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 .
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.
Claims 1 and 12 are 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 2-11 and 13-20 are further rejected due to their dependency to claim 1 or 12.
The term “near” in claims 1 and 12 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what range/distance “near” encompasses. Thus, it is unclear what it means for the sensor to be “near” a tip of the tubular body. Fig. 16 and [0065] of the PGPUB of the current application states that the sensor 1615 is on a body 1602, which is not on the tip 1604. For examination purposes, “at least one sensor near a tip of the tubular body” is interpreted as the at least one sensor being on a device, the device including the tip.
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 1-20 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 structural elements, including a device. 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:
process the PVP waveform; and
determine a hemodynamic state of the patient based on the processed PVP waveform
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 1 recites at least one processor configured to determine a hemodynamic state of the patient based on the processed PVP waveform, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The determining of the hemodynamic state 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 determined hemodynamic state, 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 additional steps of: at least one processor receiving the PVP waveform from the at least one sensor. The receiving step is a well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the receiving 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 and comparing 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 and comparing steps 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)).
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited at least one sensor is configured to perform pre-solutional data gathering activity and the at least one processor is 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 recited device comprising a tubular body comprising a first lumen operable to deliver a fluid; and at least one sensor near a tip of the tubular body, and the at least one processor are also additional elements that are not significantly more as the recited device is well-understood, routine, and conventional, as supported by [0106] and [0126] of Eagle et al. ‘959 (US Pub No. 2016/0073959 – cited by Applicant).
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 same rationale applies to claim 12.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2-5 and 19 recite steps that add to the Abstract Idea as these claims recite mental processing and/or mathematical steps. Claims 6-10 and 13-18 recite additional elements which do not add anything significantly more. Claims 11 and 20 recite steps that are directed to pre-solutional activity of data gathering. 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 1, 3, 4, 6, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eagle et al. ‘959 (US Pub No. 2016/0073959 – cited by Applicant).
Regarding claim 1, Eagle et al. ‘959 teaches a system for analyzing one or more conditions of a patient (Title, Abstract), the system comprising:
a device (Fig. 1 peripheral IV device 110 and [0079]) comprising:
a tubular body comprising a first lumen operable to deliver a fluid ([0080]; “peripheral IV catheter”); and
at least one sensor ([0080]; “pressure transducer”) near a tip of the tubular body (To best to the Examiner’s understanding in accordance to the 35 U.S.C. 112(b) rejection, the peripheral IV device includes the peripheral IV catheter and the monitoring device, the monitoring device including the pressure transducer. Because all components are part of the peripheral IV device, the pressure transducer is “near” the tip of the tubular body.), the at least one sensor configured to measure one or more characteristics of a peripheral venous pressure (PVP) waveform within a vein of the patient ([0080]; “peripheral venous signals”); and
at least one processor (Fig. 1 processing device 120 and [0079]) configured to:
receive the PVP waveform from the at least one sensor (Fig. 2 step S210 and [0083]);
process the PVP waveform (Fig. 2 step S230 and [0083]); and
determine a hemodynamic state of the patient based on the processed PVP waveform (Fig. 2 step S250 and [0083]).
Regarding claim 3, Eagle et al. ‘959 teaches wherein processing the PVP waveform includes cleaning the PVP waveform ([0128]; “To minimize signal noise, data was captured during periods of minimal patient movement and no electrocautery use.”).
Regarding claim 4, 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 device is configured to couple to a fluid infusion system ([0082]; “infusion pump”).
Regarding claim 12, Eagle et al. ‘959 teaches a device for analyzing one or more conditions of a patient (Title, Abstract), the device comprising:
a tubular body comprising a first lumen, wherein the first lumen is operable to deliver a fluid ([0080]; “peripheral IV catheter”); and
at least one sensor ([0080]; “pressure transducer”) near a tip of the tubular body (To best to the Examiner’s understanding in accordance to the 35 U.S.C. 112(b) rejection, the peripheral IV device includes the peripheral IV catheter and the monitoring device, the monitoring device including the pressure transducer. Because all components are part of the peripheral IV device, the pressure transducer is “near” the tip of the tubular body.), the at least one sensor configured to measure a peripheral venous pressure within a vein of the patient ([0080]; “peripheral venous signals”); and
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 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Eagle et al. ‘959 in view of Hirsh ‘582 (US Pub No. 2003/0083582 – cited by Applicant).
Regarding claim 2, Eagle et al. ‘959 teaches all of the elements of the current invention as mentioned above except for wherein the at least one processor is further configured to determine a change in the hemodynamic state in response to a micro-dose of fluid delivered to the patient through the first lumen.
Hirsh ‘582 teaches measuring the hemodynamic state of a patient for correctly administering general anesthetic (Abstract, [0006]). One of ordinary skill would understand that administering anesthesia would be delivering small amounts, or micro-doses, of the anesthesia to the patient. 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 ([0125]).
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 at least one processor of Eagle et al. ‘959 to include determining a change in the hemodynamic state in response to a micro-dose of fluid delivered to the patient through the first lumen as Hirsh ‘582 teaches that this will aid in preventing patients with congestive heart failure from being hospitalized for an acute decompensation.
Regarding claim 5, Eagle et al. ‘959 teaches transforming the PVP waveform into a frequency domain (Fig. 2 step S220 and [0083], [0128]).
Claims 8, 10, 14, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Eagle et al. ‘959 in view of Miesel ‘624 (US Pub No. 2005/0075624).
Regarding claim 8, Eagle et al. ‘959 teaches all of the elements of the current invention as mentioned above except for a valve in fluid communication with the first lumen.
Miesel ‘624 teaches a check valve 30 in a lumen of catheter 22 (Figs. 10A, 10B and [0051]).
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 system of Eagle et al. ‘959 to include a valve in fluid communication with the first lumen as Miesel ‘624 teaches that this will aid in controlling an output of a pump that is coupled to the catheter ([0051]) to facilitate delivery of a therapeutic substance to the patient ([0003]).
Regarding claim 10, Eagle et al. ‘959 teaches wherein the at least one sensor includes an absolute sensor ([0080]; “pressure transducer”).
Eagle et al. ‘959 teaches all of the elements of the current invention as mentioned above except for wherein the at least one sensor also includes a barometric pressure sensor.
Miesel ‘624 teaches an absolute pressure sensor that senses atmospheric pressure to eliminate the band of pressure uncertainty ([0093]).
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 at least one sensor of Eagle et al. ‘959 to include an absolute sensor and a barometric pressure sensor as Miesel ‘624 teaches that this will aid in eliminating the band of pressure uncertainty.
Regarding claim 14, Eagle et al. ‘959 teaches all of the elements of the current invention as mentioned above except for wherein the at least one sensor includes a vented pressure sensor.
Miesel ‘624 teaches a vent 38 through which a sensor 44 may detect pressure in a body cavity of the patient (Fig. 4 and [0063]).
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 at least one sensor of Eagle et al. ‘959 to include a vented pressure sensor as Miesel ‘624 teaches that this will aid in detecting pressure in the body cavity.
Regarding claim 17, Eagle et al. ‘959 teaches wherein the at least one sensor includes an absolute sensor ([0080]; “pressure transducer”).
Regarding claim 18, Eagle et al. ‘959 teaches all of the elements of the current invention as mentioned above except for wherein the at least one sensor further includes a barometric pressure sensor.
Miesel ‘624 teaches an absolute pressure sensor that senses atmospheric pressure to eliminate the band of pressure uncertainty ([0093]).
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 at least one sensor of Eagle et al. ‘959 to further include a barometric pressure sensor as Miesel ‘624 teaches that this will aid in eliminating the band of pressure uncertainty.
Claims 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Eagle et al. ‘959 in view of Eliasen et al. ‘506 (US Pub No. 2016/0158506).
Regarding claims 7 and 13, Eagle et al. ‘959 teaches all of the elements of the current invention as mentioned above except for wherein the tubular body has a second lumen, wherein the at least one sensor is disposed within the second lumen.
Eliasen et al. ‘506 teaches a catheter 310 with a first lumen 314 and second lumen 316. The first lumen prevents blood flow and the second lumen 316 relays signals, such as pressure (Fig. 3 and [0042]). One of ordinary skill would understand that in order for the pressure signals to be relayed through the second lumen, the pressure sensor would need to be attached to the second lumen.
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 tubular body of Eagle et al. ‘959 to include a second lumen, wherein the at least one sensor is disposed within the second lumen as Eliasen et al. ‘506 teaches that this will aid in delivering cardioplegia fluid, withdrawing fluids such as blood, inserting and/or withdrawing instruments, or relaying signals from various sensors that can be associated with the catheter ([0042]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Eagle et al. ‘959 in view of Jiang et al. ‘339 (US Pub No. 2016/0303339).
Regarding claim 11, Eagle et al. ‘959 teaches all of the elements of the current invention as mentioned above except for wherein the at least one sensor is operable to receive a set of calibration data.
Jiang et al. ‘339 teaches a pressure sensor that is automatically calibrated prior to data collection ([0047]). One of ordinary skill would understand that the pressure sensor receives data to be calibrated.
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 at least one sensor of Eagle et al. ‘959 to include being operable to receive a set of calibration data as Jiang et al. ‘339 teaches that this will aid in being calibrated prior to data collection.
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
