the different life cycle phases of the medical imaging apparatus are at least one of: a phase of mounting the medical imaging apparatus, a phase before transporting the medical imaging apparatus, a phase of transporting and storing the medical imaging apparatus, a phase of operating the medical imaging apparatus, and a phase of maintenance of the medical imaging apparatus, and controlling the at least one sensor based on a value of the parameter measured in each respective life cycle phase. These limitations fall within the scope of the abstract idea as set out above.
Claim 3 recites the additional element of the processor as performing the function of controlling the sensor based on the measured parameter values.
Page 15 lines 28-35 and page 16 lines 7-11 describe a processing unit in terms of its functions including receiving the measured sensor data, controlling the sensor, storing data, and processing received data. No further description of a particular type or structure of a processing unit is provided. The processor is construed accordingly as encompassing a generic computer processor.
The recited processor therefore only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the processor is only recited at a high level of generality as used to perform the data processing function of controlling the sensor based on the measured parameter values. The recited processor is therefore not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 4 recites wherein the at least one measured parameter is at least one of: a vibration of a component of the medical imaging apparatus, a vibration of the medical imaging apparatus, an acceleration of a component of the medical imaging apparatus, an acceleration of the medical imaging apparatus, a surrounding temperature of a component of the medical imaging apparatus, a surrounding temperature of the medical imaging apparatus, a surrounding humidity of a component of the medical imaging apparatus, a surrounding humidity of the medical imaging apparatus, a temperature of the medical imaging apparatus, a temperature of a component of the medical imaging apparatus, a mechanical shock of the medical imaging apparatus, a mechanical shock of a component of the medical imaging apparatus, a vacuum parameter of the medical imaging apparatus, an emitter parameter of the medical imaging apparatus, a power supply parameter of the medical imaging apparatus, an over/under voltage parameter of a component of the medical imaging apparatus, an over/under voltage parameter of the medical imaging apparatus, an X-ray radiation parameter of the medical imaging apparatus, a rotation speed of a component of the medical imaging of the apparatus relative to the medical imaging apparatus, a rotation speed of the medical imaging apparatus, an electron beam parameter of the medical imaging apparatus, and a magnetic field parameter of the medical imaging apparatus. These limitations fall within the scope of the abstract idea as set out above.
Claim 5 recites wherein the different life cycle phases of the medical imaging apparatus are determined 1) depending on the measured parameter, 2) autonomously, or 3) based on an external trigger. These limitations fall within the scope of the abstract idea as set out above.
Claim 5 recites the additional elements of a) the at least one sensor as performing the function of measuring the parameter, and b) the monitoring device as performing the function of the autonomous determination of life cycle phase.
As cited above, page 7 lines 14-19 describe an acceleration sensor used to measure vibration and acceleration values. Page 10 line 22 – page 23 line 10 describe a plurality of potential parameters measured by the at least one sensor, including acceleration, temperature, humidity, vacuum, voltage, x-ray radiation, rotational speed, and a digital signal of the data processing unit. The sensor is construed as encompassing generic sensors capable of measuring such parameters.
Page 9 lines 22-27 provide that the determination of the life cycle phase “may be performed autonomously by the monitoring device itself,” that that the autonomous detection “may be determined by identifying typical input data of the sensor.” The monitoring device is described on page 15 line 25 – page 16 line 2 as comprising the sensor which measures parameters and the processing unit which determines the life cycle phase. The monitoring device in this context is therefore construed as encompassing generic computing elements, as outlined above, implementing the function.
The above elements only amount to mere instructions to implement functions within the abstract idea using computing elements as tools. For example, the at least one sensor is only recited at a high level of generality as performing data collection via measuring the parameter, while the monitoring device is only recited at a high level of generality as used to perform the determination autonomously. The above elements are therefore not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 6 recites controlling a signal condition of the sensor and/or an analysis of the measured parameter based on the determined life cycle phase of the medical imaging apparatus. These limitations fall within the scope of the abstract idea as set out above.
Claim 6 recites the additional element of the processor as performing the function of controlling the signal condition or analysis.
Page 15 lines 28-35 and page 16 lines 7-11 describe a processing unit in terms of its functions including receiving the measured sensor data, controlling the sensor, storing data, and processing received data. No further description of a particular type or structure of a processing unit is provided. The processor is construed accordingly as encompassing a generic computer processor.
The recited processor therefore only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the processor is only recited at a high level of generality as used to perform the data processing function of controlling the signal condition or analysis. The recited processor is therefore not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 7 recites measuring a plurality of parameters of the medical imaging apparatus, wherein the plurality of parameters comprises at least one of: a vibration of a component of the medical imaging apparatus, a vibration of the medical imaging apparatus, an acceleration of a component of the medical imaging apparatus, an acceleration of the medical imaging apparatus, a surrounding temperature of a component of the medical imaging apparatus, a surrounding temperature of the medical imaging apparatus, a surrounding humidity of a component of the medical imaging apparatus, a surrounding humidity of the medical imaging apparatus, a temperature of the medical imaging apparatus, a temperature of a component of the medical imaging apparatus, a mechanical shock of the medical imaging apparatus, a mechanical shock of a component of the medical imaging apparatus, a vacuum parameter of the medical imaging apparatus, an emitter parameter of the medical imaging apparatus, a power supply parameter of the medical imaging apparatus, an over/under voltage parameter of a component of the medical imaging apparatus, an over/under voltage parameter of the medical imaging apparatus, an over/under current parameter of a component of the medical imaging apparatus, an over/under current parameter of the medical imaging apparatus, an X-ray radiation parameter of the medical imaging apparatus, a rotation speed of a component of the medical imaging of the apparatus relative to the medical imaging apparatus, a rotation speed of the medical imaging apparatus, an electron beam parameter of the medical imaging apparatus, and a magnetic field parameter of the medical imaging apparatus. These limitations fall within the scope of the abstract idea as set out above.
Claim 7 recites the additional element of the processor as performing the function of measuring the plurality of parameters.
Page 15 lines 28-35 and page 16 lines 7-11 describe a processing unit in terms of its functions including receiving the measured sensor data, controlling the sensor, storing data, and processing received data. No further description of a particular type or structure of a processing unit is provided. The processor is construed accordingly as encompassing a generic computer processor.
The recited processor therefore only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the processor is only recited at a high level of generality as used to perform the data processing function of the measuring the parameters. The recited processor is therefore not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 8 recites evaluating a plurality of functionalities of the medical imaging apparatus during the different life cycle phases of the medical imaging apparatus. These limitations fall within the scope of the abstract idea as set out above.
Claim 8 recites the additional element of the processor as performing the function of evaluating the plurality of functionalities.
Page 15 lines 28-35 and page 16 lines 7-11 describe a processing unit in terms of its functions including receiving the measured sensor data, controlling the sensor, storing data, and processing received data. No further description of a particular type or structure of a processing unit is provided. The processor is construed accordingly as encompassing a generic computer processor.
The recited processor therefore only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. As stated above, the processor is disclosed as encompassing a generic computer processor and only recited at a high level of generality as performing the data processing function of evaluating the plurality of functionalities. The processor is therefore not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 9 recites the additional elements of a power supply, wherein the monitoring device is configured to be connected to the power supply.
Page 11 lines 22-27 describe the monitoring device as configured for being connected to a self-sustainable power supply or a power supply of the imaging apparatus and further discloses a power supply as “a battery or an accumulator connected to the medical imaging apparatus.” Examiner notes that the term “accumulator” describes an element which collects or accumulates energy, and encompasses devices such as batteries. No further disclosure is provided of the power supply. The power supply is therefore construed as encompassing generic energy storage devices or any other sources of electrical power.
The recited power supply only amounts to mere instructions to implement functions within the abstract idea using computing elements or machines as tools. The power supply is only recited as an element of the monitoring device, and at a high level of generality as connected to the monitoring device. This element is therefore not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 10 recites indicating an optical and/or acoustical signal when the measured parameter of the medical imaging apparatus differ from a predetermined signal signature, wherein the predetermined signal signature depends on the phase of the life cycle. These limitations fall within the scope of the abstract idea as set out above.
Claim 10 recites the additional elements of an indicator as performing the function of indicating the signal.
Page 11 lines 29-31 and page 16 lines 16-17 describe “an indicating unit configured for indicating an optical and/or acoustical signal,” while page 17 stats that “[t]he output 220 may also be any kind of acoustical or optical indicator capable of indicating the result of the evaluation, for instance a display.” The indicator is therefore construed as encompassing generic devices capable of generating sound or light.
The indicator only amounts to mere instructions to implement functions within the abstract idea using computing elements or machines as tools. Specifically, the indicator is only recited at a high level of generality as indicating the optical and/or acoustical signal, which may be construed as any signal capable of being seen or heard, and disclosed as any device capable of performing those functions. The indicator is therefore not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 14 recites evaluating whether an existing functionality of the medical imaging apparatus is maintained, and confirming whether the medical imaging apparatus is capable of providing the functionality; controlling a data acquisition rate of the sensor and/or an analysis of the measured parameter based on the determined life cycle phase of the medical imaging apparatus; measuring a plurality of parameters of the medical imaging apparatus; measuring at least one parameter of the medical imaging apparatus; evaluating a plurality of functionalities of the medical imaging apparatus during the different life cycle phases of the medical imaging apparatus, wherein the different life cycle phases of the medical imaging apparatus comprise least one of: a phase of mounting the medical imaging apparatus, a phase before transporting the medical imaging apparatus, a phase of transporting and storing the medical imaging apparatus, a phase of operating the medical imaging apparatus, and a phase of maintenance of the medical imaging apparatus, and wherein controlling for each phase the at least one sensor based on the parameter to be measured in the respective life cycle phase. These limitations fall within the scope of the abstract idea as set out above.
Claim 14 recites the additional elements of a) the processor of the monitoring device as performing the functions of controlling the data acquisition rate or analysis of the measured parameter and controlling the sensor based on the parameter to be measured, b) the at least one sensor as performing the function of measuring the plurality of parameters, and c) a plurality of sensors as performing the function of measuring the at least one parameter.
Page 7 lines 14-19 describe an acceleration sensor used to measure vibration and acceleration values. Page 10 line 22 – page 23 line 10 describe a plurality of potential parameters measured by the at least one sensor, including acceleration, temperature, humidity, vacuum, voltage, x-ray radiation, rotational speed, and a digital signal of the data processing unit. The sensor or sensors are therefore construed as encompassing generic sensors capable of measuring such parameters.
Page 15 lines 28-35 and page 16 lines 7-11 describe a processing unit in terms of its functions including receiving the measured sensor data, controlling the sensor, storing data, and processing received data. No further description of a particular type or structure of a processing unit is provided. The processor is construed accordingly as encompassing a generic computer processor.
The above elements only amount to mere instructions to implement functions within the abstract idea using computing elements as tools. Particularly, the sensors are only recited at a high level of generality as used to measure the parameters, and the processor is likewise recited at a high level of generality as used to perform data processing functions of controlling the data acquisition rate or parameter analysis. These elements are not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claims 1-10, 13, and 14 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 is indefinite because Examiner is unable to determine the metes and bounds of the claim based on the recitation of the monitoring device “further comprising a power supply, wherein the monitoring device is configured to be connected to the power supply.” Specifically, it is not clear how the monitoring device itself comprises, i.e. itself includes, a power supply, but is then itself “configured to be connected to” the power supply. If the device itself can be connected to the power supply, that implies the power supply is separate from the device, i.e. the device does not comprise the power supply. Examiner requests that Applicant clarify whether the power supply is integral with or separate from the monitoring device.
Claim 14 is indefinite because Examiner is unable to determine the metes and bounds of the claim based on the recitation of “wherein controlling for each phase the at least one sensor based on the parameter to be measured in the respective life cycle phase by the processor of the monitoring device” in lines 18-20. Specifically, the above limitation contains grammatical and structural errors which make the intended scope and meaning unclear. For example, the addition of “wherein” at the beginning of the limitation suggests that the limitation is intended to further limit the function of controlling the at least one sensor for each phase, but no further limitation of this function is actually recited. For purposes of the present examination, the above limitation has been construed as reciting “controlling for each phase the at least one sensor based on the parameter to be measured in the respective life cycle phase by the processor of the monitoring device.” Examiner requests that Applicant clarify the intended scope and language.
Claim Rejections - 35 USC § 103
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.
Claims 1-10, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Choubey et al (US Patent Application Publication 2010/0332245) in view of Powers et al (US Patent Application Publication 2015/0265844).
With respect to claim 1, Choubey discloses the claimed monitoring device for evaluating a functionality of a medical imaging apparatus, the monitoring device comprising:
at least one sensor configured to measure at least one parameter of the medical imaging apparatus during different life cycle phases of the medical imaging apparatus ([5]-[7], [21], [23], and [26]-[27] describe a plurality of sensors measuring various environmental, mechanical, and operational parameters of a medical imaging device; [6], [22], and [53] describe monitoring the sensor parameter data across life cycles including manufacturing, transportation, and use; Figure 5 and [43]-[45] more specifically describe the monitoring of components during transportation and storage);
a processor configured to receive data from the at least one sensor and to analyze the received data (Figure 6 and [46]-[48] describe a processor receiving the data and performing the data processing functions) to evaluate, during at least one life cycle phase of the medical imaging apparatus, whether a functionality of the medical imaging apparatus is maintained ([21], [28], [37], [53], [56], and [60] describe analyzing the data to determine the operational performance, operational state, and need for repair or replacement, i.e. whether their functionality is maintained);
wherein the processor is further configured to determine a present life cycle phase of the medical imaging apparatus ([43]-[45] describe tracking specific types of data during the transportation, storage, and delivery phases, and logging whether the data is outside of acceptable ranges during particular phases; [53] describes tracking the location of components, i.e. a determination of the component being in transit phase or stationary phase; [62] describe sensor data being specifically associated with storage phases or transportation phases, i.e. the system has knowledge of the present phase during the data collection), and to control the at least one sensor ([52] describes controlling parameters of the sensors as well as hardware options such as baud rates, sensing intervales, and others), wherein the functionality of the medical imaging apparatus can be evaluated during an entire life cycle of the medical imaging apparatus, and wherein the entire life cycle comprises the different life cycle phases ([6], [22], and [53] describe the system monitoring the equipment through its phases of transportation, storage, and normal use, i.e. an entire life cycle. Examiner notes that the term “entire life cycle” is not defined in the claim beyond that it “comprises the different life cycle phases”);
but does not expressly disclose:
controlling the at least one sensor based on the determined present life cycle phase of the medical imaging apparatus.
However, Powers teaches that it was old and well known in the art of medical equipment monitoring before the effective filing date of the claimed invention to control at least one sensor based on a determined present life cycle of a medical apparatus ([29]-[31] describe a controller sensing a voltage level of circuitry within a medical device; [18], [19], [33], [35], and [37] describe changing the frequency of testing based on life cycle phase criteria such as number of uses and age of the device, or controlling the sensor to perform a test upon determining that the device is in a use phase based on a user input).
Therefore it would have been obvious to one of ordinary skill in the art of medical equipment monitoring before the effective filing date of the claimed invention to modify the system of Choubey to control at least one sensor based on a determined present life cycle of a medical apparatus as taught by Powers since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Choubey already discloses determining a present life cycle phase as well as controlling a sensor, and controlling a sensor based on the determined life cycle phase as taught by Powers would perform that same function in Choubey, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 2, Choubey/Powers disclose the monitoring device according to claim 1. Choubey further discloses:
evaluating whether an existing functionality of the medical imaging apparatus is maintained, and confirming whether the functionality can be provided ([21], [28], [37], [53], [56], and [60] describe analyzing the data to determine the operational performance, operational state, and need for repair or replacement, i.e. whether a functionality is maintained and whether it can be provided).
With respect to claim 3, Choubey/Powers disclose the monitoring device according to claim 1. Choubey further discloses:
wherein the different life cycle phases of the medical imaging apparatus are at least one of:
a phase of mounting the medical imaging apparatus,
a phase before transporting the medical imaging apparatus ([6] and [22] describe the phases including manufacturing, which occurs before transportation),
a phase of transporting and storing the medical imaging apparatus ([22], [43]-[45], [53], and [62] describe the phases including transportation and storage),
a phase of operating the medical imaging apparatus ([6], [22], [27], and [45] describe the phases including use and operation; [58] provides an example of tracking vibration data of a component for analysis), and
a phase of maintenance of the medical imaging apparatus,
wherein the processor is further configured to control the at least one sensor based on a value of the parameter measured in each respective life cycle phase ([43]-[45] describe controlling the sensors to sense specific types of data, such as environmental temperature which are to be measured during different phases such as transportation, storage, and delivery, while [58] provides an example of tracking vibration data of a component for analysis, i.e. the sensors are controlled to collect the parameter values to be measured during particular phases).
With respect to claim 4, Choubey/Powers disclose the monitoring device according to claim 1. Choubey further discloses: wherein the at least one measured parameter is at least one of:
a vibration of a component of the medical imaging apparatus ([7], [32], and [58] describe tracking vibration of a component),
a vibration of the medical imaging apparatus ([7], [21], [32], and [58] describe tracking vibration of an imaging system),
an acceleration of a component of the medical imaging apparatus,
an acceleration of the medical imaging apparatus,
a surrounding temperature of a component of the medical imaging apparatus ([7] and [43] describe recording environmental temperature),
a surrounding temperature of the medical imaging apparatus ([7], [21], and [43] describe recording environmental temperature for machines),
a surrounding humidity of a component of the medical imaging apparatus ([7] describes recording environmental humidity),
a surrounding humidity of the medical imaging apparatus ([7] and [21] describes recording environmental humidity for machines),
a temperature of the medical imaging apparatus ([23], [26], and [32] describe monitoring temperatures of systems),
a temperature of a component of the medical imaging apparatus ([23], [26], and [32] describe monitoring temperatures of components),
a mechanical shock of the medical imaging apparatus,
a mechanical shock of a component of the medical imaging apparatus,
a vacuum parameter of the medical imaging apparatus,
an emitter parameter of the medical imaging apparatus,
a power supply parameter of the medical imaging apparatus,
an over/under voltage parameter of a component of the medical imaging apparatus,
an over/under voltage parameter of the medical imaging apparatus,
an X-ray radiation parameter of the medical imaging apparatus ([26], [32], [38], and [53] describe the sensors detecting radiation levels of the system),
a rotation speed of a component of the medical imaging of the apparatus relative to the medical imaging apparatus,
a rotation speed of the medical imaging apparatus,
an electron beam parameter of the medical imaging apparatus, and
a magnetic field parameter of the medical imaging apparatus.
With respect to claim 5, Choubey/Powers disclose the monitoring device according to claim 1. Choubey further discloses:
wherein the different life cycle phases of the medical imaging apparatus are determined 1) depending on the measured parameter of the at least one sensor, 2) autonomously by the monitoring device ([43]-[45] describe tracking specific types of data during the transportation, storage, and delivery phases, and logging whether the data is outside of acceptable ranges during particular phases; [53] describes tracking the location of components, i.e. a determination of the component being in transit phase or stationary phase; [62] describe sensor data being specifically associated with storage phases or transportation phases, i.e. the system has knowledge of the present phase during the data collection), or 3) based on an external trigger.
With respect to claim 6, Choubey/Powers disclose the monitoring device according to claim 1. Choubey further discloses:
wherein the processor is configured for controlling a signal condition of the sensor and/or an analysis of the measured parameter based on the determined life cycle phase of the medical imaging apparatus ([45], [48], and [58] describe different analyses performed based on life cycle phases such as transportation or use; [53] states that the analysis is adapted to the data being collected and its purpose).
With respect to claim 7, Choubey/Powers disclose the monitoring device according to claim 1. Choubey further discloses:
wherein the at least one sensor is configured to measure a plurality of parameters of the medical imaging apparatus ([7], [23], [26], and [32] describe the sensors measuring a plurality of different parameters), wherein the plurality of parameters comprises at least one of:
a vibration of a component of the medical imaging apparatus ([7], [32], and [58] describe tracking vibration of a component),
a vibration of the medical imaging apparatus ([7], [21], [32], and [58] describe tracking vibration of an imaging system),
an acceleration of a component of the medical imaging apparatus,
an acceleration of the medical imaging apparatus,
a surrounding temperature of a component of the medical imaging apparatus ([7] and [43] describe recording environmental temperature),
a surrounding temperature of the medical imaging apparatus ([7], [21], and [43] describe recording environmental temperature for machines),
a surrounding humidity of a component of the medical imaging apparatus ([7] describes recording environmental humidity),
a surrounding humidity of the medical imaging apparatus ([7] and [21] describes recording environmental humidity for machines),
a temperature of the medical imaging apparatus ([23], [26], and [32] describe monitoring temperatures of systems),
a temperature of a component of the medical imaging apparatus ([23], [26], and [32] describe monitoring temperatures of components),
a mechanical shock of the medical imaging apparatus,
a mechanical shock of a component of the medical imaging apparatus,
a vacuum parameter of the medical imaging apparatus,
an emitter parameter of the medical imaging apparatus,
a power supply parameter of the medical imaging apparatus,
an over/under voltage parameter of a component of the medical imaging apparatus,
an over/under voltage parameter of the medical imaging apparatus,
an over/under current parameter of a component of the medical imaging apparatus,
an over/under current parameter of the medical imaging apparatus,
an X-ray radiation parameter of the medical imaging apparatus,
a rotation speed of a component of the medical imaging of the apparatus relative to the medical imaging apparatus,
a rotation speed of the medical imaging apparatus,
an electron beam parameter of the medical imaging apparatus, and
a magnetic field parameter of the medical imaging apparatus.
With respect to claim 8, Choubey/Powers disclose the monitoring device according to claim 1. Choubey further discloses:
wherein the processor is further configured to evaluate a plurality of functionalities of the medical imaging apparatus during the different life cycle phases of the medical imaging apparatus ([29] and [32] describe an imaging system as including a variety of subsystems, multiple of which may be equipped with the sensor modules as also provided in [7] and [8]; [21], [28], [37], [53], [56], and [60] describe analyzing the data for particular subsystems to determine the operational performance, operational state, and need for repair or replacement, i.e. whether their functionality is maintained; [6], [22], [27], and [53] describe monitoring the sensor parameter data across life cycles including manufacturing, transportation, and use).
With respect to claim 9, Choubey/Powers disclose the monitoring device according to claim l. Choubey further discloses:
the monitoring device further comprising a power supply, wherein the monitoring device is configured to be connected to the power supply ([9], [23], [46], and [47] describe the system being comprised of computing elements such as microprocessors, computer memory, and analog/digital sensors, all of which inherently require connection to a source of power, i.e. a power supply, to operate).
With respect to claim 10, Choubey/Powers disclose the monitoring device according to claim 1. Choubey further discloses:
further comprising an indicator configured for indicating an optical and/or acoustical signal when the measured parameter of the medical imaging apparatus differ from a predetermined signal signature, wherein the predetermined signal signature depends on the phase of the life cycle ([43]-[45], [54], [58], and [60] describe displaying alerts when a measured parameter deviates from an expected value or trend and where the type of expected value or trend varies based on cycle phase, such as a temperature signature during transport and a vibration signature during use).
With respect to claim 13, Choubey discloses the claimed computer-implemented method for evaluating a functionality of a medical imaging apparatus, the method comprising:
measuring data of at least one parameter of the medical imaging apparatus by at least one sensor during different life cycle phases of the medical imaging apparatus ([5]-[7], [21], [23], and [26]-[27] describe a plurality of sensors measuring various environmental, mechanical, and operational parameters of a medical imaging device; [6], [22], and [53] describe monitoring the sensor parameter data across life cycles including manufacturing, transportation, and use; Figure 5 and [43]-[45] more specifically describe the monitoring of components during transportation and storage);
receiving the measured data from the at least one sensor by a processor (Figure