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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 20 May 2026 has been entered.
Response to Amendment
Claims 1, 2, 4-7, and 15-25 are currently pending. Claims 15-25 remain withdrawn. Claim 1 has been amended.
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:
establishing an anesthetic depth;
cleaning the PVP waveform;
transforming the PVP waveform into a frequency domain;
automatically predicting a hemodynamic state of the patient; and
adjusting a dosage of the anesthetic based on the hemodynamic state of the patient and the anesthetic depth
set forth a judicial exception. The establishing, transforming, and automatically predicting 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. The cleaning and transforming steps describe a concept related to mathematical relationships, mathematical formulas or equations, mathematical calculations . Thus, the claim is drawn to Mathematical Processes, which is also an Abstract Idea. The adjusting step describes 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 also 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 adjusting a dosage of the anesthetic based on the hemodynamic state of the patient and the anesthetic depth, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The adjusting of the dosage 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 adjusted dosage, 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)).
It is also noted that the peripheral intravenous catheter and pressure transducer are well-understood, routine, and conventional (WURC), as supported by [0014] of Scheurer et al. ‘398 (US Pub No. 2010/0076398).
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 – previously cited) in view of Kiani ‘691 (US Pub No. 2006/0058691 – previously cited) further in view of Hirsh ‘582 (US Pub No. 2003/0083582).
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:
establishing an anesthetic depth ([0080]; “…may be induced with anesthesia such that the patient is not spontaneously moving” It is noted that the anesthetic depth is interpreted as enough anesthesia so that the patient is “not spontaneously moving.”);
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.
Eagle et al. ‘959 in view of Kiani ‘691 teaches all of the elements of the current invention as mentioned above except for adjusting a dosage of the anesthetic based on the hemodynamic state of the patient and the anesthetic depth.
Hirsh ‘582 teaches a real-time hemodynamic data stream is used to control vasoactive infusion pumps and the level of anesthesia itself via an appropriate computer program. This allows the frequent adjustments of cardiac medications without the need for a patient visit. By allowing frequent and rapid dosage adjustments, the system prevents patients with congestive heart failure from being hospitalized for an acute decompensation ([0126]).
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 method of Eagle et al. ‘969 in view of Kiani ‘691 to include adjusting a dosage of the anesthetic based on the hemodynamic state of the patient and the anesthetic depth as Hirsh ‘582 teaches that this will aid in preventing patients with congestive heart failure from being hospitalized for an acute decompensation.
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 argues that the acquiring and receiving steps in claim 1 are not Abstract Ideas. However, these steps are seen as pre-solution steps of data gathering necessary to perform the Abstract Idea. Furthermore, it is noted that the peripheral intravenous catheter and pressure transducer are WURC, as supported by Scheurer et al. ‘398. Examiner suggest to amend claim 1 to include what structures perform each step, as previously mentioned in the Interview conducted on 14 May 2026.
Applicant argues that the amended claim 1 now recites a transformation. Examiner respectfully disagrees, as the adjusting step is seen as an Abstract Idea. 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.” Examiner suggests to amend claim 1 to further recite that the anesthetic is first being administered then adjusted based on the cleaning, transforming, and predicting steps. As such, Applicant’s arguments are not persuasive and the 35 U.S.C. 101 rejection has been maintained.
Applicant’s arguments with respect to the 35 U.S.C. 103 rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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
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