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.
Claim 8 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.
Claim 8 recites “wherein the at least one indicator of blood pressure 8. comprises one or more of subject height, subject weight, subject age, subject gender, subject body position data, subject location measured data, and combinations thereof.” It is unclear if these recited features are in additional options to at least one indicator of claim 2 or, features of heart rate data, physiological data, or something else. Examiner interprets as ---wherein the at least one indicator…further comprises---”
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5, 8-9, 14-15, 17-18, 23, 28, 30, 32-33, 58 rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ripoll [US 20110196244 A1].
As per claim 1, Ripoll teaches an optical patient monitoring system (Ripoll Fig 2) comprising:
an optical coupling system configured to transmit and receive light signals at one or more locations on a subject (Ripoll Fig 2, ¶0051 pulse oximeter for PPG using IR, implies optical coupling system);
an optical processing system configured to generate optical data using the received light signals (Ripoll Fig 2, Fig 4 items for SPO2 processing of step 1); and
a computer programmed to (Ripoll Fig 2, computer / processor required for steps 2-4 and BP estimation. See ¶0103, disclosing a CPU):
receive the optical data; determine, using the optical data, at least one indicator of blood pressure (Ripoll ¶0064-¶0065 “shape and the propagation of the pressure pulse PP. …the preferred implementation of the present invention uses a system of stochastic modeling ARMA (q,p) (Auto-regressive mobile mean model with a q of approximately of q (MA) and p (AR)) (5).” See Fig 5, ¶0070);
estimate an estimated blood pressure using the at least one indicator of blood pressure (Ripoll ¶0091 “Once the features fixed length vector V□n□ is obtained, an estimation of the SBP, DBP and MAP may be performed by the system for approximating functions (3) based on `random forests`.”); and
generate a report indicative of the estimated blood pressure (Ripoll Fig 2 “SBP, DBP, MAP, ¶0103 “The hand device according to the invention may comprise a screen to visualize data and control instructions for the functioning of the apparatus.”. ¶0105 “the obtained results by means of the present invention may be transmitted to a PC to be analyzed”).
As per claim 2, Ripoll further anticipates wherein the at least one indicator of blood pressure comprises one or more of: near-infrared spectroscopy (NIRS) data; photoplethysmography (PPG) data (), diffuse correlation spectroscopy (DCS) data, speckle contrast optical spectroscopy (SCOS) data, speckleplethysmography (SPG) data, first derivative dPPG/dt data, second derivative d2PPG/dt2 data, third derivative d3PPG/dt3 data, first derivative dSPG/dt data, second derivative d2SPG/dt2 data, inflow (F.sub.in) data, outflow (F.sub.out) data, heart rate data, physiological data, and combinations thereof (Examiner chose PPG. Ripoll ¶0041, ¶0044, PPG).
As per claim 3, Ripoll further anticipates wherein the at least one indicator of blood pressure comprises one or more of: photoplethysmography (PPG) data (Ripoll ¶0041, ¶0044, PPG), first derivative dPPGdt data, second derivative d2PPGdt2 data, and third derivative d3PPGdt3 data, and the optical coupling system comprises a light source comprising at least one of an LED or photodiode in a NIRS device, pulse oximeter or cerebral oximeter.
As per claim 5, Ripoll further anticipates wherein the physiological data comprises at least one of electrocardiogram (ECG) data, electroencephalogram (EEG) data, near infrared spectroscopy (NIRS) data, measured blood pressure data, respiratory data, hemoglobin data, pulse oximetry data, tissue oxygenation data, heart rate data, or combinations thereof (This claim is directed to limiting an optional feature, i.e. the physiological data, recited in claim 2. This claim does not have patentable weight in view of option chosen by the examiner. Examiner chose PPG in claim 2, which does not require the recited limitations).
As per claim 8, Ripoll further anticipates wherein the at least one indicator of blood pressure further comprises one or more of subject height, subject weight, subject age, subject gender, subject body position data, subject location measured data, and combinations thereof (Ripoll ¶0081-¶0089).
As per claim 9, Ripoll further anticipates wherein the optical data is acquired over a plurality of cardiac cycles (Ripoll Fig 3, ¶0044-¶0045).
As per claim 14, Ripoll further teaches wherein the computer is configured to apply a machine learning algorithm (Ripoll ¶0033, ¶0042) to estimate the estimated blood pressure by analyzing a measured blood pressure data set against at least one of: near-infrared spectroscopy (NIRS) data, photoplethysmography (PPG) data, diffuse correlation spectroscopy (DCS) data, speckle contrast optical spectroscopy (SCOS) data, speckleplethysmography (SPG) data, first derivative dPPG data, second derivative d²PPG data, first derivative dSPG data, second derivative d²SPG data, inflow (Fin) data, outflow (Fout) data, heart rate data, a ratio of the magnitude of a pre-dicrotic peak (P₂) and a systolic peak (P1), and combinations thereof (Examiner choses PPG. Ripoll ¶0041, ¶0044, PPG).
As per claim 15, Ripoll further anticipates wherein the machine learning algorithm approach is at least one of random forests support vector machines, gaussian process regression, and deep belief networks, and combination thereof
As per claim 17, Ripoll further anticipates wherein the heart rate data comprises instantaneous heart rate data (This claim is directed to limiting an optional feature, i.e. the heart rate data, recited in claim 2. This claim does not have patentable weight in view of option chosen by the examiner. Examiner chose PPG in claim 2, which does not require the recited limitations).
As per claim 18, Ripoll further anticipates wherein the at least one indicator of blood pressure is acquired during a portion of each cardiac cycle (Ripoll Fig 4, step 10-11, ¶0078-¶0079).
As per claim 23, Ripoll further anticipates wherein the light signals have wavelengths between about 300 nm and about 2000 nm (Ripoll ¶0046, infrared).
As per claim 30, 32-33, are directed to method of using system of claims 1-3, and are rejected for same reasons as above.
Claims 1, 6, 10, 12-13, 16, 30, 40, 42 rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sutin [US 20180103861 A1].
As per claims 1, 6, 10, 16, 30, 40, Sutin teaches an optical patient monitoring system (Sutin Fig 6) comprising:
an optical coupling system configured to transmit and receive light signals at one or more locations on a subject (Sutin Fig 6 item 616);
an optical processing system configured to generate optical data using the received light signals (Sutin Fig 6 item 614); and
a computer programmed to (Sutin Fig 6 item 606, ¶0020):
receive the optical data; determine, using the optical data, at least one indicator of blood pressure (Sutin ¶0071 “determine pulsatile information and create accurate measures not achieved or recognized in non-invasive systems previously. By way of example, data, including DCS data,”);
estimate an estimated blood pressure using the at least one indicator of blood pressure (Sutin ¶0074 “In some aspects the controller 610 may be configured to determine a condition of the subject based on determined parameters, such as intracranial pressure,”); and
generate a report indicative of the estimated blood pressure (Sutin ¶0075).
wherein the at least one indicator of blood pressure comprises at least DCS data and NIRS data (Sutin ¶0058), wherein the optical data is acquired at a temporal resolution greater than a pulsatile frequency of the subject (Sutin ¶0020), wherein the one or more locations on a subject comprise the subject's head (Sutin Fig 1), wherein the optical source is coherent, wherein the level of coherence and source output power is determined by the separation of the source and detector (Sutin ¶0103 “cross-spectral coherence and gain analysis” requires coherent source and the level of coherence is inherent property),
As per claims 12-13, 42, Sutin further teaches wherein the computer is configured to estimate the estimated blood pressure by performing a calibration against a measured blood pressure data set (Sutin Fig 6 items 604, 606, 610, 618, ¶0059, ¶0068, utilizing BP from sensors and correlating with DCS data),wherein the measured blood pressure data set is acquired by at least one of continuous measurements, non-continuous measurements invasive (intra-arterial) blood pressure monitoring, non-invasive volume-clamp method, cuff point measurements, automated oscillometry, manual auscultation, and combinations thereof (Sutin ¶0068 “the controller 610 may be configured to acquire simultaneous or synchronous measurements, as well as separate measurements, using various sensors placed on the subject, as described. Also, measurements may be made once, intermittently, periodic, continual, or continuously’)
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 7, 37 rejected under 35 U.S.C. 103 as being obvious over Ripoll as applied to claims 1, 30 above and further in view of Proença [US 20220133165 A1].
As per claims 7, 37 Ripoll does not expressly teach wherein the at least one indicator of blood pressure comprises a ratio of the magnitude of a pre-dicrotic peak (P.sub.2) and a systolic peak (P.sub.1) for at least one individual cardiac cycle in at least one of a PPG curve, a dPPGdt curve, an SPG curve, or a dSPGdt curve.
Proença, in a similar field teaches teach wherein the at least one indicator of blood pressure comprises a ratio of the magnitude of a pre-dicrotic peak (P.sub.2) and a systolic peak (P.sub.1) for at least one individual cardiac cycle in at least one of a PPG curve, a dPPGdt curve (Proença Fig 7, ¶0053 “the amplitude of the diastolic peak A32 of the PPG pulse 23 divided by the amplitude of the systolic peak A33”).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Ripoll by determining and analyzing venous-related features, including different peaks and notches as, as in Proença. Motivation would be to remove motion-related artifacts and other un-wanted components, including venous contribution, from the measured PPG signal (Proença ¶0008).
Claims 4, 24-25, 27, 34 rejected under 35 U.S.C. 103 as being obvious over Ripoll as applied to claims 1, 30 above and further in view of Bechtel [US 20230148885 A1].
As per claim 4, 24-25, 27, 34 Ripoll does not expressly teach wherein the at least one indicator of blood pressure comprises one or more of: speckleplethysmography (SPG) data (Bechtel ¶0060), first derivative dSPG/dt data, and second derivative d2SPG/dt2 data, and the optical coupling system comprises a light source comprising a laser , wherein the optical source is coherent (Bechtel ¶0061 “SPG signals require a coherent laser as light source.”), wherein the level of coherence and source output power is determined by the separation of the source and detector (This is a result / property of arrangement of the source and detector), wherein the light signal is detected by a detector selected from the group comprising single-photon avalanche diodes (SPADs), avalanche photodiodes (APDs), silicon photomultipliers (SiPMs), super conducting nanowire detectors (SNSPDs), photomultiplier tubes (PMTs), high frame rate photodiodes, camera sensors, and combinations thereof (Bechtel ¶0076-¶0077).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Ripoll by integrating SPG measurements as in Bechtel. The motivation would be to simultaneously collect both SPG and PPG signals for the purposes of obtaining HR, HRV, SpO2, and BP accurately (Bechtel ¶0004).
Claim 22 rejected under 35 U.S.C. 103 as being obvious over Ripoll as applied to claims 1, 30 above and further in view of Cho [US 20090024041 A1].
As per claim 22, Ripoll does not expressly teach wherein the light signals are transmitted from an optical source and received by a photodetector that are placed between 1 mm and 40 mm apart.
Cho, in a related fled of measuring bio-information, teaches wherein the light signals are transmitted from an optical source and received by a photodetector that are placed between 1 mm and 40 mm apart (Cho ¶0038 “it is desirable that the distance between the photo detector 210 and the first and second light sources 220 and 230 is set so as to be equal to or shorter than 5 mm”).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Ripoll by integrating distances as in Cho, so as to reduce the influence depending on the thickness of the subcutaneous fat (Cho ¶0038).
Claim 26 rejected under 35 U.S.C. 103 as being obvious over Ripoll as applied to claim 3 above and further in view of Turcott [US 6561984 B1]
As per claim 26, Ripoll does not expressly teach wherein the light signal is detected by a detector selected from the group comprising PIN photodiodes, avalanche photodiodes (APDs), single- photon avalanche diodes (SPADs), photomultiplier tubes (PMTs), silicon photomultipliers (SiPMs), charge-coupled device (CCD), complementary metal-oxide-semiconductor (CMOS) camera sensors, and combinations thereof.
Turcott, in field of plethysmography devices, teaches wherein the light signal is detected by a detector selected from the group comprising PIN photodiodes, avalanche photodiodes (APDs), single- photon avalanche diodes (SPADs), photomultiplier tubes (PMTs), silicon photomultipliers (SiPMs), charge-coupled device (CCD), complementary metal-oxide-semiconductor (CMOS) camera sensors, and combinations thereof (Turcott Col 8 lines 33-55).
As per MPEP 2413.I.A, combining prior art elements according to known methods to yield predictable results, is a rationale that may support a conclusion of obviousness. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Ripoll by integrating light detectors as in Turcott, so as to yield predictable results of light sensing.
Claims 2, 14, 28, 44, 32, 58 rejected under 35 U.S.C. 103 as being obvious over Sutin as applied to claims 1, 30 above and further in view of Durduran [US 20200090819 A1].
As per claims 14, 44, Sutin further teaches wherein the computer is configured to apply a
Sutin does not expressly teach a machine learning algorithm.
Durduran in a related field of technology teaches a machine learning algorithm (Durduran Fig 4, for ICP using ML).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Sutin by utilizing ML techniques as in Durduran. Here physiological data (BP) needs to be recorded only as static measurement at the beginning of the data acquisition. The ML performs correlation using static features. Hence the improvement is that determinations regarding pressure could be performed without requiring real time (simultaneous / dynamic) physiological data, and only the optical elements coupled to the patients during determination, thereby improving convenience for BP monitoring (Durduran ¶0019).
As per claims 2, 28, 32, 58, Sutin does not expressly teach wherein the at least one indicator of blood pressure comprises SCOS data.
Durduran, in a related field of technology teaches wherein the at least one indicator of blood pressure comprises SCOS data (Durduran ¶0057).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Sutin by integrating alternative optical approaches as discussed in Durduran ¶0057. The motivation would be to provide predictable result of measuring sub-surface blood flow based on the laser speckle statistics, for ICP monitoring.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/Primary Examiner, Art Unit 3797