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 § 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 1-15 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 analyzing one or more physiological parameters of an organism. 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:
analyzing one or more physiological parameters of an organism;
based on the analyzing, causing a graphical user interface (GUI) to be rendered on a display;
providing a visualization of a relationship between said physiological parameters in each of the quadrants; and
causing each of the quadrants to share an axis by which the ordinate or abscissa of a respective quadrant forms the abscissa or ordinate of an adjacent quadrant.
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion) and/or organizing human activity. Thus, the claim is drawn to a Mental Process and Organizing Human Activity, which are Abstract Ideas.
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 conveying oxygenation of the organism visually in the GUI as a graphical element that extends through the four quadrants in a cycle by intersecting each abscissa or ordinate of the four quadrants at a position corresponding to a value of the respective physical parameter, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The conveying oxygenation 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 conveyed oxygenation, 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 elements of wherein the GUI includes four quadrants, wherein each of the quadrants includes an abscissa and an ordinate as respective axes which each represent at least one of the physiological parameters.
The GUI with an abscissa and ordinate are well-understood, routine and conventional for those in the field of medical diagnostics (see art rejection below). 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)).
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, 4, and 9 recite steps that add to the Abstract Idea. Claim 3 recites pre-solutional data gathering activity. Claims 5-7 and 10-13 recite WURC displaying on a GUI. Claim 8 recites a conveying step that does not provide an improvement. 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, 2, 4, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freeman et al. ‘079 (US Pub No. 2007/0016079).
Regarding claim 1, Freeman et al. ‘079 teaches a method for patient monitoring implemented using one or more processors (Abstract), comprising:
analyzing one or more physiological parameters of an organism ([0085]; “…the tissue can be monitored…”);
based on the analyzing, causing a graphical user interface (GUI) to be rendered on a display, wherein the GUI includes four quadrants, wherein each of the quadrants includes an abscissa and an ordinate as respective axes which each represent at least one of the physiological parameters (Fig. 3 and [0129]), wherein the causing includes:
providing a visualization of a relationship between said physiological parameters in each of the quadrants (Fig. 3 shows the relationship between oxy hemoglobin coefficients and deoxy hemoglobin coefficients.), and
causing each of the quadrants to share an axis by which the ordinate or abscissa of a respective quadrant forms the abscissa or ordinate of an adjacent quadrant (Fig. 3 shows an abscissa, x and y axes, that form four quadrants.);
conveying oxygenation of the organism visually in the GUI as a graphical element that extends through the four quadrants in a cycle by intersecting each abscissa or ordinate of the four quadrants at a position corresponding to a value of the respective physical parameter ([0129]; “By measuring an MHSI where the oxyhemoglobin component is high and the deoxyhemoglobin component is low (upper left hand corner of FIG. 3), it could be concluded that that particular area of tissue has adequate perfusion and oxygenation, and is able to satisfy its metabolic needs with the oxygen that is being delivered. That this tissue has the lowest level of risk for ulceration and the highest probability of healing. If tissue demonstrates a low oxyhemoglobin level in addition to a low deoxyhemoglobin level (lower left corner of FIG. 3), this would imply that the tissue was receiving low total volume of blood. If tissue demonstrates a low oxyhemoglobin level in addition to a high deoxyhemoglobin level (lower right corner of FIG. 3) this would imply that the tissue has metabolic requirements exceeding available oxygen delivery. In both of these regions there is expected to be a higher risk of ulceration or difficulties with wound healing. If the tissue has a high oxyhemoglobin coefficient and also has a high deoxyhemoglobin content, (lower left corner of FIG. 3) this tissue was receiving a larger total volume of blood, and that the oxygen extracted from the blood stream was adequate to support tissue metabolism. This could be indicative of inflammation.”).
Regarding claim 2, Freeman et al. ‘079 teaches for at least one of the physiological parameters which is represented in a quadrant, receiving an input of a user-selected value for the physiological parameter (The oxy hemoglobin coefficients and deoxy hemoglobin coefficients are represented in the four quadrants.); and
causing a further graphical element to be rendered which crosses the abscissa or ordinate of the quadrant at the user-selected value and which extends through the four quadrants in accordance with the relationships visualized in the quadrants ([0129]; “By measuring an MHSI where the oxyhemoglobin component is high and the deoxyhemoglobin component is low (upper left hand corner of FIG. 3), it could be concluded that that particular area of tissue has adequate perfusion and oxygenation, and is able to satisfy its metabolic needs with the oxygen that is being delivered. That this tissue has the lowest level of risk for ulceration and the highest probability of healing. If tissue demonstrates a low oxyhemoglobin level in addition to a low deoxyhemoglobin level (lower left corner of FIG. 3), this would imply that the tissue was receiving low total volume of blood. If tissue demonstrates a low oxyhemoglobin level in addition to a high deoxyhemoglobin level (lower right corner of FIG. 3) this would imply that the tissue has metabolic requirements exceeding available oxygen delivery. In both of these regions there is expected to be a higher risk of ulceration or difficulties with wound healing. If the tissue has a high oxyhemoglobin coefficient and also has a high deoxyhemoglobin content, (lower left corner of FIG. 3) this tissue was receiving a larger total volume of blood, and that the oxygen extracted from the blood stream was adequate to support tissue metabolism. This could be indicative of inflammation.”).
Regarding claim 4, Freeman et al. ‘079 teaches controlling an oxygen supplementation of the organism based on the user-selected value for the physiological parameter ([0085]; “In the case of hyperbaric oxygen therapy, the tissue can be monitored before and at specified intervals during therapy or continuously during therapy to determine when the tissue has been adequately modified (oxygenated) by the therapy or that there has been sufficient change in tissue metabolism as described by the MHSI measurements of oxyHb, deoxyHb or other measured parameters or whether no benefit is being delivered”).
Regarding claim 14, Freeman et al. ‘079 teaches a system for patient monitoring comprising one or more processors and memory storing instructions that, in response to execution of the instructions by the one or more processors, cause the one or more processors to: perform the claimed steps, as the subject matter of claim 14 is analogous to the subject matter of claim 1.
Regarding claim 15, Freeman et al. ‘079 teaches at least one non-transitory computer-readable medium comprising instructions that, in response to execution of the instructions by one or more processors, cause the one or more processors to perform the method of claim 1 ([0020]).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. ‘079 in view of Wells ‘195 (US Pub No. 2007/0234195).
Regarding claim 3, Freeman et al. ‘079 teaches all of the elements of the current invention as mentioned above except for wherein the input of the user-selected value is obtained by incremental adjustment of an initial user-selected value and wherein the further graphical element is updated after each incremental adjustment.
Wells ‘195 teaches a user may be able to interactively select zoom regions and interactively edit axis ranges, and the graph's appearance may be updated in response to the user's actions ([0066]).
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 input of the user-selected value of Freeman eta l. ‘079 to include being obtained by incremental adjustment of an initial user-selected value and wherein the further graphical element is updated after each incremental adjustment as Wells ‘195 teaches that this will aid in the user being able to interactively zoom into regions of the graph.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. ‘079 in view of Vairavan et al. ‘470 (US Pub No. 2018/0071470).
Regarding claim 6, Freeman et al. ‘079 teaches all of the elements of the current invention as mentioned above except for wherein in a first quadrant of the four quadrants that conveys information about lung function in the organism, the abscissa corresponds to fractional oxygen concentration (FiO2) of the organism and the ordinate corresponds to partial pressure of arterial oxygen (PaO2) of the organism.
Vairavan et al. ‘470 teaches displaying trend data for various physiological variables of a patient, which include fraction of inspired oxygen (FiO2) and partial pressure of oxygen in arterial blood (PaO2) (Fig. 3 and [0020]).
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 first quadrant of Freeman et al. ’079 to include conveying information about lung function in the organism, the abscissa corresponds to fractional oxygen concentration (FiO2) of the organism and the ordinate corresponds to partial pressure of arterial oxygen (PaO2) of the organism as Vairavan et al. ‘470 teaches that this would aid in indicating ARDS ([0024]).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. ‘079 in view of Vairavan et al. ‘470 further in view of Conroy Jr. ‘009 (US Pub No. 2007/0271009).
Regarding claims 7 and 8, Freeman et al. ‘079 in view of Vairavan et al. ‘470 teaches all of the elements of the current invention as mentioned above except for wherein in a second quadrant of the four quadrants that conveys information about gas transfer in the organism, the abscissa corresponds to PaO2 of the organism and the ordinate corresponds to hemoglobin oxygen saturation (SaO2) of the organism; and
visually conveying the relationship between PaO2 values of the abscissa and SaO2 value of the ordinate by causing an oxygen-hemoglobin dissociation curve to be rendered in the second quadrant.
Conroy Jr. ‘009 teaches plotting oxygen pressure torr versus oxygen saturation with a hemoglobin saturation curve, also referred as the oxygen disassociation curve (ODC), also referred as the hemoglobin disassociation curve (Fig. 1 and [0039]).
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 second quadrant of Freeman et al. ‘079 in view of Vairavan et al. ‘470 to include conveying information about gas transfer in the organism, the abscissa corresponds to PaO2 of the organism and the ordinate corresponds to hemoglobin oxygen saturation (SaO2) of the organism; and visually conveying the relationship between PaO2values of the abscissa and SaO2value of the ordinate by causing an oxygen-hemoglobin dissociation curve to be rendered in the second quadrant as Conroy Jr. ‘009 teaches that while many factors may significantly affect the human body's ability to process oxygen at a given moment even for the same individual, especially in a reduced oxygen environment, it is possible to measure the effects objectively against well known clinical standards for an increased risk of hypoxemia ([0055]).
Regarding claim 9, Freeman et al. ‘079 in view of Vairavan et al. ‘470 further in view of Conroy Jr. ‘009 teaches all of the elements of the current invention as mentioned above except for rendering one or more additional visual annotations that convey one or more additional parameters that influence a portion of the oxygen-hemoglobin dissociation curve.
Conroy Jr. ‘009 teaches that ODC is affected by temperature, pH, hemoglobin value, 2-3-DPG, and ambient temperature and pressure (ATP) levels. These factors all affect erythrocytic functions and compensate for variation in body homostasis. In hyperventilation, the increased flow of oxygen results in acidic blood serum levels (lower pH), higher body temperature and higher 2-3-DPG environments. Corresponding oxygen unloading results in alkaline blood serum levels (higher pH), lower body temperature, and lower 2-3-DPG levels. A decrease in hemoglobin would decrease the overall ODC curve ([0039]). The curve of the ODC is affected by temperature, pH, hemoglobin value, 2-3-DPG, and ambient temperature and pressure (ATP) levels.
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 Freeman et al. ‘079 in view of Vairavan et al. ‘470 further in view of Conroy Jr. ‘009 to include rendering one or more additional visual annotations that convey one or more additional parameters that influence a portion of the oxygen-hemoglobin dissociation curve as Conroy Jr. ‘009 teaches that that while many factors may significantly affect the human body's ability to process oxygen at a given moment even for the same individual, especially in a reduced oxygen environment, it is possible to measure the effects objectively against well known clinical standards for an increased risk of hypoxemia ([0055]).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. ‘079 in view of Vairavan et al. ‘470 further in view of Conroy Jr. ‘009 further in view of Scholler et al. ‘693 (US Pub No. 2007/0167693).
Regarding claim 10, Freeman et al. ‘079 in view of Vairavan et al. ‘470 further in view of Conroy Jr. ‘009 teaches all of the elements of the current invention as mentioned above except for wherein in a third quadrant of the four quadrants that conveys information about blood of the organism, the abscissa corresponds to SaO2 of the organism and the ordinate corresponds to arterial oxygen content (CaO2) of the organism.
Scholler et al. ‘693 teaches the dependence of CaO2, SaO2, and cHb. The boundary regions for CaO2 are at the points where the organism starts to change over to anaerobic metabolism in the periphery and where the hypoxia reaches the critical range. When CaO2 is cut in half in the acute situation, the patient will in all likelihood still be in the safe range, provided that all other organs are healthy. In a hypoxemia-adapted patient who is otherwise healthy, the critical value is one-third of the normal value (Fig. 2 and [0049]).
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 third quadrant of Freeman et al. ‘079 in view of Vairavan et al. ‘470 further in view of Conroy Jr. ‘009 to include conveying information about blood of the organism, the abscissa corresponds to SaO2 of the organism and the ordinate corresponds to arterial oxygen content (CaO2) of the organism as Scholler et al. ‘693 teaches that this will aid in monitoring change over to anaerobic metabolism where hypoxia reaches a critical range.
Regarding claim 11, Freeman et al. ‘079 in view of Vairan et al. ‘470 further in view of Conroy Jr. ‘009 further in view of Scholler et al. ‘693 teaches all of the elements of the current invention as mentioned above except for wherein a width of the graphical element that extends from the second quadrant to the third quadrant is dictated by an intersection of the graphical element with the oxygen-hemoglobin dissociation curve.
Because Conroy Jr. ‘009 teaches plotting PaO2 values and SaO2 values and Scholler et al. ‘693 teaches plotting CaO1 and SaO2, 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 second and third quadrants of Freeman et al. ‘079 to be dictated by an intersection of the graphical element with the oxygen-hemoglobin dissociation curve as both Conroy Jr. ‘009 and Scholler et al. ‘693 both teach plotting similar values (SaO2).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. ‘079 in view of Vairavan et al. ‘470 further in view of Conroy Jr. ‘009 further in view of Scholler et al. ‘693 further in view of McCall et al. ‘386 (US Pub No. 2018/0228386).
Regarding claim 12, Freeman et al. ‘079 in view of Vairavan et al. ‘470 further in view of Conroy Jr. ‘009 further in view of Scholler et al. ‘693 teaches all of the elements of the current invention as mentioned above except for wherein in a fourth quadrant of the four quadrants that conveys information about cardiac output of the organism, the abscissa corresponds to CaO2 of the organism and the ordinate corresponds to oxygen delivery (DO2) of the organism.
McCall et al. ‘386 teaches that cardiac output, arterial oxygen content CaO2, and oxygen delivery DO2 ([0053]) are hemodynamic parameters that could be depicted on the graph 910 (Fig. 9 and [0094]).
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 fourth quadrant of Freeman et al. ‘079 in view of Vairavan et al. ‘470 further in view of Conroy Jr. ‘009 further in view of Scholler et al. ‘693 to include conveying information about cardiac output of the organism, the abscissa corresponds to CaO2 of the organism and the ordinate corresponds to oxygen delivery (DO2) of the organism as McCall et al. ‘386 teaches that this would aid in displaying hemodynamic parameters obtained through minimally invasive techniques that are calibrated to more accurate measurements obtained using invasive techniques ([0046]).
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