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 .
Election/Restrictions
Applicant’s election of claims 36-42 in the reply filed on 18 August 2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 24-35 have been withdrawn. Claims 46-51 have been added.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “computing device” in claims 37 and 42.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“Computing device” is interpreted as “a server,” as mentioned in [0032] of the PGPUB. However, it is unclear if “server” should be rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. Examiner suggests to amend the limitation to read as “non-transient computing device.”
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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.
Claim 39 is 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. Claims 40-42 are further rejected due to their dependency to claim 39.
Claim 39 recites “calculate…a time dependent non-linear model of a vascular system to determine systemic vascular resistance and compliance” in lines 8-11. It is unclear what it means to “calculate a model.” It is unclear if lines 8-11 should recite “calculate...systemic vascular resistance and compliance using a time dependent non-linear model of a vascular system.” Clarification is requested.
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 claim 36 follows.
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 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 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).
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]);
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 comprises a motor ([0100]; “motor of the blood pump 25”) and an impeller ([0100]; “impeller of the pump”), 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 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).
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, a time dependent non-linear model of a vascular system to determine systemic vascular resistance and compliance.
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, a time dependent non-linear model of a vascular system to determine systemic vascular resistance and compliance 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 computing device, wherein the pump operation commands are based on the pump operation data (Fig. 36A blocks 614, 616 and [0178]).
Conclusion
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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/AURELIE H TU/ Primary Examiner, Art Unit 3791