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 .
Drawings
The drawings filed on February 05, 2025 are accepted.
Claim Objections
Claims 1-18 are objected to because of the following informalities:
Claim 1 recites “an input functions” in line 7 that should be corrected to –input functions--.
Claim 1, lines 16-18: the punctuation that connects the different daily quality control tests should be separated by a comma “,” instead of a semi-colon “;”.
Claim 2 recites “the bypass line and claim 3 recites “the generator bypass line”. They appear to be referring to the same. Consistent claim language is required.
Claim 4, line 4: for the phrase “based on at least in part on the measured amount…”, one of the “on” should be deleted.
For claims 1-18, all the element numbers in the parenthesis should be deleted.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-20 are directed to an “system” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 1, 19 and 20 recites (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: accept patent weight…as an input functions in order to determine the optimal quantity of 82Rb…” and “determine an optimal period of time…, wherein the determination is further based on…”.
In claims 1, 19 and 20, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper. If a person were to receive and evaluate all the input functions, he/she would be able to reasonably determine an optimal quantity of radioactivity dosage (i.e., to “accept…in order to…” as claimed), either based on a look up table, a reference values, or existing data in a database. He or she would further be able to determine an optimal period of time from the commencement of a patient elution to the commencement of an imaging protocol based on the kinetics of the 82Rb, for example, the wash-in and wash-out curves. He or she would be able to determine the optimal period of time by considering other factors including the recited conditions. For the purpose of optimizing a PET imaging scan, one tunes the impact factors together to come up with an imaging protocol that includes the radioactivity dosage, the injection time, the lapse time, etc, and the purpose of the optimization is to perform an adequate PET imaging and to generate PET images that fulfill the requirement of the utility or application that these images are meant for. To accept input functions is no more than a mental step. To determine an optimal period of time is also considered a mental step as there is nothing recited in the claim to suggest an undue level of complexity in how the determination is performed rather than it merely being based on a number of factors. Therefore, a person would be able to perform the accepting and the determination mentally.
Prong Two: Claims 1, 19 and 20 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recites additional steps of (1) a82Sr/82Rb generator; a pump; a processor; a saline reservoir for housing a sterile saline solution; a generator bypass line; and a waste reservoir; and (2) a memory communicatively coupled to the processor.
The step in (1) represent merely system components that are recited to have no link with the above identified abstract idea.
The step in (2) represent merely pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with the use of a processor. “A claim that requires computer may still recite a mental process. MPEP 2106.04(a)(2).III.C.: Performing a mental process on a generic computer, in a computer environment, or using a computer as a tool to perform the steps are considered a mental process”.
As a whole, the additional elements merely recite system components that are either have no link to the abstract idea, or merely serve to gather and feed information to the abstract idea, while generically implementing it in a high level of generality. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and outcome of the abstract idea is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 19 and 20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of (1) a82Sr/82Rb generator; a pump; a processor; a saline reservoir for housing a sterile saline solution; a generator bypass line; and a waste reservoir; and (2) a memory communicatively coupled to the processor. These steps represents system components that are either have no link to the abstract idea, or merely serve to gather and feed information to the abstract idea. For similar reasons set forth in Step 2A, Prong Two above, the additional elements do not provide an inventive concept under Step 2B.
Accordingly, these additional steps amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept. The claims hence are not patent eligible.
Dependent Claims
The dependent claims incorporate all the limitations of their respective independent claims. The following analysis focus on the limitations recited in the dependent claims to determine whether they merely recite further abstract idea, or whether or not they recite additional elements that may either amount to significantly more than the abstract idea in their respective independent claims, or may integrate the abstract idea in their respective independent claims to a practical application.
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons as stated in the analysis for their respective independent claims, hence are patent ineligible:
describing further actions that is recited as no link to the identified abstract idea (claim 2: delivering a saline flush; claim 3: the generator bypass line delivers the saline flush; claim 4: measure an amount of residual radioactivity; claims 6, 10 and 12: measure the total volume of saline; claims 7, 11, 13 and 14: prevent elution until the generator is replaced; claims 8-9: describes an eluant volume standard);
describing further post-activity solution of outputting the outcome of the abstract idea (claim 5: generate an output on a user interface; claims 15 and 16: printer and user interface computer; claim 17: portable cart; and claim 18: further system components);
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Based on the above consideration and analysis, claims 1-20 are patent ineligible, i.e., rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation of “accept patient weight, imaging equipment and acquisition type of the imaging system as an input function in order to determine the optimal quantity of 82Rb to deliver to the patient” in claim 1, line, 6-8 and claims 19-20 is a computer/processor-implemented functional claim limitation as it is directed to processor-executable instructions that, when executed on the processor, caused the system to perform such limitations. Yet the specification does not disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed functions, i.e., how does a processor determine the optimal quantity of 82Rb based on those input functions, in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. The specification merely discloses how those input functions affect the quality of 82Rb in a high generality, such as in [0097] it discloses that “…it is possible to compensate for larger patient size (higher weight) by injecting larger dose of radio activity. At the same time, it is desirable to use the lowest dose necessary to obtain adequate cardiac visualization and individualize the weight-based dose depending on multiple factors…For example, 3D imaging acquisition may require doses at the lower end of the recommended range compared to 2D imaging”. The quantity of Rb, and the time until the scan starts that are determined based on these input factors, as asserted by the Applicant in page 9 of the Remarks filed on September 06, 2024 for the parent applicant US Pat. App. 17/849,372, appear to be critical. Hence, it would be anticipated that the determination would not be as simple as a general trend between the patient size and the dosage, as well as the 3D/2D scans versus a lower/higher dosage. Further, there would not be a simple trend when multiple factors need to be considered. For example, when a 3D scan performed on a larger size patient, vs. a 2D scan performed on a smaller size patient, how does the processor determine the respective “optimal” quantity of the radiotracer and the respective time until commencement of an imaging protocol?
The limitation of “determine an optimal period of time from the commencement of a patient elution to the commencement of an imaging protocol with respect to said patient; wherein the determination is further based on: a total activity dosage to be delivered to the patient during the patient elution; generator performance as determined during a daily quality control test; total system performance as determined during a daily quality control test; wherein the daily quality control tests are constancy check procedure; setup vial in dose calibrator; flush to waste; elution to dose calibrator; continuous activity monitoring; monitor volume through column; or, any combination thereof” in claim 1, lines10-18 and claim 20 is a computer/processor-implemented functional claim limitation as it is directed to processor-executable instructions that, when executed on the processor, caused the system to perform such limitations. Yet the specification does not disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed functions, i.e., how does a processor determine the optimal period of time between the patient elution and the imaging acquisition based on those input functions, in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. In the specification, FIG.11 and the corresponding disclosure in [0086]-[0090] discloses the daily quality check routine. However, there is no further disclosure in regard to how the daily QC is linked to the determination of the delay time between the patient elution and the imaging acquisition. In [0100], the specification discloses the claim language verbatim and does not disclose any details further.
Note that it is not enough either to disclose that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015). As the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, these claims are rejected for lack of written description. For more information regarding the written description requirement, see MPEP §§ 2161, 2162-2163.07(b).
The dependent claims of the above rejected claims are rejected due to their dependency.
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 1-18 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 pre-AIA the applicant regards as the invention.
The indefiniteness issues raised below for claim 1 applies to claims 19 and 20 for the substantially identical limitations recited.
Claim 1, lines 6-9 recites “accept patient weight, imaging equipment and acquisition type of the imaging system as an input functions in order to determine the optimal quantity of 82Rb to deliver to the patient for the production of the diagnostically adequate imaging scan” that renders the scope of the claim indefinite. In the above limitation, the only actively recited action is “accept patient weight, imaging equipment and acquisition type of the imaging system as an input functions”. The rest of limitation is merely an intended use. The next actively recited step of the claim in lines 10-11 is “determine an optimal period of time”. This limitation has no link to the step of accepting, i.e., it is unclear whether the patient weight and the imaging equipment and acquisition type of the imaging system is actually used and how it is used in the determination of the optimal period of time. Further note that in the last wherein clause in lines 19-20, though it recites that the input functions are for optimizing the PET imaging scan, it is unclear of the link between determining an optimal period of time, and the optimization of the PET imaging scan, further the optimization of the PET imaging scan is merely recited as an intended use but not an active action.
Claim 1, line 7 recites “the optimal quantity of 82Rb” and line 8 recites “the diagnostically adequate imaging scan” that render the scope of the claim indefinite. The terms “optimal” and “adequate” are relative terms. They are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 1 recites in lines 8 and 20 the terms “the diagnostically adequate imaging scan”, “the imaging scan” and “the PET imaging scan”. It is unclear whether they refer to the same. Consistent claim language is required. Note that these terms all lack a proper antecedent basis. Please see below for the details.
Claim 1 recites in line 12 “the determination”. It is unclear whether it refers to the determination of the optimal quantity in line 7, or the determination of an optimal period of time in line 10, or both. Clarification with proper amendment is required.
Claim 1 recites in the last line “a system”. It is unclear if it refer to “a positron emission tomography imaging system” recited in line 9 or different systems.
Claim 1 recites in lines 14 and 15 an identical term of “a daily quality control test” that renders the scope indefinite. It is unclear whether they refer to the same. Proper ordinal number or antecedent basis is required.
Claim 1 recites in the last two lines “wherein the patient weight…as an input functions together in a system to optimize the PET imaging scan” that is grammatically incorrect. This wherein clause is missing a verb.
The antecedent basis issues for some of the claims are indicated below.
Applicant is requested to carefully check the entire claim set to ensure that proper antecedent basis is followed throughout the claims:
Claim 1, line 6: “the imaging system” lacks proper antecedent basis
Claim 1, line 7: “ the optimal quantity” lacks proper antecedent basis
Claim 1, line 8: “the production”, “the diagnostically adequate imaging scan”, “the imaging scan” lack proper antecedent basis
Claim 1, line 10: “the commencement of a patient elution” and “the commencement of an imaging protocol” lacks proper antecedent basis
Claim 2, line 3: “the bypass line” lacks proper antecedent basis
Claim 1, line 19: “imaging equipment and acquisition type as an input functions” should be corrected to –the imaging equipment and the acquisition type as the input functions”
Claim 2, line 3: “a patient elution” should be corrected to –the patient elution--.
Claims 6, 10 and 12: “”the total volume of saline” lacks roper antecedent basis.
Claim 6 recites “measure the total volume of saline” in line 3 and “the measured volume” in line 4. It is unclear if they refer to the same. Consistent claim language is required.
Claims 8 and 9 recite “a new patient elution” that renders the scope of the claims indefinite. From the operational point of view, every elution is a new elution. It is unclear what it means by a new patient elution, or whether the term “new” modifies the patient or the elution.
The dependent claims of the above rejected claims are rejected due to their dependency.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-12 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lefort et al., US 2015/0228368 A1, hereinafter Lefort, in view of Dilsizian et al., “ASNC imaging guidelines/SNMMI procedure standard for positron emission tomography (PET) nuclear cardiology procedures”., Journal of Nuclear Cardiology, July 2016, hereinafter Dilsizian.
Claims 1, 2, 19 and 20. Lefort teaches in FIG.3 an 82Sr/82Rb elution system for delivering an elution of 82Rb to a patient ([0030]: a Rubidium (82Rb) elution and control system in which the 82Rb activity rate delivered to a patient can be controlled), comprising:
an 82Sr/82Rb generator (8); a pump (6); a saline reservoir for housing a sterile saline solution (4); a generator bypass line (18) ([0031]: the elution system comprises reservoir 4 of sterile saline solution; a pump 6;… a strontium-rubidium (82Sr/82Rb) generator 8 and a bypass line 18. A controller 28 is connected to the…positron detector 20);
a waste reservoir (26) ([0076]: FIG.9B: a waste collection vessel 26); and
a processor; and a memory communicatively coupled to the processor when the system is operational, the memory bearing processor-executable instructions that, when executed on the processor ([0031]: A controller 28 is connected to the pump, positron detector 20 and valve 16 and 24 to control the elution system 14 in accordance with a desired control algorithm; and [0043]: the user interface 44; and [0070]: the user interface computer (which may comprise a processor and memory), cause the system to
accept patient weight as an input function in order to determine the optimal quantity of 82Rb to deliver to the patient ([0086]: allowing for accurate determination of the amount of injected activity: (2) an injection of the propose amount of activity based on patient size (e.g., as low as 37 MBq for pediatric patients, and as high as 370 MBq for obese patients); and (4) allows for three infusion models – constant flow-rate, constant volume, and constant activity-rate; [0043]: the elution run is designed to generate a target 82Rb activity concentration…In FIG.7, CM(t) is a square-wave function having a predetermined constant activity concentration CM and duration (t2-t1). These parameters may be provided by explicit user input using the user interface 44; FIGS.3 and 7) – amount of activity “based on the patient size” is considered the “patient weight” as claimed, as evidenced by the example of a 10x dose difference for a pediatric patient vs. an obese patient
for the production of a diagnostically adequate imaging scan ([0003]: the sensitivity of 3D PET requires very accurate control of the delivery of 82Rb activity to a patient being assessed; [0036]: at the end of an elution run…ensuring that the patient receives the entire activity dose required for the PET imaging; [0040]: software-based elution system…assists not only system diagnostics, but can also be used to ensure that he elution parameters (e.g., elution concentration and duration) specified for PET imaging have been satisfied) – since 82Rb is used as a radioactive tracer for PET imaging, it would be a common practice in the field of art that, when performing a PET scan, the imaging scan would be anticipated by one in the field of art to be a “diagnostically adequate imaging scan”, wherein
the imaging scan is performed using a positron emission tomography (PET) imaging system ([0004]: 82Rb is used as a positron emission tomography (PET) tracer; and [0039]: each operating mode is described in terms of the associated steps in performing an elution run to support PET imaging of a patient); and
(claim 2 and claim 19) following a patient elution, deliver a saline flush from the reservoir via the bypass line to a location in said system downstream of the generator in order to flush residual 82Rb from the system downstream of the generator and deliver the flushed residual 82Rb to the patient ([0036]: FIG.6b illustrates a “patient line flush” mode of the system, in which the generator and patient valves 16, 24 are positioned to route the saline flow through the bypass line 18 and out through the patient outlet 10…At the end of an elution run, this mode may also be used to flush any 82Rb activity remaining within the patient line 40 into the patient; and [0082]: a flush elution may be performed before performing a patient elution. A flush elution may be considered to be an elution that flushes the system, such as by running inactive saline solution through the system via the bypass line. A patient elution may be considered to be an elution that delivers saline solution containing an active moiety to a patient for medical treatment purposes).
Lefort does not teach that (1) the memory further bears instructions that, when executed on the processor, cause the system to accept the imaging equipment, and acquisition type of the PET imaging system as input functions in order to determine an optimal quantity of Rb to deliver to the patient for the production of the diagnostically adequate imaging scan, wherein the patient weight, imaging equipment and acquisition type as inputs function together in a system to optimize the PET imaging scan; and (2) determine an optimal period of time from the commencement of a patient elution to the commencement of an imaging protocol with respect to said patient, and (3) wherein the determination is further based on: a total activity dosage to be delivered to the patient during the patient elution; generator performance as determined during a daily quality control test; total system performance as determined during a daily quality control test; wherein the daily quality control tests are constancy check procedure; setup vial in dose calibrator; flush to waste; elution to dose calibrator; continuous activity monitoring; monitor volume through column; or, any combination thereof.
In regard to the above feature (1), in an analogous PET imaging scan optimization field of endeavor, Dilsizian teaches that
the memory further bears instructions that, when executed on the processor, cause the system to accept the imaging equipment, and acquisition type of the PET imaging system as input functions in order to determine an optimal quantity of Rb to deliver to the patient for the production of the diagnostically adequate imaging scan (p.3, Col. Left, PET Imaging Systems: 2D or “septa-in” PET scanner, and 3D or “septa-out” scanner…; Col. Right: situation in which 3D mode may be advantageous include the following: …2. Radiation exposure is critical, so that reductions in injected activity are desired...in order to prevent poor-quality images, lower doses are often administered in 3D mode; p.3, Col. Right, ¶-1&2: Many PET/CT manufacturers have opted for scanners that operate only in 3D mode, because these allow maximum patient throughput for multi-bed position oncology studies….Although 3D acquisition is in principle many times more sensitive than 2D, “accidental,” or random coincidences, dead time, and scatter can greatly reduce the effective sensitivity of images acquired in 3D, especially at high doses. Thus, in order to prevent poor-quality images, lower doses are often administered in 3D mode; p.9, Col. Left, ¶-1: 3. 3D imaging requires less dosage than 2D imaging due to the improved sensitivity of the system; and p.2, Col. Left, ¶-1: Positron emitting radionuclide can be produced using a generator (e.g., 82Rb with a 75-second half-like from a 82Sr generator)) – the 2D/3D scanners are considered the “imaging equipment” as claimed, and the 2D/3D mode are considered the “acquisition type of the PET imaging system” as claimed. To prevent poor-quality images is considered to “optimize the PET imaging scan” as claimed.
As Lefort teaches the input function being the patient weight, and Dilsizian teaches the input functions being the imaging equipment and the acquisition type of the imaging system for determining the optimal quantity of 82Rb, when Lefort and Dilsizian are combined, it teaches “the patient weight, imaging equipment and acquisition type as inputs function together in a system to optimize the PET imaging scan” as claimed.
In regard to features (2) and (3), Dilsizian further teaches that
determine an optimal period of time from the commencement of a patient elution to the commencement of an imaging protocol with respect to said patient; wherein the determination is further based on: a total activity dosage to be delivered to the patient during the patient elution; generator performance as determined during a daily quality control test; total system performance as determined during a daily quality control test; wherein the daily quality control tests are constancy check procedure; setup vial in dose calibrator; flush to waste; elution to dose calibrator; continuous activity monitoring; monitor volume through column; or, any combination thereof (p.6, Col. Left: Daily QC scan: each day the PET detectors should be evaluated to ensure proper operation before commencing with patient injections or scans. The daily quality procedure varies according to the design of the scanner and recommendations of the vendor. For example, some scanners use an attenuation blank scan to evaluate detector constancy, and others may use a scan of a standard phantom. In addition to numerical output of the canners, the raw sinogram data also should be inspected to evaluate detector constancy).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system of Lefort employ such a feature of accepting the imaging equipment, and acquisition type of the PET imaging system as input functions in order to determine an optimal quantity of Rb to deliver to the patient for the production of the diagnostically adequate imaging scan and for optimizing the PET imaging scan; and determine an optimal period of time from the commencement of a patient elution to the commencement of an imaging protocol with respect to said patient; wherein the determination is further based on: total system performance as determined during a daily quality control test; wherein the daily quality control tests are constancy check procedure, as taught in Dilsizian for the advantage of “requiring less dosage for 3D imaging due to the improved sensitivity, and to prevent poor-quality images” and “to ensure proper operation of the PET detector with a consistency”, as suggested in Dilsizian, p.9, Col. Left, ¶-1 and p.3, Col. Right, ¶-1&2, and p.6, Col. Left.
The following limitations are considered the intended use of the claimed system: claim 1: “for the production of the diagnostically adequate imaging scan”. This limitation does not further limit the structure of the claimed system, as the PET scanner is not part of the claimed system. There is no recitation in the claim what structural limitation of the system causes the imaging scan production and optimization. As Lefort teaches in [0003] the amount of Rb used as a radiotracer for PET imaging needs to be assessed in order to very accurately control the sensitivity of 3D PET and in [0009] that the radiotracer delivery is controlled to avoid degradation of the image quality, or to obtain the best possible image quality, and Dilsizian teaches in p.3, Col. Right, that radiation exposure is critical,…and …preventing poor-quality images, they are considered reading on the above limitations.
The following limitations are also considered an intended use of the claimed system as they are not actively recited as steps formed by any of the recited system components: claims 1, 19 and 20: “in order to determine the optimal quantity of 82Rb to deliver to the patient for the production of the diagnostically adequate imaging scan”; claim 2: “in order to flush residual 82Rb from the system downstream of the generator and deliver the flushed residual 82Rb to the patient”; claim 10: “in order to assess a remaining volume of saline in the saline reservoir”.
For the above consideration, see MPEP § 2114.II: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim 3. Lefort further teaches
the generator bypass line delivers the saline flush to a feed line that extends between the generator and a positron detector (FIG.9: the bypass line 18 delivers the saline from the saline supply 4 to the feed line 22 that is in between the generator 8 and the detector 20).
Claim 4. Lefort further teaches
following a patient elution ([0036]: FIG.6b illustrates a “patient line flush” mode of the system 14…At the end of an elution run, this mode may also be used to flush any 82Rb activity remaining within the patient line 40 into the patient),
to measure an amount of residual radioactivity in the system downstream of the generator, and based on at least in part on the measured amount of residual activity, determine a volume of the saline flush for flushing at least some of the residual radioactivity from the system downstream of the generator ([0042]: the controller 28 implements a threshold-based control algorithm, in which the generator valve 16 is controlled by comparison of measured activity concentration to a desired activity concentration. If the measured concentration is higher than the desired concentration, the generator valve 16 directs saline flow to the bypass line 18).
Claim 6. Lefort further teaches
measure the total volume of saline that flows through the generator during the total period of use of that generator, and use the measured volume to assess a remaining lifetime of the generator ([0060]: One way of obtaining the generator performance data is to calibrate the elution system 14 by performing a predefined elution run with the patient outlet 10 connected to a conventional dose calibrator. Such a calibration elution run enables the dose calibrator to be used to measure the generator performance in terms of, for example, 82Rb activity concentration vs. eluted volume. This data can be used to predict eluted 82Rb activity concentration, for any given saline flow rate, with an accuracy that that will gradually decline with time elapsed since the calibration run. Repeating the calibration run at regular intervals (e.g. once per day) allow the generator performance data to be updated to track changes in the generator performance as the generator ages) – the eluted volume for any given saline flow rate that is used to predict the radioactivity in order to assess the performance of the generator at the above cited calibration step is considered the “total volume of saline” measured as claimed.
Claim 7. Lefort further teaches that
prevent elution until the generator is replaced with a new generator when an assessed remaining lifetime of the generator is inadequate to meet a preset standard ([0086]: Data may then be retrieved by the generator manufacturer, and in-use generator performance may be determined. This allows for daily monitoring of generator and infuser performance and for preventative intervention before patients are affected. Constant feedback may be sent from the computer to the peristaltic pump. If the user interface fails to operate, the peristaltic pump may be shut down to prevent risk to a patient; [0060]: repeating the calibration run at regular intervals allows the generator performance data to be updated to track changes in the generator performance as the generator ages; and [0063]: the predictive control algorithm uses stored generator performance data to predict a value duty cycle that will yield the target activity concentration at the positron detector…This functionality is useful for ensuring accuracy of the predictive control algorithm, as well as compensating valve performance changes due, for example, to component aging and wear).
Although Lefort does not explicitly teach that the present standard for replacing a new generator is when an assessed remaining lifetime of the generator is inadequate to meet an amount of time from manufacture, i.e., the age of the generator, Lefort teaches means for tracking and predict the performance of the generator as it ages. Since the generator is a component that wears and ages, it would be obvious to one of ordinary skill in the art that when the generator ages to a certain degree, i.e., passing a particular time from manufacture, and is not capable of deliver the required performance, i.e., does not pass the calibration of [0060] or is predicted to fail using the predictive control algorithm of [0063], such an aging condition would cause the system to prevent elution as the generator can no longer perform properly. The generator would need to be replaced in order for the system to function properly, i.e., the elution would not be resumed until a new generator is replaced.
To set the present standard to be an amount of time from manufacture as claimed is an obvious common practice that requires only a common knowledge of one of ordinary skill in the art for the reason of “ensuring system accuracy and limiting the potential for human error, as suggested in Lefort, [0060].
Claim 8. Lefort further teaches that
the preset standard is a volume of eluant required for a patient elution (claim 1: begin to assess…the volume of the fluid that is eluted from the generator; and claim 3: in response to determining that a total volume of the fluid eluted exceeds a limit threshold, preventing elution until the generator is replaced with a new generator).
Claim 9. Lefort further teaches that
the preset standard is an amount radioactivity required for a new patient elution (claim 1: begin to assess a concentration of 82Rb, 82Sr, or 85Sr in a fluid that is eluted from the generator; and claim 4: in response to determining that a ratio of 82Sr to 82Rb, or 85Sr to 82Rb is greater than a maximum threshold of USP, preventing elution until the generator is replaced with a new generator).
Claim 10. Lefort further teaches
measure the total volume of saline that flows through the generator and through the bypass line during the total period of use of the saline reservoir ([0060]: One way of obtaining the generator performance data is to calibrate the elution system 14 by performing a predefined elution run with the patient outlet 10 connected to a conventional dose calibrator. Such a calibration elution run enables the dose calibrator to be used to measure the generator performance in terms of, for example, 82Rb activity concentration vs. eluted volume; and [0048]: in the “elution” mode of operation (FIG.6d), the generator valve 16 is actively controlled via a control loop from the position detector 20 to proportion saline flow though both the generator 8 and the bypass line 18. Recombining the corresponding generator and bypass saline flows downstream of the generator produces an active saline solution) – the active saline solution, which is the eluted saline volume recombined from the generator flow and the bypass saline flow, is the “total volume of saline” as claimed.
in order to assess a remaining volume of saline in the saline reservoir – to subtract the volume of the active saline solution (i.e., the total volume of saline” as claimed) from the starting volume of saline in the saline reservoir (the saline supply of the cited Lefort) would result in the remaining volume of saline in the saline reservoir. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to obtain such a remaining volume through routine experimentation that would be a straightforward mathematical operation with reasonable expectation of success.
Claim 11. Lefort further teaches
cause the system to prevent elution until the saline reservoir is refilled with saline or replaced with a new saline reservoir when the assessed remaining volume of saline in the saline reservoir is less than a preset volume ([0009]: a limitation of this approach, particularly for 3D PET imaging, is that the delivery of a high activity rate over a short period of time tends to degrade imaging quality. Low activity rates supplied over a relatively extended period are preferred. As a result, the user is required to estimate the saline flow rate that will obtain the best possible image quality; and [0064]: during each elution run, desired flow ratios can be calculated (e.g., based on the saline flow rate…etc) and error function values stored as a function of desired flow ratio; [0082]: a patient elution may be considered to be an elution that delivers saline solution containing an active moiety to a patient for medical treatment purposes. Alternatively, where 82Sr or 85Sr concentration is above a threshold, embodiments of the invention may prevent a patient elution from being performed until a flush elution and a successful calibration elution have been performed) – The patient elution is a mix of the radioactivity material and the saline solution. When the concentration of the radioactivity is above a threshold, i.e., too high, the elution is prevented until there is sufficient flush elution (such that the concentration of the patient elution can be brought down to a proper level). Hence, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform means for replenishing the flush elution, i.e., the saline solution. One of ordinary skill in the art would be able to perform so either by refilling the saline supply, or by replacing the saline supply with a filled one. Further, to set a threshold for the saline supply to be refilled or replaced is considered a commonly-acknowledged way to set a condition, in this case, for ensuring that the components are operated safely and properly. The threshold may be set by the user to be any appropriate value based on the objective of the imaging data processing.
Claim 12. In regard to the claimed feature of receiving a volume of saline that is eluted from the generator, measuring the total volume of saline received by the waste reservoir during the total period of use of that waste reservoir, and using the measured volume to assess the volume of saline in the waste reservoir relative to the total volume capacity of the waste reservoir, it requires only routine skills to one of ordinary skill in the art to measure volumes of a solution in different containers. Further to assess one volume relative to another requires only basic mathematical skill, or even by a visual comparison. It would have been obvious for one of ordinary skill in the art would be able to perform the claimed feature before the effective filing date of the claimed invention through routine experimentation with reasonable expectation of success.
Claim 14. Lefort further teaches
cause the system to prevent elution until the saline reservoir is refilled with saline or replaced with a new saline reservoir when the assessed remaining volume of saline in the saline reservoir (4) is less than a preset volume ([0009]: a limitation of this approach, particularly for 3D PET imaging, is that the delivery of a high activity rate over a short period of time tends to degrade imaging quality. Low activity rates supplied over a relatively extended period are preferred. As a result, the user is required to estimate the saline flow rate that will obtain the best possible image quality; and [0064]: during each elution run, desired flow ratios can be calculated (e.g., based on the saline flow rate…etc) and error function values stored as a function of desired flow ratio; [0082]: a patient elution may be considered to be an elution that delivers saline solution containing an active moiety to a patient for medical treatment purposes. Alternatively, where 82Sr or 85Sr concentration is above a threshold, embodiments of the invention may prevent a patient elution from being performed until a flush elution and a successful calibration elution have been performed) – The patient elution is a mix of the radioactivity material and the saline solution. When the concentration of the radioactivity is above a threshold, i.e., too high, the elution is prevented until there is sufficient flush elution (such that the concentration of the patient elution can be brought down to a proper level). Hence, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform means for replenishing the flush elution, i.e., the saline solution. One of ordinary skill in the art would be able to perform so either by refilling the saline supply, or by replacing the saline supply with a filled one. Further, to set a threshold for the saline supply to be refilled or replaced is considered a commonly-acknowledged way to set a condition, in this case, for ensuring that the components are operated safely and properly. The threshold may be set by the user to be any appropriate value based on the objective of the imaging data processing..
Claim 15. Lefort further teaches
in FIG.9A a printer (50), and in FIG.9C a user interface computer (44) ([0075]: FIG.9A depicts the printer 50…FIG.9C depicts a user interface 44).
Claim 16. Lefort further teaches that
the user interface computer (44) is configured to communicate with a remote computer, selected from the group consisting of a server, a cloud computing service or combinations thereof ([0073]: the user interface computer may be configured to communicate with a remote computer, such as a server, or a cloud computing server).
Claim 17. Lefort further teaches in FIGS.9A-9C that
the system is embodied in a portable cart (68) that houses the generator (8), the processor, the pump (6), the memory, the patient line (40), the bypass line (18), the positron detector (20), and the dose calibrator; and wherein the portable cart (68) comprises an interior that is coated with a vibration-absorbing material ([0075]: the system embodied in such a portable cart 68. The cart 68 itself can comprise an interior 70 that is coated with a vibration-absorbing material).
Claim 18. Lefort further teaches in FIG.9
a patient line (40), a waste collection vessel (26), a waste line (60), a pressure sensor (62), a Y-junction (64) into which saline may flow, a flow regulator (66) on the bypass line (18), a generator line (5), and a peristaltic pump (6).
Claims 5 are rejected under 35 U.S.C. 103 as being unpatentable over Lefort et al., US 2015/0228368 A1, hereinafter Lefort, in view of Dilsizian et al., “ASNC imaging guidelines/SNMMI procedure standard for positron emission tomography (PET) nuclear cardiology procedures”., Journal of Nuclear Cardiology, July 2016, hereinafter Dilsizian, further in view of Klein et al., “Intra- and inter-operator repeatability of myocardial blood flow and myocardial flow reserve measurements using rubidium-82 pet and a highly automated analysis program”. J. Nuclear Cardiology. 2010, Vol.17, No. 4;600-16, hereinafter Klein.
Claim 5. Lefort and Dilsizian combined teaches all the limitations of claim 1.
Neither Lefort nor Dilsizian teaches “generate an output on a user interface of the determined optimal period of time until commencement of the imaging protocol”.
However, in an analogous automated PET scan system field of endeavor, Klein teaches
generate an output on a user interface of the determined optimal period of time until commencement of the imaging protocol (p.601, Col. Right, Image Acquisition: Scan were acquired according to our standard clinical protocol (FIGURE 1). In Figure 1, both the rest scan and stress scan protocols show a PET scan acquisition is 30 second after the 82Rb infusion; and p.602, Col. Right, ¶-4: the graphical report (FIG.3C) displays the results of the optimization process, which also enabled the operator to intervene at each stage if necessary by manual adjustment of the fitted ellipses).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system of Lefort employ such a feature of generate an output on a user interface of the determined optimal period of time until commencement of the imaging protocol as taught in Klein for “enable the operator to intervene if necessary” for “ensuring accurate measurement of the bolus first-pass activity”, as suggested in Klein, p.601, Col. Right, Image Acquisition; and p.602, Col. Right, ¶-4.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lefort, in view of Dilsizian, as applied to claim 12, further in view of Hidem et al., US 2009/0312630 A1, hereinafter Hidem.
Claim 13. Lefort and Dilsizian combined teaches all the limitations of claim 1.
Neither Lefort nor Dilsizian teaches that the system is caused to prevent elution until the waste reservoir is emptied when an assessed volume of saline in the waste reservoir is greater than a safe volume for preventing overflow of the waste reservoir.
However, in an analogous 82Sr generator safety and maintenance field of endeavor, Hidem teaches
prevent elution until the waste reservoir is emptied when an assessed volume of saline in the waste reservoir is greater than a safe volume for preventing overflow of the waste reservoir ([0054]: the computer can track the filling of waste bottle via monitoring of the operation of pump and divergence valve, and provide an indication to the user when waste bottle needs to be emptied…System 10 automatically precludes any further operation of the system until the waste bottle is emptied).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system of Lefort and Dilsizian combined employ such a feature of prevent elution until the waste reservoir is emptied when an assessed volume of saline in the waste reservoir is greater than a safe volume for preventing overflow of the waste reservoir as taught in Hidem for the advantage of providing a routine maintenance of the system to avoid an overflow of the waste bottle, as suggested in Hidem, [0054].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal M Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YI-SHAN YANG/Primary Examiner, Art Unit 3798