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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 MARCH 2026 has been entered.
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 – 4, and 6 – 21 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.
Claim 1 (lines 24 – 26), Claim 8 (lines 25 - 27), and Claim 9 (lines 19 - 21) each recite the limitation “optimizing aortic valve replacement selection by selecting patients to undergo valve replacement when the predicted outcome for an aortic valve replacement procedure is positive, as generated by the system based on the first vascular impedance value”. Looking to [Page 6, Lines 7 – 8], it is disclosed that “For example, the recommendation may be that the patient should or should not undergo an aortic valve replacement procedure at this time.” This does not particularly disclose that an optimization is occurring, nor that a the patients that are selected actually undergo the surgery. There is no description of the steps or hardware necessary for the processor itself to both “optimize” and potentially perform valve replacement surgery on selected patients. It is not specified if these elements are particular algorithms, if they are performed by a software or hardware component of the “one or more processors”, if the instant device itself performs aortic valve replacement surgery. Therefore, adequate disclosure is needed. Claims 2 – 4, 6 – 7, and 10 – 21 are similarly rejected due to their dependence on Claims 1, 8, and 9.
Claim 1 (line 27) recites the term “scheduling a selected patient for the valve replacement”. There is no disclosure of any scheduling mechanism in the instant specification. It is not specified if the scheduling is performed by an algorithm relative to a calendar, if the scheduling is performed by a software or hardware component of the “one or more processors”, or how the scheduling positively occurs. Therefore, adequate disclosure is needed. Claims 2 – 4, 6 – 7, and 10 – 21 are similarly rejected due to their dependence on Claims 1, 8, and 9.
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 – 4, and 6 – 21 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 1 (lines 1 - 3) and Claim 8 (lines 1 - 3) each recite in their preamble “A patient-specific computational modeling system for optimizing aortic valve replacement selection and predicting an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance”. As recited, it is unclear if this “aortic valve replacement selection” is intended to refer to the surgical selection of the replacement aortic valve itself that is going to go into a particular patient (as in optimizing sizing of the valve through iterative geometric calculations, cross-referencing valve manufacturers to optimize cost, etc.). Alternatively, this is intended to recite potential applications for which “determining vascular impedance” could be useful, in which case having a computational modeling system than determines vascular impedance would satisfy both “optimizing’ and “predicting”. There is no particular disclosure of optimization procedures or algorithms performed by the system in the Applicant’s specification. For the purposes of examination, the term “A patient-specific computational modeling system for optimizing aortic valve replacement selection and predicting an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance” is deemed to claim “A computational modeling system for predicting an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance.” Claims 2 – 4, 6 – 7, and 16 – 21 are similarly rejected due to their dependence on Claims 1 and 8.
Claim 1 (line 24) and Claim 8 (line 25) each recite the limitation “optimizing aortic valve replacement selection”. It is unclear if this is intended to be the same or different than the aortic valve replacement selection previously recited in the preamble of the claim. For the purposes of examination, the term “optimizing aortic valve replacement selection” is deemed to claim “optimizing the aortic valve replacement selection”. Claims 2 – 4, 6 – 7, and 16 – 21 are similarly rejected due to their dependence on Claims 1 and 8.
Claim 1 (line 26), Claim 8 (line 27 - 28), and Claim 9 (line 20 - 21) each recite the limitation “the predicted outcome for an aortic valve replacement procedure”. It is unclear if this is intended to be the same or different than the previously-recited aortic valve replacement procedure. For the purposes of examination, the term “the predicted outcome for an aortic valve replacement procedure” is deemed to claim “the predicted outcome for the aortic valve replacement procedure”. Claims 2 – 4, 6 – 7, and 10 – 21 are similarly rejected due to their dependence on Claims 1, 8, and 9.
Claim 1 (lines 24 – 26), Claim 8 (lines 25 - 27), and Claim 9 (lines 19 - 21) each recite the limitation “optimizing aortic valve replacement selection by selecting patients to undergo valve replacement when the predicted outcome for an aortic valve replacement procedure is positive, as generated by the system based on the first vascular impedance value”. It is unclear if the “patients” being selected are intended to be the same or different than the previously-recited “the patient”. It is additionally unclear if the intent is that the device itself performs a valve replacement surgery, if the surgery has to occur in order to meet the metes and bounds of the claim, and if the optimization is for selecting valve sizes, etc., for the surgery, or if the intent is that a recommendation that the surgery would be potentially beneficial to the patient. For the purposes of examination, the term “optimizing aortic valve replacement selection by selecting patients to undergo valve replacement when the predicted outcome for an aortic valve replacement procedure is positive, as generated by the system based on the first vascular impedance value” is deemed to claim “classifying the patient as eligible for valve replacement when the predicted outcome for an aortic valve replacement procedure is positive, as generated by the system based on the first vascular impedance value”. Claims 2 – 7 and 10 – 20 are similarly rejected due to their dependence on Claims 1, 8, and 9, respectively.
Claim 1 (line 19) and Claim 8 (line 20) each recite the term “has a vascular impedance”. It is unclear if this is intended to be the same or different than the previously-recited vascular impedance recited in the preamble of the claims. For the purposes of examination, the term “has a vascular impedance” is deemed to claim “has the vascular impedance”. Claims 2 – 4, 6 – 7, and 16 – 21 are similarly rejected due to their dependence on Claims 1 and 8.
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 – 4 and 6 - 21 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.
Regarding Claims 1, 8, and 9, the claims recite an apparatus, which is one of the statutory categories of invention (Step 1). The claims are then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 1 – 4 and 6 - 21 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 – 4 and 6 - 21 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1 – 4 and 6 - 21 recites an abstract idea.
Specifically, Claims 1 – 4 and 6 - 21 recite (underlined are observations, judgments, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 1
A patient-specific computational modeling system for optimizing aortic valve replacement selection and predicting an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance, the system configured to execute operations comprising:
receiving, by one or more computer processors coupled to memory, data associated with a patient, the data comprising a heart rate value, a peak velocity through aortic valve value, and a stroke volume value;
generating a flow waveform for the patient using the data;
determining a set of candidate vascular impedance values for the patient based at least in part on the flow waveform, the set of candidate vascular impedance values comprising a first vascular impedance value and a second vascular impedance value;
determining a first pressure waveform using the flow waveform and the first vascular impedance value;
determining a second pressure waveform using the flow waveform and the second vascular impedance value;
receiving a blood pressure value for the patient;
determining that the first pressure waveform is a closer match to the blood pressure value than the second pressure waveform;
determining that the patient has a vascular impedance of the first vascular impedance value;
generating, by the one or more computer processors, a predicted outcome of an aortic valve replacement procedure for the patient based at least in part on the first vascular impedance value, and
optimizing aortic valve replacement selection by selecting patients to undergo valve replacement when the predicted outcome for an aortic valve replacement procedure is positive, as generated by the system based on the first vascular impedance value; and
scheduling a selected patient for the valve replacement.
Claim 8:
A patient-specific computational modeling system for optimizing aortic valve replacement selection and predicting an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance, the system configured to execute operations comprising:
determining, by one or more computer processors coupled to memory, echocardiographic data associated with the patient, the echocardiographic data comprising a heart rate value, a peak velocity through aortic valve value, an aortic valve area value, and a stroke volume value;
generating a flow waveform for the patient using the echocardiographic data; determining a set of candidate vascular impedance values for the patient based at least in part on the flow waveform, the set of candidate vascular impedance values comprising a first vascular impedance value and a second vascular impedance value; determining a first pressure waveform using the flow waveform and the first vascular impedance value; determining a second pressure waveform using the flow waveform and the second vascular impedance value; determining a blood pressure value for the patient; determining that the first pressure waveform is a closer match to the blood pressure value than the second pressure waveform; determining that the patient has a vascular impedance of the first vascular impedance value, and then
using the vascular impedance to determine whether the patient is a suitable candidate for an aortic valve replacement procedure.
generating a predicted outcome of an aortic valve replacement procedure for the patient based at least in part on the first vascular impedance value, and optimizing aortic valve replacement selection by selecting patients to undergo valve replacement when the predicted outcome for an aortic valve replacement procedure is positive, as generated by the system based on the first vascular impedance value.
Claim 9:
A device comprising: memory configured to store computer-executable instructions; and at least one computer processor configured to access the memory and execute the computer-executable instructions to: determine data associated with a patient, the data comprising a heart rate value, a peak velocity through aortic valve value, and a stroke volume value; generate a flow waveform for the patient using the data; determine a set of candidate vascular impedance values for the patient based at least in part on the flow waveform, the set of candidate vascular impedance values comprising a first vascular impedance value and a second vascular impedance value; determine a blood pressure value for the patient; determine that a first pressure waveform is a closer match to the blood pressure value than a second pressure waveform; determine that the patient has a vascular impedance of the first vascular impedance value; generate a predicted outcome of an aortic valve replacement procedure for the patient based at least in part on the first vascular impedance value, and optimizing aortic valve replacement selection by selecting patients to undergo valve replacement when the predicted outcome for an aortic valve replacement procedure is positive, as generated by the system based on the first vascular impedance value;
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 1, 8, and 9, these limitations include:
Observation and judgment to optimize aortic valve replacement selection
Observation and judgment to predict an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance
Observation and judgment of data associated with a patient, or echocardiographic data associated with a patient the data comprising a heart rate value, a peak velocity through aortic valve value, and a stroke volume value;
evaluation of a flow waveform for the patient using the data, or the echocardiographic data
observation and judgment of a set of candidate vascular impedance values for the patient based at least in part on the flow waveform, the set of candidate vascular impedance values comprising a first vascular impedance value and a second vascular impedance value;
evaluation of a first pressure waveform using the flow waveform and the first vascular impedance value;
evaluation of a second pressure waveform using the flow waveform and the second vascular impedance value;
observation and judgment of a blood pressure value for the patient;
observation and judgment that the first pressure waveform is a closer match to the blood pressure value than the second pressure waveform;
observation and judgment that the patient has a vascular impedance of the first vascular impedance value.
using the vascular impedance to make observation and judgment whether the patient is a suitable candidate for an aortic valve replacement procedure
observation and judgment of a predicted outcome of an aortic valve replacement procedure for the patient based at least in part on the first vascular impedance value.
observation and judgment to optimize aortic valve replacement selection by selecting patients to undergo valve replacement when the predicted outcome for an aortic valve replacement procedure is positive, based on the first vascular impedance value
Certain methods of direction human activity:
observation and judgment to schedule a selected patient for the valve replacement.
all of which are grouped as mental processes or certain methods of organizing human activity under the 2019 PEG.
Similarly, Dependent Claims 2 – 4, 6 – 7, and 10 - 21 include the following abstract limitations, in addition the aforementioned limitations in Independent Claims 1, 8 and 9 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
generating a recommendation for an aortic valve replacement procedure for the patient based at least in part on the vascular impedance
observation and judgment for communicating a recommendation for an aortic valve replacement procedure for the patient based at least in part on the vascular impedance
determining the first pressure waveform based at least in part on a Fourier Transform of the flow waveform and the first vascular impedance value.
Evaluation to determine the first pressure waveform based at least in part on a Fourier Transform of the flow waveform and the first vascular impedance value.
filter out the second pressure waveform based at least in part on one or more domain bounding criteria.
observation and judgment to filter out the second pressure waveform based at least in part on one or more domain bounding criteria.
determine the vascular impedance of a patient
follow a series of steps to make observation and judgment of the vascular impedance of a patient
all of which are grouped as mental processes under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claims 1, 8 and 9 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Independent Claims 1, 8 and 9), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
one or more computer processors
memory
computer processor
echocardiographic device
ultrasound device
oscillometric device
Additional elements recited include an “one or more computer processors” to determine; “memory” to store; and “computer processor” to access, and execute in the Independent Claims 1, 8 and 9 and their dependent claims. These component are recited at a high level of generality, , i.e., as a generic computer processor performing a generic function of processing data (the determining, accessing, and executing) and a memory performing a generic function of storing data (the storing). These generic hardware component limitations for “one or more computer processors”, “memory”, “computer processor”, “echocardiographic device”, “ultrasound device”, and “oscillometric device” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claims 1, 8 and 9 include pre-solution activity limitations, such as:
receiving, by one or more computer processors coupled to memory, data associated with a patient, the data comprising a heart rate value, a peak velocity through aortic valve value, and a stroke volume value;
receiving a blood pressure value for the patient;
the echocardiographic data comprising a heart rate value, a peak velocity through aortic valve value, an aortic valve area value, and a stroke volume value;
memory configured to store computer-executable instructions;
at least one computer processor configured to access the memory and execute the computer-executable instructions to
In addition the aforementioned extra-solution activity limitations in Independent Claims 1, 8 and 9, additional extra-solution activity limitations recited in Dependent Claims 2 – 4, 6 – 7, and 10 – 20 include:
the one or more domain bounding criteria comprise pressure waveform upstroke (positive value), ejection duration range, and diastolic decay
wherein the data further comprises an aortic valve area value.
wherein the data is echocardiographic data.
wherein the data is MRI data
wherein the data associated with the patient is received from at least one of an echocardiographic device or an ultrasound device, and the blood pressure value is received from an oscillometric device
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “one or more computer processors”, “memory”, “computer processor”, “echocardiographic device”, “ultrasound device”, and “oscillometric device” as recited in Independent Claims 1, 8 and 9 and their dependent claims are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claims 1, 8 and 9 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claims 1, 8 and 9 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 1, 8 and 9 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 – 4 and 6 - 21 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “one or more computer processors”, “memory”, “computer processor”, “echocardiographic device”, “ultrasound device”, and “oscillometric device” as recited in Independent Claims 1, 8 and 9 and their dependent claims.
The additional elements of the “one or more computer processors”, “memory”, “computer processor”, “echocardiographic device”, “ultrasound device”, and “oscillometric device” in Claims 1 – 4 and 6 – 21, as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “one or more computer processors” and “computer processor” is described generically at [Page 11, Lines 20 - 32], including “The processor(s) 602 may include any suitable processing unit capable of accepting data as input, processing the input data in accordance with stored computer-executable instructions…” and lists numerous examples of generic processor types. The processor is presented as box element “Processor(s)” 602 in Figure 3.
Per Applicant’s specification, the “memory” is described generically In [Page 9, Lines 30 - 34] – [Page 10, Lines 1 – 12], as ..”In various implementations, the memory 604 may include multiple different types of memory such as various types of static random access memory (SRAM), various types of dynamic random access memory (DRAM), various types of unalterable ROM, and/or writeable variants of ROM such as electrically erasable programmable read-only memory (EEPROM), flash memory, and so forth.” The memory is presented as box element “memory device(s)” 604 in Figure 3.
Per Applicant’s specification, the “echocardiographic device” is described generically in [Page 7, Top] “…the device may be…integrated into, or operatively in communication with, conventional medical equipment, such as an echocardiograph (ECG) machine”. The “echocardiographic device” is not shown specifically in a figure. There is a broad “Sensor(s)/Sensor Interfaces(s)” block in Figure 3.
Per Applicant’s specification, the “ultrasound device” is described generically in [Page 7, Paragraph 4] “The system may include an echocardiography ultrasound machine, as known in the art.” The “ultrasound device” is not shown specifically in a figure. There is a broad “Sensor(s)/Sensor Interfaces(s)” block in Figure 3.
Per Applicant’s specification, the “oscillometric device” is described generically in [Page 7, Top] “…the device may be…integrated into, or operatively in communication with, conventional medical equipment, such as…manual or digital blood pressure measurement monitors or sphygmomanometers”. The “oscillometric device” is not shown specifically in a figure. There is a broad “Sensor(s)/Sensor Interfaces(s)” block in Figure 3.
Accordingly, in light of Applicant’s specification, the claimed terms “one or more computer processors”, “memory”, “computer processor”, “echocardiographic device”, “ultrasound device”, and “oscillometric device” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “one or more computer processors”, “memory”, “computer processor”, “echocardiographic device”, “ultrasound device”, and “oscillometric device”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1 – 4 and 6 - 21 amounts to mere instructions to implement the abstract idea on a computer. Simply using 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 provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatuses of Claims 1 – 4 and 6 - 21 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1 – 4 and 6 - 21 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Independent Claims 1, 8 and 9 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1 – 4 and 6 - 21 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1 – 4 and 6 - 21 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 – 4 and 6 - 21 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 2, 4, 6 – 7, 17 – 18, and 20 - 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Assa et. al., (“Ventricular stroke work and vascular impedance refine the characterization of patients with aortic stenosis”) in view of Hachicha, et. al., (“Usefulness of the Valvuloarterial Impedance to Predict Adverse Outcome in Asymptomatic Aortic Stenosis”), further in view of HeartValveSurgery.com (“Webinar Transcript Timing Heart Valve Surgery”).
Regarding Claim 1, Ben-Assa discloses A patient-specific computational modeling system ([Abstract])(See 112b interpretation above as “A computational modeling system for predicting an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance.”), the system configured to execute operations ([Abstract]; [Page 3, Paragraph 2], “We applied advanced computational models”) comprising:
determining a first pressure waveform using the flow waveform and the first vascular impedance value ([Page 14, Fig 1] “…the SphygmoCor XCEL device, used to derive peripheral (brachial) and central (aortic) pressure waveforms; ([Page 21, Table 3] “Vascular impedance (Z0) Baseline”; ([Page 14, Paragraph 1] “The aortic input impedance spectrum was derived using Fourier decomposition of the noninvasive central pressure and LVOT velocity waveforms; ([Page 3, Paragraph 2], “We applied advanced computational models to calculate… vascular impedance in patients before and after TAVR”)(Examiner notes that the waveforms were calculated before and after TAVR, thereby using the first and second waveform and impedance information. The first waveform and first impedance are associated with the patient prior to the TAVR procedure.).
determining a second pressure waveform using the flow waveform and the second vascular impedance value ([Page 14, Fig 1] “…the SphygmoCor XCEL device, used to derive peripheral (brachial) and central (aortic) pressure waveforms; ([Page 21, Table 3] “Vascular impedance (Z0) 30 days post TAVR”; ([Page 14, Paragraph 1] “The aortic input impedance spectrum was derived using Fourier decomposition of the noninvasive central pressure and LVOT velocity waveforms; ([Page 3, Paragraph 2], “We applied advanced computational models to calculate… vascular impedance in patients before and after TAVR”)(Examiner again notes that the waveforms were calculated before and after TAVR, thereby using the first and second waveform and impedance information. The second waveform and second impedance are associated with the patient after the TAVR procedure.).
receiving (or determine for Claim 9), by one or more computer processors coupled to memory ([Page 8, Vascular impedance calculation Section, All of Paragraph 1] including “SphygmoCor” and “via an in-house MATLAB program.”)(Examiner notes that MATLAB is a computer application that is used with a computer’s processors and is capable of receiving information and saving files to memory), data associated with a patient ([Page 22] Table 4), the data comprising a heart rate value ([Page 22] Table 4, “Heart rate, bpm”), a peak velocity through aortic valve value ([Page 22] Table 4, “Peak velocity, cm/sec”), and a stroke volume value ([Page 22] Table 4, “Stroke volume Index, ml/m^2);
generating a flow waveform ([Page 8, Vascular impedance calculation Section, Paragraph 1] “…a velocity tracing”; [Page 14, Fig 1] “central velocity waveforms”) for the patient using the data ([Page 8, Vascular impedance calculation Section, Paragraph 1] “…a velocity tracing from pulsed wave Doppler measured in the LVOT”; [Page 14, Fig 1] “Valvular: Echocardiographic pulse wave Doppler tracings captured at the left ventricular outflow tract (LVOT), used to derive central velocity waveforms”)
determining a set of candidate vascular impedance values ([Page 14, Paragraph 1] “aortic input impedance spectrum”) for the patient based at least in part on the flow waveform ([Page 14, Paragraph 1] “The aortic input impedance spectrum was derived using Fourier decomposition of the noninvasive central pressure and LVOT velocity waveforms. Z0 is the impedance modulus at the zero harmonic. Characteristic impedance (Zc) was calculated as the average of frequencies 2–10 Hz.”), the set of candidate vascular impedance values ([Page 14, Paragraph 1] “aortic input impedance spectrum”; ([Page 3, Paragraph 2], “We applied advanced computational models to calculate… vascular impedance in patients before and after TAVR”) comprising a first vascular impedance value ([Page 3, Paragraph 2], vascular impedance in patients before…TAVR; [Page 21, Table 3] “Vascular impedance (Z0) Baseline”) and a second vascular impedance value ([Page 3, Paragraph 2], vascular impedance in patients after TAVR; [Page 21, Table 3] “Vascular impedance (Z0) 30 days post TAVR”;);
receiving (or determine for Claim 9) a blood pressure value for the patient ([Page 20] Table 2, “Brachial systolic BP, mmHg, Before TAVR”; [Page 8, All of Protocol for noninvasive central pressure measurements with SphygmoCor XCEL device Section] including, “A simple blood pressure (BP) cuff connected to the XCEL device was placed on a subject’s arm…Three consecutive BP measurements were taken, and the average of the final two were used for pulse waveform calibration.”)
determining that the first pressure waveform is a closer match to the blood pressure value than the second pressure waveform ([Page 20, Table 2] comparing both “Central systolic BP mmHg, Before TAVR” and “Central systolic BP mmHg, 30-days after TAVR” with a pre-surgery baseline “Brachial systolic BP, mmHg Before TAVR”. The difference in the mean is greater between the “30-days after TAVR“ and the baseline “Brachial systolic BP” (137.6 – 123.6 = 14) than the “Central systolic BP mmHg, Before TAVR” and the baseline “Brachial systolic BP” (137.6 – 127.5 = 10.1)); (Examiner notes that blood pressure value implies a singular numeric value. With this consideration, values from the “non-invasive central pressure” waveform would as those reported in Table 2, “central systolic BP mmHg” and “Central pulse pressure, mmHg” for “Before TAVR” and “30-days after TAVR” for the first and second “non-invasive central pressure” waveforms, respectively. If the blood pressure value of comparison is the “Before TAVR” brachial systolic BP in order to see patient progress, then the “Central systolic BP” for the patients before TAVR more closely matches that BP than the “Central systolic BP” from the waveform obtained after 30 days);
determining that the patient has a vascular impedance of the first vascular impedance value ([Page 21, Table 3] “Vascular impedance (Z0) Baseline”)(Examiner notes that the first vascular impedance is the vascular impedance that the patient was determined to have before the TAVR procedure).
optimizing aortic valve replacement selection by selecting patients to undergo valve replacement, as generated by the system based on the first vascular impedance value ([Page 6, 2nd Full Paragraph] “…vascular impedance metrics might direct the optimal timing of intervention (surgical AVR or TAVR)…”, “…these metrics might also identify patients who may not benefit from valve replacement….”)(Examiner notes that the data is selecting patients, or “identifying patients” who may not benefit from valve replacement based on the vascular impedance metrics, which means that they are also identifying those who could benefit and undergo valve replacement.)
Ben-Assa does not specifically disclose to predicting an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance; generating, by the one or more computer processors, a predicted outcome of an aortic valve replacement procedure for the patient based at least in part on the first vascular impedance value; when the predicted outcome for an aortic valve replacement procedure is positive ;and scheduling a selected patient for the valve replacement. Ben-Assa broadly discloses that “vascular impedance metrics might direct the optimal timing of intervention (surgical AVR or TAVR)”, and “these metrics might also identify patients who may not benefit from valve replacement.”
Hachicha teaches the prognostic value of valvuloarterial impedance in patients with aortic stenosis (AS). Specifically for Claim 1, Hachicha teaches A patient-specific computational modeling system for optimizing aortic valve replacement selection and predicting method to predict an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance ([Abstract]; [Page 1003, Results]; [Page 1006, Right Column Paragraph 6] – [Page 1007, Left Column, Paragraph 1])( (See 112b interpretation above as “A computational modeling system for predicting an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance.” Examiner notes that the threshold of greater than 3.5 indicates that a valve replacement would be “more protective” or recommended to increase chances of survival, vs just medical treatment. Therefore, the predicted outcome of an aortic valve replacement would be that it is “more protective” than medical treatment alone.)
and generating, by the one or more computer processors ([Page 8, Top] “…using the MATLAB software package”), a predicted outcome of an aortic valve replacement procedure for the patient based at least in part on the first vascular impedance value ([Page 1003, Results] “The risk of mortality was increased by 2.76-fold in patients with Zva > or = 4.5 mm Hg·ml_1·m2 and by 2.30-fold in those with a Zva between 3.5 and 4.5 mm Hg·ml_1·m2 after adjusting for other risk factors and type of treatment (surgical vs. medical).”; [Page 1006, Right Column Paragraph 6] – [Page 1007, Left Column, Paragraph 1] “…the magnitude of the protective effect of AVR was most important in patients with higher Zva (4-year survival: 87 ± 5% vs. 42 ± 9% for patients treated medically, p < 0.001) than in patients with moderate Zva (4-year survival: 89 ± 5% vs. 74 ± 4% for patients treated medically, p < 0.001).”,”..results seem to identify Zva > 3.5 mm Hg·ml-1·m2 as the logical threshold to identify patients likely to be at higher risk if treated medically rather than surgically.”)(Examiner notes that the threshold of greater than 3.5 indicates that a valve replacement would be “more protective” or recommended to increase chances of survival, vs just medical treatment. Therefore, the predicted outcome of an aortic valve replacement would be that it is “more protective” than medical treatment alone.)
when the predicted outcome for an aortic valve replacement procedure is positive ([Page 1003, Results] “The risk of mortality was increased by 2.76-fold in patients with Zva > or = 4.5 mm Hg·ml_1·m2 and by 2.30-fold in those with a Zva between 3.5 and 4.5 mm Hg·ml_1·m2 after adjusting for other risk factors and type of treatment (surgical vs. medical).”; [Page 1006, Right Column Paragraph 6] – [Page 1007, Left Column, Paragraph 1] “…the magnitude of the protective effect of AVR was most important in patients with higher Zva (4-year survival: 87 ± 5% vs. 42 ± 9% for patients treated medically, p < 0.001) than in patients with moderate Zva (4-year survival: 89 ± 5% vs. 74 ± 4% for patients treated medically, p < 0.001).”,”..results seem to identify Zva > 3.5 mm Hg·ml-1·m2 as the logical threshold to identify patients likely to be at higher risk if treated medically rather than surgically.”)(Examiner notes that a broadly positive outcome could be longer survival, as predicted by these metrics for certain subsets of patients.)
Hachicha’s recommendation regarding an aortic valve replacement procedure based on vascular impedance values would perform the same function of relating vascular impedance values to the success of an aortic valve replacement procedure if combined with Ben-Assa’s system and method to determine patients’ vascular impedance values. Therefore, it would have been predictable to use the vascular impedance-based aortic valve replacement result recommendation of Hachicha with any similar method or system that reports vascular impedance for patients, as it would continue to operate with the function of relating vascular impedance values to the success, or broadly positive outcome, of an aortic valve replacement procedure. Further, Ben-Assa discloses at [Page 6, All of Paragraph 3] including “Temporal tracking of SWLV and vascular impedance metrics might direct the optimal timing of intervention (surgical AVR or TAVR) and help define the nature of adjunctive medical care thereafter. Moreover, these metrics might also identify patients who may not benefit from valve replacement, as the ventricle may not be likely to recover due to a patient’s increased vascular impedance.” and so Ben-Assa is open to specific numeric thresholds to use to help “identify patients who may not benefit from valve replacement”, which could include the vascular impedance ranges and recommendations as taught by Hachicha.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system and method to determine patients’ vascular impedance values disclosed in Ben-Assa and relating success of an aortic valve replacement procedure to ranges of vascular impedance values taught by Hachicha, creating a single apparatus to calculate a patient’s vascular impedance and give them a prediction regarding an aortic valve replacement procedure success.
For the remainder of Claim 1, Hachicha does not specifically disclose scheduling a selected patient for the valve replacement.
HeartValveSurgery.com teaches surgeon-advice through a webinar held by Northwestern Medicine and HeartValveSurgery.com to help patients and surgeons understand when to schedule heart valve surgery, particularly in light of the likelihood of success and urgency of the valve replacement procedure ([Numbered Pages 28 and 36]) Specifically for Claim 1, HeartValveSurgery.com teaches optimizing aortic valve replacement selection by selecting patients to undergo valve replacement when the predicted outcome for an aortic valve replacement procedure is positive ([Numbered Page 28, 1st and 2nd Paragraph] “…Patients with aortic stenosis…heart failure…procedures can be urgent…”; [Numbered Page 36, 2nd Full Paragraph] “If she's in good health, now at age 72, and we wait until she's 78 or 80 and she's older and has more clinical problems and her heart disease has gotten worse, the risk to surgery is going to go up. This may be a better time to do it now -- when the risks are quite low...”)(Examiner notes that the outcome is broadly positive as the aortic valve replacement procedure at that time is indicated to reduce their likelihood of dying during the procedure later, and to treat their worsening heart disease”), and scheduling a selected patient for the valve replacement ([Numbered Page 28, 1st – 2nd Paragraph] “Some of the patients I saw today are going to be scheduling their surgery in a month or two...try to operate within 30 days…emergency surgery…that night or the next day”.)
HeartValveSurgery.com provides a motivation to combine at [Numbered Page 28, 1st and 2nd Paragraph] with “The vast majority of operations are elective…scheduling their surgery in a month or two…if they have a leaky valve like acute aortic insufficiency from an infection – endocarditis – many times that group of patients may need emergency surgery like that night of the next day.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that the idea of scheduling a patient for a procedure when it is deemed to be beneficial to them is a form of triage, to weigh the benefits and risks to determine the timing, then get the patient on the schedule in an amount of time relative to a positive outcome of surgery, as taught by HeartValveSurgery.com (such as 1 – 2 months, 30 days, or the same day).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system to determine patients’ vascular impedance values and predict a positive outcome of aortic valve replacement surgery disclosed in Ben-Assa in view of Hachicha with the triaging heart valve replacement decision weighing risks and benefits for surgery timing (1 – 2 months, 30 days, or the same day) taught by HeartValveSurgery.com, creating a single system to schedule a patient’s surgery a prediction regarding an aortic valve replacement procedure success.
Regarding Claim 2, Ben-Assa in view of Hachicha and HeartValveSurgery.com discloses as described above, The system of claim 1, respectively. For the remainder of Claim 2, Ben-Assa discloses the operations further comprising: filtering out the second pressure waveform based at least in part on one or more domain bounding criteria ([Page 8, Vascular impedance calculation Section, Paragraph 1] “Characteristic impedance (Zc) was calculated as the average of frequency 2–10 Hz, with frequencies greater than three times the median excluded (Fig. 1B).”)(Examiner notes that “excluding” the frequencies is a means to filter out inputs for the second pressure waveform).
Regarding Claim 4, Ben-Assa in view of Hachicha and HeartValveSurgery.com discloses as described above, The system of claim 1.
For the remainder of Claim 4, Ben-Assa does not disclose further comprising: generating a recommendation for an aortic valve replacement procedure for the patient based at least in part on the vascular impedance. Ben-Assa broadly discloses that “vascular impedance metrics might direct the optimal timing of intervention (surgical AVR or TAVR)”, and “these metrics might also identify patients who may not benefit from valve replacement.”
Specifically for Claim 4, Hachicha teaches further comprising: generating a recommendation for an aortic valve replacement procedure ([Page 1003, Methods] ” The primary end point for this study was the overall mortality regardless of the realization of aortic valve replacement (AVR).”) for the patient based at least in part on the vascular impedance ([Page 1003, Conclusions] “Increased Zva is a marker of excessive LV hemodynamic load, and a value > 3.5 successfully identifies patients with a poor outcome”; [Page 1006, Right Column Paragraph 6] – [Page 1007, Left Column, Paragraph 1] “…the magnitude of the protective effect of AVR was most important in patients with higher Zva (4-year survival: 87 ± 5% vs. 42 ± 9% for patients treated medically, p < 0.001) than in patients with moderate Zva (4-year survival: 89 ± 5% vs. 74 ± 4% for patients treated medically, p < 0.001).”,”..results seem to identify Zva > 3.5 mm Hg·ml-1·m2 as the logical threshold to identify patients likely to be at higher risk if treated medically rather than surgically.”)(Examiner notes that the threshold of greater than 3.5 indicates that a valve replacement would be “more protective” or recommended to increase chances of survival, vs just medical treatment.)
The motivation for Claim 4 to combine Ben-Assa with Hachicha is the same as that described in more detail in Claim 1. In summary, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system and method to determine patients’ vascular impedance values disclosed in Ben-Assa and relating success of an aortic valve replacement procedure to ranges of vascular impedance values taught by Hachicha, creating a single apparatus to calculate a patient’s vascular impedance and give them a recommendation regarding an aortic valve replacement procedure.
Regarding Claim 6, Ben-Assa in view of Hachicha and HeartValveSurgery.com discloses as described above, The system of claim 1.
For the remainder of Claim 6, Ben-Assa does not disclose wherein generating the predicted outcome comprises selecting the predicted outcome from a predefined set of outcomes. Ben-Assa broadly discloses that “vascular impedance metrics might direct the optimal timing of intervention (surgical AVR or TAVR)”, and “these metrics might also identify patients who may not benefit from valve replacement.”
Hachicha teaches wherein generating the predicted outcome comprises selecting the predicted outcome from a predefined set of outcomes ([Page 1007 - 1008, Discussion Section, Paragraphs 1 – 2] “…survival of patients treated surgically or with a low Zva (≤3.5 mm Hg·ml-1m2) was similar or better than that of the general population in Quebec is also compelling evidence that this parameter should be highly useful for risk stratification and clinical decision making and that the logical reference value for this purpose would seem to be a Zva > 3.5 mm Hg ml-1m2”).”)(Examiner notes that the set of outcomes is “survival”/death or not. The impedance is associated with “risk stratification” for that set of outcomes).
As explained in greater detail in Claim 1, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system and method to determine patients’ vascular impedance values disclosed in Ben-Assa and relating success of an aortic valve replacement procedure to ranges of vascular impedance values taught by Hachicha, creating a single apparatus to calculate a patient’s vascular impedance and give them a recommendation regarding an aortic valve replacement procedure.
Regarding Claim 7, Ben-Assa in view of Hachicha and HeartValveSurgery.com discloses as described above, The system of claim 1, wherein determining the first pressure waveform comprises. For the remainder of Claim 7 (and similarly for Claim 16), Ben-Assa discloses determining the first pressure waveform based at least in part on a Fourier Transform of the flow waveform and the first vascular impedance value ([Page 8, Vascular impedance calculation Section, Paragraph 1], “Aortic input impedance spectrums were calculated in the frequency domain using noninvasive central pressure waveforms recorded from the SphygmoCor and a velocity tracing from pulsed wave Doppler measured in the LVOT. Each waveform was decomposed into its Fourier harmonics.” [Page 14, Paragraph 1] “The aortic input impedance spectrum was derived using Fourier decomposition of the noninvasive central pressure and LVOT velocity waveforms.” [Page 3, Paragraph 2], “We applied advanced computational models to calculate… vascular impedance in patients before and after TAVR”)(Examiner notes that the waveforms were calculated before and after TAVR, thereby using the first and second waveform and impedance information. The first waveform and first impedance are associated with the patient prior to the TAVR procedure.).
Regarding Claim 17, Ben-Assa in view of Hachicha and HeartValveSurgery.com discloses as described above, The system of claim 1. For the remainder of Claim 17, Ben-Assa discloses wherein the data further comprises an aortic valve area value ([Page 22] Table 4, “Aortic valve area, cm^2”).
Regarding Claim 18, Ben-Assa in view of Hachicha and HeartValveSurgery.com discloses as described above, The system of claim 1. For the remainder of Claim 18, Ben-Assa discloses wherein the data is echocardiographic data ([Page 2, Abstract] “Left ventricular stroke work (SWLV) and vascular impedance spectrums were calculated noninvasively using in-house models based on central blood pressure waveforms, along with hemodynamic parameters from echocardiograms”)(Examiner notes that “echocardiogram” is an analogous word for “echocardiograph” in the art.)
Regarding Claim 20, Ben-Assa discloses A system comprising one or more computer processors ([Page 8, Top] “…using the MATLAB software package”) configured to determine the vascular impedance of a patient ([Page 7, Materials and Methods: Study Design Section, Paragraph 1] “...calculate left ventricular stroke work (SWLV) and vascular impedance spectrums using in-house computational models”; [Page 8, Vascular impedance calculation Section, All of Paragraph 1] including “SpygmoCor” and “via an in-house MATLAB program.”)(Examiner notes that MATLAB is a computer application that is used with a computer’s processors on a computer system.). For the remainder of Claim 20, Ben-Assa in view of Hachicha and HeartValveSurgery.com discloses as described above, according to the operations of claim 1.
Regarding Claim 21, Ben-Assa in view of Hachicha and HeartValveSurgery.com discloses as described above, The system of claim 1. For the remainder of Claim 21, Ben-Assa discloses wherein the data associated with the patient is received from at least one of an echocardiographic device ([Page 7, “Study Design” Section] “Data collection…dedicated echocardiography…”)(Examiner notes that “echocardiography” is performed with an “echocardiographic device”) or an ultrasound device, and the blood pressure value is received from an oscillometric device ([Fig 1. “noninvasive brachial blood pressure measurements captured with the SphygmoCor XCEL device”)(Examiner notes that the blood pressure cuff device is an oscillometric device.).
Claims 3 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Assa in view of Hachicha and HeartValveSurgery.com, further in view of Mynard, (“Measurement, Analysis and Interpretation of Pressure/Flow Waves in Blood Vessels”)
Regarding Claim 3, Ben-Assa in view of Hachicha and HeartValveSurgery.com discloses as described above, The system of claim 2.
For the remainder of Claim 3 and 14, Ben-Assa does not disclose wherein the one or more domain bounding criteria comprise pressure waveform upstroke (positive value), ejection duration range, and diastolic decay.
Mynard teaches a method to conduct wave analysis using a Westerhof triangle of heart and vascular characteristics. Specifically for Claim 3, Mynard teaches wherein the one or more domain bounding criteria comprise ([Page 10, Pressure-Only Wave Separation Section, All of Paragraph 1], including “Westerhof et al. (2006) originally proposed using a triangle to approximate systolic flow, with…” pressure waveform upstroke (positive value) ([Page 10, Pressure-Only Wave Separation Section, All of Paragraph 1], including “…a base spanning from the start of the pressure upstroke”), ejection duration range and a peak at 30% of ejection time or at the point of pressure inflection.”), and diastolic decay ([Page 10] “a triangle to approximate systolic flow, with a base spanning from the start of the pressure upstroke to the dicrotic notch”)(Examiner notes that diastolic delay is the time between the dicrotic notch and the next pressure upstroke).
Mynard teaches a prior art comparable device (vascular waveform calculation model) that uses domain bounding criteria of the Westerhof triangle with upstroke, ejection time, and diastolic delay for waveform calculations. For domain-bounding criteria, Ben-Assa broadly discloses data exclusion techniques, or bounding at [Page 8, Vascular impedance calculation Section] by “frequencies greater than three times the median excluded.” Ben-Assa discloses the motivation to combine Ben-Assa’s disclosure with Mynard’s teaching to determine useful components to “exclude”. Ben-Assa also discloses at [Page 8, Vascular impedance calculation Section] an importance of being able to compare results at “to allow for comparison of these vascular impedance metrics to other vascular load metrics used in the literature”. Mynard teaches a motivation to combine the disclosure of Ben-Assa with Mynard’s teaching at [Page 10, Pressure-Only Wave Separation Section] “With this approach, wave analysis can be conducted with only a pressure waveform and wave speed or characteristic impedance are not required.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that the Westerhof bounds could be used as a method to perform wave separation in a way to eliminate clearly non-physiologic parts of the model, and also be a way “to allow for comparison of these vascular impedance metrics to other vascular load metrics used in the literature”. A person of ordinary skill in the art before the effective filing date of the claimed invention would recognize that that using domain bounding criteria of the Westerhof triangle with upstroke, ejection time, and diastolic delay for waveform calculations, as Mynard teaches, would yield a more focused data model of human vascular physiology.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the vascular waveform calculation model disclosed in Ben-Assa and the domain bounding criteria of the Westerhof triangle with upstroke, ejection time, and diastolic delay for waveform calculations taught by Mynard, creating a single calculation apparatus with capability to calculate waveform characteristics with models more representative of patient vascular attributes.
Regarding Claim 19, Ben-Assa in view of Hachicha and HeartValveSurgery.com discloses as described above, The system of claim 1.
For the remainder of Claim 19, Ben-Assa does not disclose wherein the data is MRI data.
Mynard teaches an overview of techniques and concepts in the field of measurement, analysis, and interpretation of pressure and flow waves in blood vessels. Mynard teaches wherein the data is MRI data ([Page 4, Surrogate Measures of the Pressure Waveform Section, Paragraph 3] “Aortic cross-sectional area changes have been used as a surrogate of the central pressure waveform and can be obtained via phase contrast magnetic resonance imaging (MRI, Figure 2); [Page 5], Fig 2: Phase Contrast MRI, “for obtaining cross-sectional area or diameter waveforms and flow or mean velocity waveforms”)
Mynard teaches that MRI imaging can be used to obtain patient data concerning flow characteristics of the aorta and central pressure waveform for use in waveform calculations. This is the same function as Ben-Assa’s [Page 2, Abstract] “hemodynamic parameters from echocardiograms.” used for patient data informing waveform calculations. Ben-Assa discloses that part of their heart-associated models in the study are [Page 9, Paragraph 2] “validated with in vivo cardiac catheterization and MRI data.” Ben-Assa is open to combine to use MRI data, as using MRI data for more detailed vascular and soft tissue imaging is well-known in the art. Therefore, Ben-Assa discloses a motivation to substitute a different type of imaging, MRI, to use in calculations that are otherwise performed with echocardiogram data. Additionally, Mynard teaches at [Page 5, Non-invasive Measurement Section, Paragraphs 1 - 2] including “The gold-standard non-invasive method for measuring flow is phase contrast (PC-)MRI.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that using MRI to obtain flow data for a patient, as taught by Mynard, would yield a “gold standard” of useful data for more accurately calculating vascular impedance. Therefore, a person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that MRI imaging patient vascular data would also be useful for performing vascular impedance calculations for patients.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the “hemodynamic parameters from echocardiograms” of Ben-Assa with the flow data from “phase contrast MRI” of Mynard. Ben-Assa discloses measuring hemodynamic parameters with echocardiograms which is the same function of the measuring hemodynamic (flow) parameters with MRI in Mynard. Therefore it would yield a predictable result to substitute Mynard’s flow data from “phase contrast MRI” for the “hemodynamic parameters from echocardiograms” of Ben-Assa. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Claims 8 – 11, 13, and 15 - 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Assa et. al., (“Ventricular stroke work and vascular impedance refine the characterization of patients with aortic stenosis”) in view of Hachicha, et. al., (“Usefulness of the Valvuloarterial Impedance to Predict Adverse Outcome in Asymptomatic Aortic Stenosis”).
Regarding Claim 8, Ben-Assa discloses A patient-specific computational modeling system ([Abstract])(See 112b interpretation above as “A computational modeling system for predicting an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance.”), the system configured to execute operations ([Abstract]; [Page 3, Paragraph 2], “We applied advanced computational models”) comprising:
determining, by one or more computer processors coupled to memory ([Page 8, Vascular impedance calculation Section, All of Paragraph 1] including “SpygmoCor” and “via an in-house MATLAB program.”)(Examiner notes that MATLAB is a computer application that is used with a computer’s processors and is capable of saving files to memory), echocardiographic data associated with a patient ([Page 22] Table 4; [Page 9, Lumped parameter model and left ventricle stroke work calculation Section, Paragraph 1] “patient-specific echocardiographic measurements.”), the echocardiographic data ([Page 9, Lumped parameter model and left ventricle stroke work calculation Section, Paragraph 1] “All input parameters were obtained as patient-specific echocardiographic measurements.”) comprising a heart rate value ([Page 22] Table 4, “Heart rate, bpm”), a peak velocity through aortic valve value ([Page 22] Table 4, “Peak velocity, cm/sec”), an aortic valve area value, and a stroke volume value ([Page 22] Table 4, “Stroke volume Index, ml/m^2);
generating a flow waveform ([Page 8, Vascular impedance calculation Section, Paragraph 1] “…a velocity tracing”; [Page 14, Fig 1] “central velocity waveforms”) for the patient using the echocardiographic data ([Page 8, Vascular impedance calculation Section, Paragraph 1] “…a velocity tracing from pulsed wave Doppler measured in the LVOT”; [Page 14, Fig 1] “Valvular: Echocardiographic pulse wave Doppler tracings captured at the left ventricular outflow tract (LVOT), used to derive central velocity waveforms”)
determining a set of candidate vascular impedance values for the patient based at least in part on the flow waveform, the set of candidate vascular impedance values comprising a first vascular impedance value and a second vascular impedance value; determine a first pressure waveform using the flow waveform and the first vascular impedance value, determining a second pressure waveform using the flow waveform and the second vascular impedance value, determining a blood pressure value for the patient; determining that the first pressure waveform is a closer match to the blood pressure value than the second pressure waveform; determining that the patient has a vascular impedance of the first vascular impedance value; and optimizing aortic valve replacement selection by selecting patients to undergo valve, as generated by the system based on the first vascular impedance value (See citations above in Claim 1).
Ben-Assa does not disclose to predict an outcome of an aortic valve replacement procedure for a patient; and using the vascular impedance to determine whether the patient is a suitable candidate for an aortic valve replacement procedure; and generating a predicted outcome of an aortic valve replacement procedure for the patient based at least in part on the first vascular impedance value, and when the predicted outcome for an aortic valve replacement procedure is positive. Ben-Assa broadly discloses that “vascular impedance metrics might direct the optimal timing of intervention (surgical AVR or TAVR)”, and “these metrics might also identify patients who may not benefit from valve replacement.”
Hachicha teaches A patient-specific computational modeling system for optimizing aortic valve replacement selection and predicting method to predict an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance ([Abstract]; [Page 1003, Results]; [Page 1006, Right Column Paragraph 6] – [Page 1007, Left Column, Paragraph 1])( (See 112b interpretation above as “A computational modeling system for predicting an outcome of an aortic valve replacement procedure for a patient by determining vascular impedance.” Examiner notes that the threshold of greater than 3.5 indicates that a valve replacement would be “more protective” or recommended to increase chances of survival, vs just medical treatment. Therefore, the predicted outcome of an aortic valve replacement would be that it is “more protective” than medical treatment alone.)
using the vascular impedance to determine whether the patient is a suitable candidate for an aortic valve replacement procedure ([Page 1003, Conclusions] “Increased Zva is a marker of excessive LV hemodynamic load, and a value > 3.5 successfully identifies patients with a poor outcome”; [Page 1006, Right Column Paragraph 6] – [Page 7, Left Column, Paragraph 1] “…the magnitude of the protective effect of AVR was most important in patients with higher Zva (4-year survival: 87 ± 5% vs. 42 ± 9% for patients treated medically, p < 0.001) than in patients with moderate Zva (4-year survival: 89 ± 5% vs. 74 ± 4% for patients treated medically, p < 0.001).”,”..results seem to identify Zva > 3.5 mm Hg·ml-1·m2 as the logical threshold to identify patients likely to be at higher risk if treated medically rather than surgically.”)(Examiner notes that the threshold of greater than 3.5 indicates that a valve replacement would be “more protective” or recommended to increase chances of survival, vs just medical treatment.); and generating a predicted outcome of an aortic valve replacement procedure for the patient based at least in part on the first vascular impedance value ([Page 1003, Results] “The risk of mortality was increased by 2.76-fold in patients with Zva > or = 4.5 mm Hg·ml_1·m2 and by 2.30-fold in those with a Zva between 3.5 and 4.5 mm Hg·ml_1·m2 after adjusting for other risk factors and type of treatment (surgical vs. medical).”; [Page 1006, Right Column Paragraph 6] – [Page 7, Left Column, Paragraph 1] “…the magnitude of the protective effect of AVR was most important in patients with higher Zva (4-year survival: 87 ± 5% vs. 42 ± 9% for patients treated medically, p < 0.001) than in patients with moderate Zva (4-year survival: 89 ± 5% vs. 74 ± 4% for patients treated medically, p < 0.001).”,”..results seem to identify Zva > 3.5 mm Hg·ml-1·m2 as the logical threshold to identify patients likely to be at higher risk if treated medically rather than surgically.”)(Examiner notes that the threshold of greater than 3.5 indicates that a valve replacement would be “more protective” or recommended to increase chances of survival, vs just medical treatment. Therefore, the predicted outcome of an aortic valve replacement would be that it is “more protective” than medical treatment alone.)
when the predicted outcome for an aortic valve replacement procedure is positive ([Page 1003, Results] “The risk of mortality was increased by 2.76-fold in patients with Zva > or = 4.5 mm Hg·ml_1·m2 and by 2.30-fold in those with a Zva between 3.5 and 4.5 mm Hg·ml_1·m2 after adjusting for other risk factors and type of treatment (surgical vs. medical).”; [Page 1006, Right Column Paragraph 6] – [Page 1007, Left Column, Paragraph 1] “…the magnitude of the protective effect of AVR was most important in patients with higher Zva (4-year survival: 87 ± 5% vs. 42 ± 9% for patients treated medically, p < 0.001) than in patients with moderate Zva (4-year survival: 89 ± 5% vs. 74 ± 4% for patients treated medically, p < 0.001).”,”..results seem to identify Zva > 3.5 mm Hg·ml-1·m2 as the logical threshold to identify patients likely to be at higher risk if treated medically rather than surgically.”)(Examiner notes that a broadly positive outcome could be longer survival, as predicted by these metrics for certain subsets of patients.)
Hachicha’s recommendation regarding an aortic valve replacement procedure based on vascular impedance values would perform the same function of relating vascular impedance values to the success of an aortic valve replacement procedure if combined with Ben-Assa’s system and method to determine patients’ vascular impedance values. Therefore, it would have been predictable to use the vascular impedance-based aortic valve replacement result recommendation of Hachicha with any similar method or system that reports vascular impedance for patients, as it would continue to operate with the function of relating vascular impedance values to the success, or positive outcome, of an aortic valve replacement procedure. Further, Ben-Assa discloses at [Page 6, All of Paragraph 3] including “Temporal tracking of SWLV and vascular impedance metrics might direct the optimal timing of intervention (surgical AVR or TAVR) and help define the nature of adjunctive medical care thereafter. Moreover, these metrics might also identify patients who may not benefit from valve replacement, as the ventricle may not be likely to recover due to a patient’s increased vascular impedance.” and so Ben-Assa is open to specific numeric thresholds to use to help “identify patients who may not benefit from valve replacement”, which could include the vascular impedance ranges and recommendations as taught by Hachicha. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system and method to determine patients’ vascular impedance values disclosed in Ben-Assa and relating success of an aortic valve replacement procedure to ranges of vascular impedance values taught by Hachicha, creating a single apparatus to calculate a patient’s vascular impedance and give them a recommendation regarding an aortic valve replacement procedure.
Regarding generating a predicted outcome… the motivation for Claim 8 to combine Ben-Assa and Hachichi is the same as that described in more detail in Claim 1. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system and method to determine patients’ vascular impedance values disclosed in Ben-Assa and relating success of an aortic valve replacement procedure to ranges of vascular impedance values taught by Hachicha, creating a single apparatus to calculate a patient’s vascular impedance and give them a prediction regarding an aortic valve replacement procedure success.
Regarding Claim 9, Ben-Assa discloses A device ([Page 8, Paragraph 1] “in-house tool using the MATLAB software package (MathWorks, Inc.)”; [Page 3, Paragraph 2] “advanced computational models”); comprising:
memory configured to store computer-executable instructions (Page 14, Fig 1] “Computer-based”)(Examiner notes that a computer-based system routinely has a memory, and that memory is configured to store executable instructions); and
at least one computer processor configured to access the memory and execute the computer-executable instructions ([Page 8, Vascular impedance calculation Section, All of Paragraph 1] including “SpygmoCor” and “via an in-house MATLAB program.”)(Examiner notes that MATLAB is a computer application that is used with a computer’s processors and is capable of accessing and executing files stored to memory), to:
For the remainder of Claim 9, Ben-Assa discloses as described above in Claim 1, determine data associated with a patient, the data comprising a heart rate value, a peak velocity through aortic valve value, and a stroke volume value; generate a flow waveform for the patient using the data; determine a set of candidate vascular impedance values for the patient based at least in part on the flow waveform, the set of candidate vascular impedance values comprising a first vascular impedance value and a second vascular impedance value; determine a blood pressure value for the patient; determine that a first pressure waveform is a closer match to the blood pressure value than a second pressure waveform; determine that the patient has a vascular impedance of the first vascular impedance value; and optimizing aortic valve replacement selection by selecting patients to undergo valve, as generated by the system based on the first vascular impedance value (See citations above in Claim 1).
As described above in Claim 1, Ben-Assa does not particularly disclose generate a predicted outcome of an aortic valve replacement procedure for the patient based at least in part on the first vascular impedance value and when the predicted outcome for an aortic valve replacement procedure is positive. Ben-Assa does disclose that “vascular impedance metrics might direct the optimal timing of intervention (surgical AVR or TAVR)”, and “these metrics might also identify patients who may not benefit from valve replacement.”
Hachicha teaches and generate a predicted outcome of an aortic valve replacement procedure for the patient based at least in part on the first vascular impedance value ([Page 1003, Results] “The risk of mortality was increased by 2.76-fold in patients with Zva > or = 4.5 mm Hg·ml_1·m2 and by 2.30-fold in those with a Zva between 3.5 and 4.5 mm Hg·ml_1·m2 after adjusting for other risk factors and type of treatment (surgical vs. medical).”; [Page 1006, Right Column Paragraph 6] – [Page 1007, Left Column, Paragraph 1] “…the magnitude of the protective effect of AVR was most important in patients with higher Zva (4-year survival: 87 ± 5% vs. 42 ± 9% for patients treated medically, p < 0.001) than in patients with moderate Zva (4-year survival: 89 ± 5% vs. 74 ± 4% for patients treated medically, p < 0.001).”,”..results seem to identify Zva > 3.5 mm Hg·ml-1·m2 as the logical threshold to identify patients likely to be at higher risk if treated medically rather than surgically.”)(Examiner notes that the threshold of greater than 3.5 indicates that a valve replacement would be “more protective” or recommended to increase chances of survival, vs just medical treatment. Therefore, the predicted outcome of an aortic valve replacement would be that it is “more protective” than medical treatment alone.)
when the predicted outcome for an aortic valve replacement procedure is positive ([Page 1003, Results] “The risk of mortality was increased by 2.76-fold in patients with Zva > or = 4.5 mm Hg·ml_1·m2 and by 2.30-fold in those with a Zva between 3.5 and 4.5 mm Hg·ml_1·m2 after adjusting for other risk factors and type of treatment (surgical vs. medical).”; [Page 1006, Right Column Paragraph 6] – [Page 1007, Left Column, Paragraph 1] “…the magnitude of the protective effect of AVR was most important in patients with higher Zva (4-year survival: 87 ± 5% vs. 42 ± 9% for patients treated medically, p < 0.001) than in patients with moderate Zva (4-year survival: 89 ± 5% vs. 74 ± 4% for patients treated medically, p < 0.001).”,”..results seem to identify Zva > 3.5 mm Hg·ml-1·m2 as the logical threshold to identify patients likely to be at higher risk if treated medically rather than surgically.”)(Examiner notes that a broadly positive outcome could be longer survival, as predicted by these metrics for certain subsets of patients.)
The motivation for Claim 9 to combine Ben-Assa with Hachicha is the same as that described in more detail above for Claim 1. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system to determine patients’ vascular impedance values disclosed in Ben-Assa with relating success of an aortic valve replacement procedure to ranges of vascular impedance values taught by Hachicha, creating a single apparatus to calculate a patient’s vascular impedance and give them a prediction regarding an aortic valve replacement procedure success.
Regarding Claim 10, Ben-Assa in view of Hachicha discloses as described above, The system of claim 1. For the remainder of Claim 10, Ben-Assa discloses wherein the data further comprises an aortic valve area value ([Page 22] Table 4, “Aortic valve area, cm^2”).
Regarding Claims 11, Ben-Assa in view of Hachicha discloses as described above, The system of claim 1. For the remainder of Claim 11, Ben-Assa discloses wherein the data is echocardiographic data ([Page 2, Abstract] “Left ventricular stroke work (SWLV) and vascular impedance spectrums were calculated noninvasively using in-house models based on central blood pressure waveforms, along with hemodynamic parameters from echocardiograms”)(Examiner notes that “echocardiogram” is an analogous word for “echocardiograph” in the art.)
Regarding Claim 13, Ben-Assa in view of Hachicha discloses as described above, The device of claim 9. For the remainder of Claim 13, Ben-Assa discloses wherein the at least one computer processor is further configured to access the memory and execute the computer-executable instructions to ([Page 8, Vascular impedance calculation Section, All of Paragraph 1] including “SpygmoCor” and “via an in-house MATLAB program.”)(Examiner notes that MATLAB is a computer application that is used with a computer’s processors and is capable of saving files to memory).
filter out the second pressure waveform based at least in part on one or more domain bounding criteria ([Page 8, Vascular impedance calculation Section, Paragraph 1] “Characteristic impedance (Zc) was calculated as the average of frequency 2–10 Hz, with frequencies greater than three times the median excluded (Fig. 1B).”)(Examiner notes that “excluding” the frequencies is a means to filter out inputs for the second pressure waveform).
Regarding Claim 15, Ben-Assa in view of Hachicha discloses as described above in Claim 9, The device of claim 9, wherein the at least one computer processor. For the remainder of Claim 15, Ben-Assa discloses is further configured to access the memory and execute the computer-executable instructions to ([Page 8, Vascular impedance calculation Section, All of Paragraph 1] including “SpygmoCor” and “via an in-house MATLAB program.”)(Examiner notes that MATLAB is a computer application that is used with a computer’s processors and is capable of accessing and executing files saved to memory): determine the first pressure waveform based at least in part on a Fourier Transform of the flow waveform and the first vascular impedance value ([Page 8, Vascular impedance calculation Section, Paragraph 1], “Aortic input impedance spectrums were calculated in the frequency domain using noninvasive central pressure waveforms recorded from the SphygmoCor and a velocity tracing from pulsed wave Doppler measured in the LVOT. Each waveform was decomposed into its Fourier harmonics.” [Page 14, Paragraph 1] “The aortic input impedance spectrum was derived using Fourier decomposition of the noninvasive central pressure and LVOT velocity waveforms.” [Page 3, Paragraph 2], “We applied advanced computational models to calculate… vascular impedance in patients before and after TAVR”)(Examiner notes that the waveforms were calculated before and after TAVR, thereby using the first and second waveform and impedance information. The first waveform and first impedance are associated with the patient prior to the TAVR procedure. Examiner further notes the 112(b) rejection and interpretation above, such that for the purposes of examination, the “and” is chosen, including all of the recited limitations. If the “or” had been chosen for each of the “and-or” recited in Claim 15, as described in the 112(b) rejection above, then the only required step is “determine the first pressure waveform based at least in part on a Fourier Transform of the flow waveform and the first vascular impedance value.” In that case, Ben-Assa would disclose all of the required elements of this claim.)
Ben-Assa does not disclose generate (i) a recommendation for an aortic valve replacement procedure for the patient
Hachicha teaches generate (i) a recommendation for an aortic valve replacement procedure for the patient ([Page 1003, Methods] ” The primary end point for this study was the overall mortality regardless of the realization of aortic valve replacement (AVR).”) ([Page 1003, Conclusions] “Increased Zva is a marker of excessive LV hemodynamic load, and a value > 3.5 successfully identifies patients with a poor outcome”; [Page 1006, Right Column Paragraph 6] – [Page 7, Left Column, Paragraph 1] “…the magnitude of the protective effect of AVR was most important in patients with higher Zva (4-year survival: 87 ± 5% vs. 42 ± 9% for patients treated medically, p < 0.001) than in patients with moderate Zva (4-year survival: 89 ± 5% vs. 74 ± 4% for patients treated medically, p < 0.001).”,”..results seem to identify Zva > 3.5 mm Hg·ml-1·m2 as the logical threshold to identify patients likely to be at higher risk if treated medically rather than surgically.”)(Examiner notes that the threshold of greater than 3.5 indicates that a valve replacement would be “more protective” or recommended to increase chances of survival, vs just medical treatment.)
The motivation for Claim 15 to combine Ben-Assa and Hachicha is the same as that described in more detail in Claim 1. In summary, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system and method to determine patients’ vascular impedance values disclosed in Ben-Assa and relating success of an aortic valve replacement procedure to ranges of vascular impedance values taught by Hachicha, creating a single apparatus to calculate a patient’s vascular impedance and give them a recommendation regarding an aortic valve replacement procedure.
Regarding Claim 16, Ben-Assa in view of Hachicha discloses as described above in Claim 8, The method of claim 8. For the remainder of Claim 16, Ben-Assa discloses as above in Claim 7, wherein determining the first pressure waveform comprises determining the first pressure waveform based at least in part on a Fourier Transform of the flow waveform and the first vascular impedance value (see rejection of Claim 7 above).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Assa in view of Hachicha, further in view of Mynard, (“Measurement, Analysis and Interpretation of Pressure/Flow Waves in Blood Vessels”)
Regarding Claim 12, Ben-Assa in view of Hachicha and HeartValveSurgery.com discloses as described above, The device of claim 9.
For the remainder of Claim 12, Ben-Assa does not disclose wherein the data is MRI data.
As described above in Claim 19, Mynard teaches wherein the data is MRI data (See citation in Claim 19 above).
The motivation for Claim 12 to combine Ben-Assa with Mynard is the same as that described in more detail above for Claim 19. In summary, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the “hemodynamic parameters from echocardiograms” of Ben-Assa with the flow data from “phase contrast MRI” of Mynard. Ben-Assa discloses measuring hemodynamic parameters with echocardiograms which is the same function of the measuring hemodynamic (flow) parameters with MRI in Mynard. Therefore it would yield a predictable result to substitute Mynard’s flow data from “phase contrast MRI” for the “hemodynamic parameters from echocardiograms” of Ben-Assa.
Regarding Claim 14, Ben-Assa in view of Hachicha discloses as described above, The device of claim 13.
For the remainder of Claim 14, Ben-Assa does not disclose wherein the one or more domain bounding criteria comprise pressure waveform upstroke (positive value), ejection duration range, and diastolic decay.
As described above in Claim 3, Mynard teaches wherein the one or more domain bounding criteria comprise pressure waveform upstroke (positive value), ejection duration range, and diastolic decay (See citation above in Claim 3).
The motivation for Claim 14 to combine Ben-Assa with Mynard is the same as that described in more detail above for Claim 3. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the vascular waveform calculation model disclosed in Ben-Assa and the domain bounding criteria of the Westerhof triangle with upstroke, ejection time, and diastolic delay for waveform calculations taught by Mynard, creating a single calculation apparatus with capability to calculate waveform characteristics with models more representative of patient vascular attributes.
Response to Arguments
Applicant's arguments filed 18 MARCH 2026 have been fully considered but they are not persuasive.
Regarding 35 U.S.C. 101 Rejections:
Applicant argues at [Page 7, “Rejections under 35 U.S.C. 101” Section] – [Page 9, Top] that the claims as a whole integrate any recited judicial exceptions into a practical application under Step 2A, Prong Two, since the amended claims are analogous to USPTO Subject Matter Eligibility Example 49 claim 2. Applicant further argues the similarity with the example because amended claims 1, 8, and 9 use the alleged abstract idea (vascular impedance determination and outcome prediction) to identify the patient as belonging to a specific patient population and then apply a particular treatment of the aortic valve replacement procedure specific to that patient population. It is important to note that there are currently-applied 112(a) rejections to the “optimize…” limitation, as lacking written description support in Applicant’s specification. Furthermore, there is a lack of clarity of if patient is actually undergoing valve replacement surgery, or if they are merely being selected to have a surgery at some point in the future. There is nothing particularly recited in the claim that clearly, positively performs the surgery, nor are there elements disclosed in the system to perform the surgery. Rather, the limitation can broadly be interpreted as a human writing down a person’s name on a page to indicate that they would be a good candidate to eventually “undergo valve replacement”. The example 49, claims 1 and 2 include the limitations “(c) administering an appropriate treatment to the glaucoma patient…” and “wherein the appropriate treatment is Compound X eye drops”. There is a positively-recited treatment of physical eye drops being administered to the patient. There is not a positively-recited physical treatment being administered to the patient with the apparatuses of claims 1, 8, and 9. The argument is not persuasive.
Applicant summarily argues at [Page 9, 1st Full Paragraph] that the amended claims integrate the judicial exception into a practical application and are patent eligible under 35 U.S.C. 101. Based on the 35 U.S.C 101 analysis herein and the discussion of arguments above, Claims1 – 4 and 6 – 21 do not qualify as eligible subject matter under 35 U.S.C. 101. The argument is not persuasive.
Regarding 35 U.S.C. 103 Rejections:
Applicant argues at [Page 9, “Rejections under 35 U.S.C. 103” Section] – [Page 10, 1st Full Paragraph] that none of the cited references teach or suggest the elements of “optimize aortic valve replacement selection by selection patients…as generated by the system based on the first vascular impedance value” and “schedule a selected patient for the valve replacement”. It is noted that there are currently-applied 112(a) rejections to the “optimize…” and the “scheduling…” limitations, as lacking written description support in Applicant’s specification. In the interest of compact prosecution, based on the 35 U.S.C. 103 rejection above, Ben Assa in view of Hachicha discloses “optimize aortic valve replacement selection by selecting patients…as generated by the system based on the first vascular impedance value” (See 112(b) rejection above and interpretation) at [Page 6, 2nd Full Paragraph] by identifying patients who may not (or may) benefit from valve replacement based on their vascular impedance metrics (See citation above). Regarding the amendment-added scheduling limitation, Ben Assa and Hachicha are combined with the newly-added HeartValveSurgery.com reference to teach the limitation. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The argument is not persuasive.
Applicant argues at [Page 10, 2nd Full Paragraph] that the claims (including 8 and 9) set forth a computational methodology that is not taught by the cited references, since the cited references measure impedance values directly at different time points, rather than using candidate impedance values to generate pressure waveforms for comparison. It is noted that how the first and second pressure waveform are obtained is not specified in Claim 9. Regarding Claims 1 and 8, for the limitation “determining a first pressure waveform using the flow waveform and the first vascular impedance value” and “determining a second pressure waveform using the flow waveform and the second vascular impedance value”, it is not particularly recited that candidate impedance values are used to generate pressure waveforms for comparison. As recited, the flow waveform and the vascular impedance value are used, which could broadly include measuring multiple flow waveforms at two time periods and noting the waveform and impedance information, as disclosed in Ben-Assa at ([Page 14, Fig 1] “…the SphygmoCor XCEL device, used to derive peripheral (brachial) and central (aortic) pressure waveforms; [Page 21, Table 3] “Vascular impedance (Z0) Baseline”; [Page 14, Paragraph 1] “The aortic input impedance spectrum was derived using Fourier decomposition of the noninvasive central pressure and LVOT velocity waveforms; [Page 3, Paragraph 2], “We applied advanced computational models to calculate…vascular impedance in patients before and after TAVR”)(Examiner notes that the waveforms were calculated before and after TAVR, thereby using the first and second waveform and impedance information. The first waveform and first impedance are associated with the patient prior to the TAVR procedure.)
It is not positively recited that the first and second pressure waveforms are generated after the flow waveform and candidate first and second vascular impedance values, based only on the flow waveform and the candidate first or second vascular impedance value. The argument is not persuasive.
Applicant summarily argues at [Page 10, 3rd Full Paragraph] that none of the cited references, alone or in combination, teach of suggest each and every element of claim 1 and the similar claims 8 and 9. Based on the 35 U.S.C. 103 rejection analysis above and the discussion above, Ben Assa with Hachicha and HeartValveSurgery.com combine to teach the limitations of Claim 1, and Ben Assa and Hachicha combine to disclose the limitations of claims 8, and 9. The argument is not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791
Prosecution Insights