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 .
Amendment
This action is in response to the Amendment filed on 10/14/2025.
Claims 1-10, 13-16, 19, 28, 29 and 32 are pending.
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive.
Rejections under 35 U.S.C. 101
Independent claims 1, 15 and 18 have been amended to recite:
"configuring the heart pump to estimate flow through the heart pump during operation when implanted in a patient, wherein configuring the heart pump to estimate flow through the heart pump comprises associating in at least one memory of the heart pump, the maximum flow value and the predetermined motor current speed."
Applicant’s arguments that amended independent claim 1 does not recite a mental process is not persuasive.
Independent claim 1 recites the steps of:
receiving data relating motor current to differential pressure measured for a predetermined speed of a motor of the heart pump;
extrapolating based on the received data, a first value for the motor current at which the differential pressure is zero;
determining a maximum flow value through the heart pump at the predetermined speed of the motor of the heart pump based, at least in part, on the first value for the motor current; and
configuring the heart pump to estimate flow through the heart pump during operation when implanted in a patient by associating in at least one memory of the heart pump, the maximum flow value and the predetermined speed of the motor of the heart pump.
Step 1 that recites receiving data and is a pre-solution data collection activity.
Steps 2 and 3 recite the abstract idea that comprises extrapolating a value for the motor current at a zero differential pressure and determining a maximum flow value at the predetermined speed based on the extrapolated value. The claim does not recite any steps of how the maximum flow value is calculated and the steps could include doing simple math and/or determining the maximum flow value based on experience of a clinician by merely extrapolating the first motor current values data by reviewing the collected data and performing some correlation or mathematical steps.
Therefore the abstract idea can be performed by a clinician by merely viewing the received data and performing mental/paper calculations or based on their experience.
The newly amended step 4 that recites that the pump estimates the flow during operation while the pump is implanted in the patient by “associating” (interpreted as storing) in a memory of the heart pump the maximum flow value and predetermined speed is just post-solution activity of recording the calculated information which can also be done manually by simply recording the values.
Additionally, independent claim 15 does not even positively recite a memory.
Applicant’s argument that the claimed invention improves the functioning of another technology namely a heart pump is not persuasive.
While they argue that the claims relate to configuring a heart pump with stored maximum flow value information to enable the heart pump to more accurately estimate flow through the heart pump during operation after the pump is implanted in the heart of a patient, resulting in an improved heart pump device, the improvement lies in the determination of the maximum flow value and not in the improvement of the heart pump. The claims do not recite any additional step of adjusting the pump to improve the flow based on the calculated results. The claim as recited just estimates the maximum flow values and stores them in the memory of the heart pump and does not adjust the functioning of the heart pump. Therefore the improvement lies in the abstract idea and does not provide any improvement in the functioning of the heart pump itself. Further, the claimed processor and memory (e.g. [0043] of the applicant’s specifications) is reasonably construed as a generic computing device. Therefore it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available processors that are used to estimate and store calculated values based on collected data.
Independent claims 15 and 18 also recite similar limitations and therefore the rejection has been maintained.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10, 13-16, 19, 28, 29 and 32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1, 15 and 28 recite a method, a heart pump and a controller for a heart pump for performing the steps of:
receiving data relating motor current to differential pressure measured for a predetermined speed of a motor of the heart pump;
extrapolating based on the received data, a first value for the motor current at which the differential pressure is zero;
determining a maximum flow value through the heart pump at the predetermined speed of the motor of the heart pump based, at least in part, on the first value for the motor current and
configuring the heart pump to estimate flow through the heart pump during operation when implanted in a patient by associating in at least one memory of the heart pump, the maximum flow value and the predetermined speed of the motor of the heart pump.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. Each of the instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed to a method, claim 15 is directed to a heart pump and claim 28 is directed to a controller, and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1, 15 and 28 recite a method, a heart pump and a controller for a heart pump that perform the following steps comprising:
receiving data relating motor current to differential pressure measured for a predetermined speed of a motor of the heart pump;
extrapolating based on the received data, a first value for the motor current at which the differential pressure is zero;
determining a maximum flow value through the heart pump at the predetermined speed of the motor of the heart pump based, at least in part, on the first value for the motor current and
configuring the heart pump to estimate flow through the heart pump during operation when implanted in a patient by associating in at least one memory of the heart pump, the maximum flow value and the predetermined speed of the motor of the heart pump.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, claims 1, 15, and 28 recite an abstract idea of a mental process.
The limitations as drafted in the claims, under its broadest reasonable interpretation, covers performance of the claimed steps in the mind, but for the recitation of a generic processor. Other than reciting a generic processer and memory, nothing in the elements of the claims precludes the step from practically being performed in the mind or manually by a clinician. For example a clinician can receive data relating motor current to differential pressure measured for a predetermined speed of a motor of the heart pump as a printed data set, extrapolate based on the received data, a first value for the motor current at which the differential pressure is zero, determine a maximum flow value through the heart pump at the predetermined speed of the motor of the heart pump based, at least in part, on the first value for the motor current and measure flow through the heart pump based, at least in part, on the determined maximum flow value by associating the maximum flow value and the predetermined motor current speed. As discussed above the first step of receiving data is pre-solution activity of data collection and the step of associating in the memory of the heart pump, the maximum flow value and the predetermined speed is post-solution activity of recording results based on processing.
Further, dependent claims 2-10, 13-14,16,19,29 and 32 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
The above-identified abstract idea in each of independent Claims 1, 15 and 28 and their respective dependent claims, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use.
More specifically, the additional elements of a “processor”, “rotor”, “motor” and “memory” are generically recited elements in independent claims and their dependent claims 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. However, these elements are recited at a high level of generality performing the function of generic data processing such that they amount to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f). Accordingly, the additional elements do not integrate the abstract idea into a practical application.
Moreover, the above-identified abstract idea is not integrated into a practical application because the claimed method and system merely implements the above-identified abstract idea (e.g. mental process) by a computer (e.g. 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. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1,15 and 28 (and their respective dependent claims) is not integrated into a practical application
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea for at least the following reasons.
As discussed above with respect to integration of the abstract idea into a practical application, these claims require the additional elements of: a “processor”, “rotor”, “motor” and “memory”. Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example Moyer et al (U.S. Patent Application Publication Number: US 2018/0353667 A1, hereinafter “Moyer”), Greatrex et al (U.S. Patent Application Publication Number: US 2018/0311422 A1, hereinafter “Greatrex”), Edelman et al (U.S. Patent Application Publication Number: US 2018/0080078159 A1, hereinafter “Edelman”), Timms et al (U.S. Patent Application Publication Number: US 2012/0095280 A1, hereinafter “Timms”) are among many teachings that teach blood pumps comprising a rotor, motor, processor and memory and therefore these are conventional limitations that amount to mere instructions or elements to implement the abstract idea. Further, in light of Applicant’s specification, the claimed processor and memory (e.g. [0043] of the applicant’s specifications) is reasonably construed as a generic computing device. Therefore it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available processors, with their already available basic functions, to use as tools in executing the claimed process. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. Therefore, the claims are not patent eligible.
Note: The claims as recited do not positively recite any additional steps performed by the processor/controller to correct or readjust the motor speed and/or current based on the analysis.
While no prior art rejections have been applied, the claims are not considered as allowable due to the rejection under 35 U.S.C. 101 discussed above.
Conclusion
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792