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 .
Response to Amendment
Claims 28-42 and 46-51 are currently pending. Claims 28-25 remain withdrawn. Claims 36, 37, 39, 42, and 46 have been amended. Claim 39 has been amended to overcome the 35 U.S.C. 112(b) rejection set forth in the Non-Final Office Action mailed on 08 September 2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the impeller configured to be rotated within the patient’s blood vessel, as mentioned in claim 36, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 36 is 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. Claims 37-42 are further rejected due to their dependency to claim 36.
Claim 36 recites “an impeller configured to be rotated within the patient’s blood vessel” in lines 2-3. However, [0051] of the PGPUB reads “an impeller blade on the drive shaft may be rotated within a pump housing 134 to induce a flow of blood into the cannula 173 at a suction head 174,” indicating that the impeller is within the pump housing, not the blood vessel. As such, the claims are interpreted as “an impeller configured to be rotating the patient’s blood.”
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 36-42 and 46-51 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 36 and 46 follows.
CLAIM 36:
STEP 1
Regarding claim 36, the claim recites a series of structural elements, including a hemodynamic sensor. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of detecting a change in a hemodynamic parameter resulting from the induced blood flow and receiving a sensor signal set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 36 recites calculating resistance of the blood vessel as a function of blood flow within the blood vessel and aortic pressure, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The calculation of resistance of the blood vessel does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the calculated resistance of the blood vessel, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites the additional step of inducing blood flow within a patient’s blood vessel. Inducing blood flow is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the inducing step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining step does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 36, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited system including an impeller is a generic sensor configured to perform a step necessary to perform the Abstract Idea and the hemodynamic sensor and the computer are configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claim. Claims 37, 39-41, 46-48, 50, and 51 recite steps that add to the Abstract Idea. Claims 38 and 49 recite additional elements that are not significantly more. Claim 42 recite the insignificant pre-solutional step of data gathering. The comparing and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
CLAIM 46:
STEP 1
Regarding claim 46, the claim recites a series of structural elements, including a hemodynamic sensor. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
a system for inducing blood flow within a patient’s blood vessel;
a hemodynamic sensor configured to detect a change in a hemodynamic parameter resulting from the induced blood flow;
a controller configured to calculate resistance of the blood vessel as a function of blood flow within the blood vessel and aortic pressure;
the controller configured to detect change in resistance of impeller rotation within the blood vessel;
the controller configured to calculated, based on the change in resistance of impeller rotation, vascular compliance and vascular resistance using a transfer function; and
the controller configured to maintain a constant impeller rotational speed, based on the detected resistance of impeller rotation
set forth a judicial exception. The inducing and maintain steps describe a concept of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). Thus, the claim is drawn to Organizing Human Activity. The calculating and detecting steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is also an Abstract Idea. The calculating steps also describe mathematical relationships, mathematical formulas or equations, mathematical calculations. Thus, the claim is also drawn to Mathematical Concepts, which is also an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 46 recites the controller configured to transmit pump operation data to a non-transient computing device, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The transmission of pump operation data does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the transmitted pump operation data, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites the additional step of a hemodynamic sensor configured to detect change in a hemodynamic parameter resulting from the induced blood flow. Detecting change in hemodynamic parameters is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the detecting step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining step does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 46, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited hemodynamic sensor is a generic sensor configured to perform a step necessary to perform the Abstract Idea and the system and the computer are configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claim. Claims 47, 48, 50, and 51 recite steps that add to the Abstract Idea. Claim 49 recites additional elements that are not significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Franano et al. ‘559 (US Pub No. 2013/0338559 – previously cited).
Regarding claim 36, Franano et al. ‘559 teaches a blood vessel sensor comprising:
a system for inducing blood flow within a patient’s blood vessel (Fig. 1 blood pump system and [0100]), the system including an impeller configured to be rotated within the patient’s blood vessel (Fig. 2 impeller blades 235 and [0108]);
a hemodynamic sensor configured to detect a change in a hemodynamic parameter resulting from the induced blood flow (Fig. 36A block 604 and [0178]; “ultrasonic flow sensor”); and
a controlled configured to receive a sensor signal and calculate resistance of the blood vessel as a function of blood flow within the blood vessel and aortic pressure (Fig. 36C block 636 and [0180]).
Regarding claim 37, Franano et al. ‘559 teaches wherein the system further comprises a motor ([0100]; “motor of the blood pump 25”), and wherein the controller is configured to:
detect a change in resistance of impeller rotation (Fig. 36B blocks 614, 616 and [0025], [0036], [0178]);
maintain a constant impeller rotational speed, based on the detected resistance of impeller rotation ([0024]-[0025]); and
transmit pump operation data to a non-transient computing device (Fig. 36A blocks 614, 616 and [0178]).
Regarding claim 38, Franano et al. ‘559 teaches wherein the pump operation data includes at least one of: pressure measurement (Fig. 36C block 634 and [0027], [0154], [0180]), current measurement, change in resistance of impeller rotation, and flow estimation (Fig. 36A block 604 and [0178]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Franano et al. ‘559 in view of Hatib et al. ‘481 (US Pub No. 2005/0187481 – previously cited).
Regarding claim 39, Franano et al. ‘559 teaches all of the elements of the current invention as mentioned above except for wherein the controller is configured to:
receive a first aortic pressure corresponding to a first time and a second aortic pressure measurement corresponding to a second time, wherein the first time and the second time occur during a diastolic fall of a heartbeat;
determine a first rate of blood flow pumped by the blood pump at the first time and a second rate of blood flow pumped by the blood pump at the second time; and
calculate, using (i) the first aortic pressure measurement, (ii) the second aortic pressure measurement, (iii) the first rate of blood flow, and (iv) the second rate of blood flow, systemic vascular resistance and compliance using a time dependent non-linear model of a vascular system.
Hatib et al. ‘481 teaches most known blood-pressure-based systems rely on the so-called pulse contour method (PCM), which calculates an estimate of the cardiac parameter(s) of interest from characteristics of the beat-to-beat pressure waveform. In the PCM, "Windkessel" (German for "air chamber") parameters (characteristic impedance of the aorta, compliance, and total peripheral resistance) are typically used to construct a linear or non-linear, hemodynamic model of the aorta. In essence, blood flow is analogized to a flow of electrical current in a circuit in which an impedance is in series with a parallel-connected resistance and capacitance (compliance). The Windkessel circuit model is used to determine cardiac output ([0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Franano et al. ‘559 to include receiving a first aortic pressure corresponding to a first time and a second aortic pressure measurement corresponding to a second time, wherein the first time and the second time occur during a diastolic fall of a heartbeat; determining a first rate of blood flow pumped by the blood pump at the first time and a second rate of blood flow pumped by the blood pump at the second time; and calculating, using (i) the first aortic pressure measurement, (ii) the second aortic pressure measurement, (iii) the first rate of blood flow, and (iv) the second rate of blood flow, systemic vascular resistance and compliance using a time dependent non-linear model of a vascular system as Hatib et al. ‘481 teaches that this is well-known in the art.
Regarding claim 40, Franano et al. ‘559 in view of Hatib et al. ‘481 teaches wherein the time dependent non-linear model is a Windkessel model ([0017] of Hatib et al. ‘481).
Regarding claim 41, Franano et al. ‘559 in view of Hatib et al. ‘481 teaches wherein the controller is further configured to determine cardiac output based on the first aortic pressure measurement, the second aortic pressure measurement, the first rate of blood flow, and the second rate of blood flow ([0017] of Hatib et al. ‘481).
Regarding claim 42, Franano et al. ‘559 teaches wherein the controller is configured to receive pump operation commands from the non-transient computing device, wherein the pump operation commands are based on the pump operation data (Fig. 36A blocks 614, 616 and [0178]).
Response to Arguments
Applicant argues that the claims do not recite Abstract Ideas. Examiner respectfully disagrees, as the detecting step could be merely a user reviewing data on a computer and “detecting” a change in the hemodynamic parameter. Furthermore, the detecting step could also be interpreted as pre-solutional activity of data gathering.
Applicant argues that the claim recites additional elements that integrate the judicial exception into a practical application. Examiner respectfully disagrees, as claim 36 merely recites collecting data (change in hemodynamic parameter) to calculate resistance of the blood vessel. Applicant argues that this is to achieve the induced blood flow. However, claim 36 merely recites calculating a data point. There is no recitation of any transformation or change to the system. Thus, the claim merely recites Abstract Ideas.
Applicant argues that there is an integral relationship between the system for inducing blood flow and the hemodynamic sensor. However, there is no recitation in the claim that the collected data from the sensor would induce blood flow. Claim 36 merely recites calculating a data point (resistance of the blood flow) and does not mention how the calculated resistance would induce blood flow. Furthermore, the structural components recited in the claims are well-understood, routine, and conventional (WURC), as seen in Franano et al. ‘559. Thus, Applicant’s arguments are not persuasive and the 35 U.S.C. 101 rejection have been maintained.
Applicant argues that Franano et al. ‘559 fails to teach “the system including an impeller configured to be rotated within the patient’s blood vessel.” However, [0051] of the PGPUB reads “an impeller blade on the drive shaft may be rotated within a pump housing 134 to induce a flow of blood into the cannula 173 at a suction head 174,” indicating that the impeller is within the pump housing, not the blood vessel. As such, the claims are interpreted as “an impeller configured to be rotating the patient’s blood.” Although Fig. 1 does show the pump housing 134 within the blood vessel, the claim does not accurately recite this. Examiner suggests to amend the limitation to properly read where the impeller is located on the system to potentially overcome this rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) 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 AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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