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 1, 2, 4-7, 15-25 are currently pending. Claims 15-25 remain withdrawn. Claims 3 and 14 have been cancelled. Claims 1, 2, 4, and 5 have been amended to overcome the claim objections set forth in the Non-Final Office Action mailed on 20 August 2025.
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, 2, and 4-7 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 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including receiving, from the pressure transducer, the peripheral venous pressure (PVP) waveform from the patient. Thus, the claim is directed to a process, 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 cleaning the PVP waveform and transforming the PVP waveform into a frequency domain 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. These steps also describe a concept of organizing human activity (including fundamental economic principles or practices, commercial or legal interactions, managing personal behavior or relationships or interactions between people). Thus, the claim is drawn to Organizing Human Activity, 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 1 recites automatically predicting a hemodynamic state of the patient, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The prediction of the hemodynamic state of the patient 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 predicted hemodynamic state of the patient, 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 acquiring a peripheral venous pressure (PVP) waveform of the patient using a peripheral intravenous catheter linked to a pressure transducer, wherein the patient is a pediatric patient and receiving, from the pressure transducer, the PVP waveform from the patient. Acquiring and receiving data are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the acquiring and receiving steps are each 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 do 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.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2 and 5 recite steps that add to the Abstract Idea as these claims recite mental processing steps. Claim 4 recites a measuring step that is pre-solutional data gathering and a determining step which is a mental process. Claims 6 and 7 recite additional elements that are not significantly more. 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 § 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.
Claims 1, 2, and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Eagle et al. ‘959 (US Pub No. 2016/0073959 – cited by Applicant) in view of Kiani ‘691 (US Pub No. 2006/0058691 – previously cited).
Regarding claim 1, Eagle et al. ‘959 teaches a method of predicting a hemodynamic state of a patient being administered an anesthetic (Abstract, [0011]), the method comprising:
acquiring a peripheral venous pressure (PVP) waveform of the a patient using a peripheral intravenous catheter linked to a pressure transducer ([0011]; “…a pressure transducer is used to be directly connected to the peripheral IV catheter, and the peripheral venous signals are captured and recorded by the pressure transducer.”);
receiving, from the pressure transducer, the peripheral venous pressure (PVP) waveform from the patient (Fig. 2 step S210 and [0083));
cleaning the PVP waveform ([0128]; “To minimize signal noise, data was captured during periods of minimal patient movement and no electrocautery use.”);
transforming the PVP waveform into a frequency domain (Fig. 2 step S220 and [0083], [0128)); and
automatically predicting a hemodynamic state of the patient (Fig. 2 step S250 and [0083]; Hypovolemia and hypervolemia are hemodynamic states, as supported by [0010] of the filed specification of the current application.).
Eagle et al. ‘959 teaches all of the elements of the current invention as mentioned above except for wherein the patient is a pediatric patient.
Kiani ‘691 teaches a patient type can be an adult, pediatric, or neonate ([0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pediatric patient of Kiani ‘691 for the adult patient of Eagle et al. ‘959 as Kiani ‘691 teaches that simple substitution of known element for another would obtain predictable results.
Regarding claim 2, Eagle et al. ‘959 teaches wherein the hemodynamic state is automatically predicted using a k-nearest neighbor (k-NN), neural network ([0035]), random forest, support vector machine (SVM), naïve Bayes, and/or K-Means model.
Regarding claim 4, Eagle et al. ‘959 teaches measuring the patient’s electrocardiography (ECG) ([0125]) and determining ECG and PVP waveform coefficients ([0008], [0013]; “plurality of peaks”) at heart rate and respiratory rate ([0013]; The first frequency F0 and second frequency F1 are associated with a respiratory rate of the living subject and a heart rate of the living subject, respectively.).
Regarding claim 5, to best to the Examiner’s understanding, Eagle et al. ‘959 teaches wherein cleaning the PVP waveform comprises:
sectioning the PVP waveform at a pre-selected length of time to create one or more segments ([0084]; “…for a time period from T.sub.0 to T.sub.2, the time period may be divided into a first time period from T.sub.0 to T.sub.1…”);
calculating a remainder of the PVP waveform divided by the pre-selected length of time ([0084]; “…the time period may be divided into more than two time periods, and multiple sets of peripheral venous pressure frequency spectrums may be obtained.”);
removing any last points of the PVP waveform that are equal to the remainder of the PVP waveform ([0084]; “…the peripheral venous pressure frequency spectrum obtained at an earlier time may be used as a baseline peripheral venous pressure frequency spectrum.”);
calculating a mean and a standard deviation for each segment of the one or more segments; and
removing a segment if there is at least one point outside a set number of standard deviations selected by a user ([0083]; “…the processing device 120 performs a statistical analysis on amplitudes of peaks of the peripheral venous pressure frequency spectrum to determine the blood volume status of the living subject in real time…”).
Regarding claim 6, Eagle et al. ‘959 teaches wherein the hemodynamic state is a hypervolemic state, an euvolemic state, or a hypovolemic state (Fig. 2 step S250 and [0083], [0086]).
Regarding claim 7, Eagle et al. ‘959 teaches wherein the anesthetic is an infused anesthetic, and wherein the infused anesthetic is:
an infused GABA agonist selected from propofol, etomidate, and benzodiazepines ([0124]);
an infused narcotic selected from fentanyl, remifentanil, sufentanyl, morphine, and hydromorphone;
an infused barbiturate selected from phenobarbital, pentobarbital, and methohexital;
an infused NMDA antagonist selected from ketamine and esketamine ([0104]);
an infused alpha agonist such as precedex; or
an infused neuraxial anesthetic selected from lidocaine, bupivacaine, ropivacaine, tetracaine, chloroprocaine, clonidine, fentanyl, hydromorphone, morphine, epinephrine, sodium bicarbonate, and glucocorticoids.
Response to Arguments
Applicant’s arguments with respect to the 35 U.S.C. 112(a) and 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(a) and 35 U.S.C. 112(b) rejections of claim 5 has been withdrawn.
Applicant argues that the acquiring step and the receiving step mentioned in claim 1 cannot be performed mentally or by hand. Examiner respectfully disagrees, as the acquiring step could merely be a user reviewing waveform data on a computer and mentally acquiring the data. The receiving step could also be a user receiving the PVP waveform and mentally receiving the data. It is noted that the acquiring and receiving steps both mention a structural element that performs these steps, peripheral intravenous catheter linked to a pressure transducer and the pressure transducer, respectively. It is noted that 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. It is also further noted that the acquiring and receiving steps are also analyzed in Step 2B of the 101 analysis as these steps are also pre-solution activities of data gathering.
Applicant argues that claim 1 provides a technological improvement. However, claim 1 merely recites generic data gathering (acquiring and receiving steps) which are then analyzed (cleaning and transforming steps) to output a data point (predicting step). It is unclear how automatically predicting a hemodynamic state provides a technological improvement. It is also noted that the only structural elements received are the peripheral intravenous catheter linked to a pressure transducer and the pressure transducer, which are known in the art, as supported by [0007] of Farazi et al. ‘155 (US Pub No. 2010/0057155).
Regarding Applicant’s arguments with CardioNet, LLC v. InfoBionic, Inc., it is noted that the only “analyzing” steps mentioned in claim 1 are the cleaning and transforming steps. However, these are considered mental processes or steps of organizing human activity as these steps could merely be a user removing outlier data and transforming the waveform using a mathematical equation. It is noted that section 2106.05(a) II. of the MPEP states that “…it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.”
Applicant argues that claim 1 recites a practical application. However, it is unclear how automatically predicting a hemodynamic state provides a technological improvement as this step is merely an output of a data point.
Applicant argues that claim 1 recites an integral use of a peripheral intravenous catheter linked to a pressure transducer as it “play[s] a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly.” However, the peripheral intravenous catheter and pressure transducer are well-known in the art, as supported by Farazi et al. ‘155. Furthermore, the peripheral intravenous catheter and pressure transducer are generic computer devices used to perform the Abstract Idea and perform pre-solution data gathering activity. 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. As such, Applicant’s arguments regarding the 35 U.S.C. 101 rejection are not persuasive and the 35 U.S.C. 101 rejection has been maintained.
Applicant argues that Kiani ‘691 cannot be used to teach “wherein the patient is a pediatric patient” because Kiani ‘691 teaches plethysmographic wave respiratory variation. However, Kiani ‘691 is not used to change the type of monitoring. Rather, Kiani ‘691 is used to teach what kind of patient that is being monitored is. As previously mentioned, Kiani ‘691 teaches that the patient may be an adult, pediatric, or neonate ([0021]). Eagle et al. ‘959 monitors only adult patients ([0004], [0130]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pediatric patient of Kiani ‘691 for the adult patient of Eagle et al. ‘959 as Kiani ‘691 teaches that adult, pediatric, or neonate patients can be monitored ([0021]), which is simple substitution of known element for another would obtain predictable results. As such, Applicant’s arguments are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791