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 Status
Claims 2-15 are newly added by Applicant.
Claim 1 is cancelled by Applicant.
Claims 2-15 are currently pending and are herein under examination.
Claims 2-15 are rejected.
Claim 9 is objected.
Priority
The instant application claims domestic benefit as continuation of US Application No. 13/548,637, filed 07/13/2012, which claims domestic benefit to U.S. Provisional Application No. 61/507,469, filed 07/13/2011. The claims to domestic benefit are acknowledged for claims 2-15. As such, the effective filing date for claims 2-15 is 07/13/2011.
Information Disclosure Statement
The IDSs filed 10/27/2022 follow the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of the list of references cited from these IDSs is included with this Office Action.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 209b in [56].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 107 in Fig. 1 and 110 in Fig. 1.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 9 is objected to because of the following informality: Claim 9, line 2, recites “the input, wherein the input” which should be “the user input, wherein the user input”. Appropriate correction is required.
Claim Interpretation
The following limitations in claim 2 are being interpreted as limitations that the processor of claim 2 is configured to perform: “wherein during the first operating mode, a physiological parameter value is estimated based on a single measurement; wherein during the second operating mode, a physiological parameter value is estimated based on a plurality of measurements, the plurality of measurements comprising a first measurement obtained by the physiological sensor during a first application of the physiological sensor to the measurement site and a second measurement obtained by the physiological sensor during a second application of the physiological sensor to the measurement site.”
Claim Rejections - 35 USC § 112
35 USC 112(b)
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 4, 8, 10 and 13-15 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.
Claim 4 recites the following limitation that renders the claim indefinite because it recites a method step in a system claim: “wherein the processor further determines.” MPEP 2173.05(p) recites “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). To overcome this rejection, this limitation can be amended to recite “wherein the processor is further configured to determine
Claim 8 recites the phrase “the indication” which lacks antecedent basis. To overcome this rejection, provide antecedent basis for the phrase.
Claim 8 recites “pressing the button”, which renders the claim indefinite. This phrase is indefinite because it recites a process step in a system claim. See MPEP 2173.05(p). For purpose of examination, this limitation will be interpreted as an intended use of the system.
Claim 10 recites “a third measurement obtained during a third application of the physiological sensor to the measurement site”, which renders the claim indefinite. This phrase is indefinite because it recites a process step in a system claim. Similar to the rejection above regarding claim 2. See MPEP 2173.05(p). For purpose of examination, this limitation will be interpreted as an intended use of the physiological sensor.
Claim 13, line 2, recites “the predicted parameter value” which renders the claim indefinite. It is unclear which predicted parameter value is being referenced because claim 2, last line, recites “at least one predicted parameter value”. To overcome this rejection, clarify which value is being referenced.
Claim 14, line 2, recites “the predicted parameter value” which renders the claim indefinite. It is unclear which predicted parameter value is being referenced because claim 2, last line, recites “at least one predicted parameter value”. To overcome this rejection, clarify which value is being referenced.
Claim 14, line 3, recites “the number of distinct measurements” which lacks antecedent basis. To overcome this rejection, provide antecedent basis or clarify which measurements are being referenced.
Claim 14 recites “the values associated with the plurality of measurements” which lacks antecedent basis. To overcome this rejection, provide antecedent basis.
Furthermore, claim 15 is also rejected because it depends on claim 14, which is rejected, and because it does not resolve the issue of indefiniteness.
Claim 15 recites “the predicted parameter value” which renders the claim indefinite. It is unclear which predicted parameter value is being referenced because claim 2, last line, recites “at least one predicted parameter value”. To overcome this rejection, clarify which value is being referenced.
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 2-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Step 1 asks whether the claims recite statutory subject matter. In the instant application, claims 2-15 recite a system. As such, these claims recite statutory subject matter (Step 1: YES).
Step 2A, Prong 1:
Claims that recite statutory subject matter are analyzed under Step 2A, Prong 1 to determine if they recite any concepts that equate to an abstract idea, law of nature or natural phenomena. The instant claims recite the following limitations that equate to one or more categories of judicial exception:
Claim 2 recites “wherein during the first operating mode, a physiological parameter value is estimated based on a single measurement; wherein during the second operating mode, a physiological parameter value is estimated based on a plurality of measurements, the plurality of measurements comprising a first measurement obtained by the physiological sensor during a first application of the physiological sensor to the measurement site and a second measurement obtained by the physiological sensor during a second application of the physiological sensor to the measurement site.”
Claim 3 recites “calculate a final value for the physiological parameter based on the first and second measurements.”
Claim 4 recites “determines a confidence value from a number of measurements taken.”
Claim 10 recites “wherein the plurality of measurements further comprise a third measurement obtained during a third application of the physiological sensor to the measurement site.”
Claim 11 recites “discard a measurement of the plurality of measurements; and calculate, from the remaining number of the plurality of measurements, the at least one predicted parameter value.”
Claim 12 recites “identify which measurement to discard based on at least one of a mean or a median of values associated with at least some of the plurality of measurements.”
Claim 13 recites “calculate the predicted parameter value based at least partly on averaging values associated with at least some of the plurality of measurements.”
Claim 14 recites “determine the predicted parameter value by selecting, from among values associated with the number of distinct measurements, a single value that characterizes a distribution of the values associated with the plurality of measurements.”
Claim 15 recites “select the predicted parameter value by an outlier detection algorithm.”
Limitations reciting a mental process.
Claims 2-4 and 10-15 contain limitations recited at such a high level of generality that they equate to a mental process because they are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), which the courts have identified as concepts that can be practically performed in the human mind. The paragraph below discusses the broadest reasonable interpretation (BRI) of the limitations in these claims that recite a mental process.
Regarding claim 2, the BRI of estimating a value based on a measurement or a plurality of measurements includes performing calculations such as using Beer-Lambert law, as recited in specification paras. [2] [14]. Regarding claim 3, the BRI of calculating a value includes performing calculations on pen and paper. Regarding claim 4, the BRI of determining a confidence value includes calculating a confidence interval. Regarding claim 11, the BRI of discarding a measurement includes making a mental determination, and the BRI of calculating a predicted parameter value includes averaging values. Regarding claim 12, the BRI of identifying which measurement to discard includes a mental determination. Regarding claim 13, the BRI of calculating the predicted value by averaging includes performing math on paper. Regarding claim 14, the BRI of selecting a value includes a mental determination. Regarding claim 15, the BRI of selecting by using an outlier detection algorithm includes making a mental determination and performing steps of a Z-score method.
Regarding the above cited limitations in claims 2 and 10 of “the plurality of measurements comprising a first measurement obtained by the physiological sensor during a first application of the physiological sensor to the measurement site and a second measurement obtained by the physiological sensor during a second application of the physiological sensor to the measurement site” and “wherein the plurality of measurements further comprise a third measurement obtained during a third application of the physiological sensor to the measurement site.” These limitations are being interpreted as product by process limitations. These limitations define a process previously performed to acquire the plurality of measurements, wherein the plurality of measurements are part of the recited mental process, as discussed above. See MPEP 2113.I regarding product by process limitations.
Limitations reciting a mathematical concept.
Claims 2-4, 11, 13 and 15 recite limitations that equate to a mathematical concept because they are similar to the concepts of organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)), which the courts have identified as mathematical concepts. The paragraph below discusses the broadest reasonable interpretation (BRI) of the limitations in these claims that recite a mathematical concept.
Regarding claim 2, the BRI of estimating a value based on a measurement or a plurality of measurements includes performing the Beer-Lambert law, as recited in specification paras. [2] [14]. Regarding claim 3, the BRI of calculating a final value includes averaging values. Regarding claim 4, the BRI of determining a confidence value includes calculating a confidence interval. Regarding claims 11 and 3, the BRI of calculating the value includes averaging values. Regarding claim 15, the BRI of using an outlier detection algorithm includes calculating Z-scores.
As such, claims 2-15 recite an abstract idea (Step 2A, Prong 1: YES).
Additional Elements:
Once limitations reciting a judicial exception have been identified, the claims are evaluated for additional elements. The additional elements are then analyzed under Step 2A, Prong 2 then Step 2B. The instant claims recite the following additional elements:
Claim 2 recites “A system for decreasing a probability of an erroneous value in a measured physiological parameter comprising: a physiological sensor configured to be applied to a measurement site by a user and to provide measurements indicative of the physiological parameter, wherein the physiological sensor has at least a first operating mode and a second operating mode; a user interface; a computer-readable memory storing executable instructions; and a processor, in communication with the computer-readable memory, wherein the processor is configured by the executable instructions to at least: receive a user selection of the first operating mode or the second operating mode based on a user input; operate the physiological sensor based on the user selection; and output to the user interface at least one predicted parameter value.”
Claim 3 recites “wherein to operate the physiological sensor, the processor is configured to: obtain the first measurement using the physiological sensor; output, to the user interface, instructions for the user to reapply the physiological sensor; receive an indication that the physiological sensor has been removed and reapplied; obtain the second measurement using the physiological sensor;”
Claim 4 recites “wherein the processor further”
Claim 5 recites “wherein the indication comprises a sound.”
Claim 6 recites “wherein the indication comprises a light.”
Claim 7 recites “further comprising a touch screen user interface, wherein the user input comprises a user touch interaction with the touch screen user interface.”
Claim 8 recites “further comprising a button, wherein the processor is configured to receive the indication of the user selection based on a user interaction with the button, and wherein the user input comprises pressing the button.”Claim 9 recites “further comprising a touch screen user interface, configured to receive the input, wherein the input comprises an indication from the user that the physiological sensor has been reapplied.”
Claim 11 recites “wherein the processor is configured by the executable instructions to at least”
Claim 12 recites “wherein the processor is configured by the executable instructions to at least”
Claim 13 recites “wherein the processor is configured by the executable instructions to at least”
Claim 14 recites “wherein the processor is configured by the executable instructions to at least”
Claim 15 recites “wherein the processor is configured by the executable instructions to at least”
These additional elements are analyzed below under both Step 2A, Prong 2 and Step 2B:
Step 2A, Prong 2:
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exception is not integrated into a practical application because the claims do not recite additional elements that reflect an improvement to a computer, technology, or technical field (MPEP § 2106.04(d)(1) and 2106.5(a)), require a particular treatment or prophylaxis for a disease or medical condition (MPEP § 2106.04(d)(2)), implement the recited judicial exception with a particular machine that is integral to the claim (MPEP § 2106.05(b)), effect a transformation or reduction of a particular article to a different state or thing (MPEP § 2106.05(c)), nor provide some other meaningful limitation (MPEP § 2106.05(e)). Rather, the claims include limitations that equate to an equivalent of the words “apply it” and/or to instructions to implement an abstract idea on a computer (MPEP § 2106.05(f)) and to insignificant extra-solution activity (MPEP § 2106.05(g)). The paragraphs below discuss the additional elements recited above in the instant claims.
Regarding additional elements in claims 2-15 of the system comprising a user interface, computer-readable memory, processor, and a touch screen user interface. There are no limitations that these components require anything other than a generic computer and/or generic computing system. Therefore, these limitations equate to mere instructions to implement an abstract idea on a generic computer, which the courts have established does not render an abstract idea eligible in Alice Corp. 573 U.S. at 223, 110 USPQ2d at 1983.
Regarding additional elements in claims 2-3 and 5-9 of the physiological sensor, receiving a user selection, operating the physiological sensor, outputting the predicted parameter value, obtaining the first measurement, receiving an indication, obtaining a second measurement, pressing a button, and receiving user input through a touch screen. These limitations equate to insignificant extra-solution activity of necessary data gathering or outputting. These limitations gather data necessary to perform the abstract ideas recited in claims 2-4 and 11-15 and output the result of the abstract ideas.
As such, claims 2-15 are directed to an abstract idea (Step 2A, Prong 2: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). These claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these claims recite additional elements that equate to instructions to apply the recited exception in a generic way and/or in a generic computing environment (MPEP § 2106.05(f)) and to well-understood, routine and conventional (WURC) limitations (MPEP § 2106.05(d)). The paragraphs below discuss the additional elements recited in the instant claims.
Regarding additional elements in claims 2-15 of the system comprising a user interface, computer-readable memory, and a processor. There are no limitations that these components require anything other than a generic computer and/or generic computing system. Therefore, these limitations equate to instructions to implement an abstract idea on a generic computing environment, which the courts have established does not provide an inventive concept in Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).
Regarding additional elements in claims 2-3 and 8 of a processor receiving, obtaining, and outputting, these limitations equate to receiving/transmitting data over a network, which the courts have established as WURC limitation of a generic computer in buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014). Claims 5-6 also equate to transmitting/receiving data over a network because they limit the type of data but does not change the fact that data is being transmitted/received.
Regarding the additional element in claim 2 of a computer-readable medium with stored executable instructions, this limitation equates to storing information in memory, which the courts have established as a WURC function of a generic computer in Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015).
Regarding the additional elements in claims 2-3 and 7-9 of a system comprising a physiological sensor, a user interface, a CRM, a processor that operates the physiological sensor, a touch screen user interface, a button, and generic computer functions such as obtaining and receiving data. These limitations are WURC as taught by Lane et al. (“Lane”; US 2009/0275805 A1), St. Pierre et al. (“St. Pierre”; US 9,265,429 B2; effective filing date 09/18/2009), and Kaputa et al. (“Kaputa”; Biomedical Instrumentation & Technology 44, no. 4 (2010): 350-353). The following three paragraphs discuss these WURC additional elements.
Lane discloses a system 100 containing physiological measurement sensors 103, a microcomputer 105 with associated memory 107 with stored software [96], a user display 106 which may be a touch screen with buttons [91], and pressable buttons 112 (Figure 1A). The microcomputer 105 operates the sensors 103 [94].
St. Pierre discloses a device for monitoring physiological parameters (abstract). The device 200 contains a display screen 218 which may be a touch screen which contains buttons 314, a temperature probe 212b, a processor 1108, and system memory 1112 (Figures 2B, 3A and 11).
Kaputa discloses a portable wireless vital signs monitoring system which contains biosensors for Sp02 and blood pressure, a vital signs monitor, and remote receiving/storage device (pg. 350, sec. System Overview). The vital signs monitor receives measurements from the biosensors via Bluetooth by a computer with a touch screen user interface (pg. 351, col. 1, sec. Vital Signs Monitor) (Figure 2). The vital signs monitor allows a user to input instructions such as “Take Measurement”, allowing user to decide which physiological measurement to be taken (pg. 352, col. 1, para. 2-3).
These additional elements, considered individually and in combination, do not provide an inventive concept. These additional elements equate to WURC functions/components of a generic computer and to WURC components of a system equipped with a physiological sensor, user interface, memory, processor, buttons, and a touch screen as taught above by Lane, St. Pierre, and Kaputa. Therefore, these additional elements do not transform the claimed judicial exception into a patent-eligible application of the judicial exception and do not amount to significantly more than the judicial exception itself (Step 2B: No).
As such, claims 2-15 are not patent eligible.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-15 are rejected under 35 USC 103 for being unpatentable over Lane et al.
(“Lane”; US 2009/0275805 A1) in view of Fu et al. (“Fu”; US 2011/0301426 A1).
The bold and italicized text below are the limitations of the instant claims, and the italicized text serves to map the prior art onto the instant claims.
Claim 2:
a physiological sensor configured to be applied to a measurement site by a user and to provide measurements indicative of the physiological parameter,
Lane discloses a device for monitoring physiological parameters using a sensor (abstract). Figure 1A shows a system 100 with one or more sensors 103 for measuring physiological parameters of a person 102 [94]. The sensor may be for temperature or SP02 and placed on the person’s finger [86].
wherein the physiological sensor has at least a first operating mode and a second operating mode,
Lane shows in Figure 1A the device contains a microcomputer 105 with buttons 112 used by an operator to select an instrument mode [83] [94] [83] (Figure 1A). Figure 5 shows 5 temperature sensing modes.
wherein during the first operating mode, a physiological parameter value is estimated based on a single measurement;
Lane shows in Figure 3C a temperature sensing mode that displays a measured body temperature when probe placement is correct. Figure 8 shows a similar mode of displaying a first measurement when temperature is usable.
wherein during the second operating mode, a physiological parameter value is estimated based on a plurality of measurements, the plurality of measurements comprising a first measurement obtained by the physiological sensor during a first application of the physiological sensor to the measurement site and a second measurement obtained by the physiological sensor during a second application of the physiological sensor to the measurement site;
Lane shows in Figure 5 a chart of normal body temperature ranges for different measurement sites. Each measurement site has a corresponding mode [106]. When a measurement from a measurement site is not within a normal range, the abnormal measurement indicates an operator error such as misplacement of a temperature probe [106]. The misplacement causes the system 110 to generate an intervention which is displayed to an operator [106]. The intervention displays proper probe placement, wherein the operator takes corrective action by adjusting probe placement [106]. This causes a second measurement to be taken. Figure 4 shows an example of indicating proper probe placement in a sublingual pocket [105]. A sensor can be repositioned based on intervention [121].
Although teaching continuous measuring of physiological parameters [96], Lane does not teach generating the physiological value based on combining at least two measurements.
Fu discloses a device for continual physiological monitoring and a method for reducing unreliable physiological parameter outputs [1] [4]. Fu calculates estimates for physiological measurements [9], wherein an estimate can be an average of a current estimate and the second most recent prior estimate [28].
It would have been prima facie obvious to one of ordinary skill in the art to have modified the method for calculating values of measured physiological data of Lane by taking at least two measurements to calculate a final value for a physiological parameter as taught by Fu. Motivation is taught by Fu who teaches that doing so prevents outputting unreliable physiological parameter values due to sensor malfunction, noise and motion effects, which can lead to improperly interpreting a physiological state of a person [3]. One of ordinary skill in the art would have had reasonable expectation of success because both Lane and Fu program processors to perform data analysis, wherein the processor of Lane could be programed according to Fu.
a user interface; a computer-readable memory storing executable instructions; and a processor, in communication with the computer-readable memory, wherein the processor is configured by the executable instructions to at least:
Lane shows in Figure 1 the system 100 contains a user display 106, a microcomputer 105, and memory connected 107 to the microcomputer 105 which is programmed with software [97].
receive a user selection of the first operating mode or the second operating mode based on a user input;
Lane shows in Figure 1A the microcomputer 105 contains buttons 112 used by an operator to select an instrument mode [94].
operate the physiological sensor based on the user selection; and output to the user interface at least one predicted parameter value.
Lane recites “The physiological value can then be displayed on a user readable display 106, usually following operation of a measure button 109” (Figure 1A) [94]. The microcomputer 105 detects a measurement after a user presses the measure button 109 [95] (Figure 1B).
Claim 3:
wherein to operate the physiological sensor, the processor is configured to: obtain the first measurement using the physiological sensor;
Lane recites the microcomputer 105 receives an electrical value from a sensor 103 and converts it to a corresponding physiological value [94].
output, to the user interface, instructions for the user to reapply the physiological sensor;
Lane shows in Figures 1C and 8 that when an initial measurement is incorrect, an intervention is suggested to an operator. The intervention includes displaying a correct placement of a sensor. The operator performs a corrective action according to the intervention. The sensor then measures again after the corrective action [96].
receive an indication that the physiological sensor has been removed and reapplied;
Lane recites “If the operator's corrective action is successful, the medical instrument can detect a successful intervention and corrective action by the operator by noting correct incoming data and return to a monitoring state” [96].
obtain the second measurement using the physiological sensor; and calculate a final value for the physiological parameter based on the first and second measurements.
Lane shows in Figure 1C that after a corrective measure is taken, the sensor takes further measurements. The physiological parameter is then continuously monitored once a measurement is consistent with a desired mode selected by an operator [96].
However, Lane does not teach that multiple measurements are used to calculate a final value for a physiological parameter.
Fu calculates an estimate for a physiological measurement as an average of a current estimate and the second most recent prior estimate [9] [28]. See above in claim 2 for prima facie case for obviousness.
Claims 5-6:
Lane teaches interventions produced by the system 100 can be sounds [150], wherein the intervention indicates required repositioning of a sensor [96-97].
Lane teaches a Sp02 probe contains a light sensor which is read by the medical equipment to determine if there is too much light for the probe to function properly [121]. Figure 20C shows a process similar to Figures 1C and 8, wherein a probe is repositioned and further measurements are taken.
Claim 7:
Lane teaches that the system 100 contains a user display 106 which can be a touch screen containing input buttons [91] (Figure 1A).
Claim 8:
Lane teaches that the microcomputer 105 contains buttons 112 pressed by an operator to select a measurement mode (Figure 1A) [94].
Claim 9:
Lane teaches that medical equipment offered assistance, such as interventions, automatically generated by the medical equipment can also be accessed manually by an operator via a “help” or “assistance needed” touch screen display button [91]. A displayed intervention can be removed from the display screen [115]. When these limitations are taken together, they suggest an operate touching a touch screen button to remove an intervention display.
Claim 10:
Lane shows in Figures 1C and 8 an iterative process of taking a measurement, determining if the measurement is correct, sending interventions to the operator such as repositioning of a sensor, operator taking corrective actions based on intervention, and taking further measurements to see if repositioning generates a correct measurement. This entails repeating measurement and sensor reapplication various times.
Claim 11: Lane shows in Figures 1C and 8 at least two measurements, wherein the second measurement is outputted after the system 100 determines that the physiological data is correct. Thus, the first measurement is discarded and not used to calculate the outputted parameter value.
Claims 4 and 12-14:
Lane discloses a system 100 with a microcomputer 105 and a sensor 103 to measure physiological parameters (Figure 1A). The system 100 takes multiple physiological measurements with sensors 103 (a number of measurements taken) (plurality of measurements) [96] [98] (Figure 1C). These measurements are used to calculate a value for a physiological parameter (at least one predicted parameter value) (abstract).
However, Lane does not determine a confidence value from the measurements, discard a measurement based on a mean or median of values associated with measurements, calculate a physiological value as an average of measurement values, or select a single value that characterizes values associated with the measurements.
Fu discloses a device for continual physiological monitoring and a method for reducing unreliable physiological parameter outputs [1] [4]. For consecutive windows of measurements (Wn-1, Wn) a most recent prior estimate En-1 and current estimate En, respectively, are generated for each physiological measurement. The most recent prior estimate En-1 and earlier prior estimates (e.g. En-2 and En-3) are used to determine expectations for the current estimate En. The current estimate En is compared to the expectations to determine if it is acceptable [28].
The expectation is defined by a confidence interval for a current estimate assuming a normal distribution, which has a midpoint at an expected mean for the current estimate and a confidence interval with plus/minus two standard deviations from the expected mean (determines a confidence value from a number of measurements taken) [29].
Fu recites “If the current estimate EN falls within the confidence interval, the current estimate EN conforms to expectations and is accepted” and “For purposes of calculating the confidence interval for the current estimate EN, the expected mean is set to the value of the most recent prior estimate EN-1, and the standard deviation σ is set to a value calculated using the variance of a predetermined number of prior estimates (e.g. EN-1, EN-2, EN-3, etc.) from their respective expected means (e.g. EN-2, EN-3, EN-4, etc.)” [29]. Figure 4 step 450 shows discarding the current estimate if it does not meet the expectations (identify which measurement to discard based on at least one of a mean or a median of values associated with at least some of the plurality of measurements) [29].
Fu recites “If the current estimate EN falls within the confidence interval, the current estimate EN conforms to expectations and is accepted; otherwise, the decision of whether to accept the current estimate EN is deferred pending additional analysis” (determine the predicted parameter value by selecting, from among values associated with the number of distinct measurements, a single value that characterizes a distribution of the values associated with the plurality of measurements) [29].
Fu recites calculating an estimate as an average of a current estimate and the second most recent prior estimate (calculate the predicted parameter value based at least partly on averaging values associated with at least some of the plurality of measurements) [9].
It would have been prima facie obvious to one of ordinary skill in the art to have modified the method for calculating values for measured physiological data of Lane by discarding/selecting measurements based on calculated distributions and confidence intervals as taught by Fu. Motivation is taught by Fu who teaches that doing so prevents outputting unreliable physiological parameter values due to sensor malfunction, noise and motion effects, which can lead to improperly interpreting a physiological state of a person [3]. One of ordinary skill in the art would have had reasonable expectation of success because both Lane and Fu program processors to perform data analysis, wherein the processor of Lane could be programed according to Fu.
Claim 15:
Lane discloses an algorithm for determining whether a measured value is within a range of expected values [8].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 2-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-13 of U.S. Patent No. 11,439,329 B2 (hereinafter “Patent ‘329”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious variation of the claims in Patent ‘329. The following table shows claims in Patent ‘329 that read on the claims of the instant application:
Instant Application claims
Patent ‘329
2: a physiological sensor configured to be applied to a measurement site by a user and to provide measurements indicative of the physiological parameter, wherein the physiological sensor has at least a first operating mode and a second operating mode, wherein during the first operating mode, a physiological parameter value is estimated based on a single measurement; wherein during the second operating mode, a physiological parameter value is estimated based on a plurality of measurements, the plurality of measurements comprising a first measurement obtained by the physiological sensor during a first application of the physiological sensor to the measurement site and a second measurement obtained by the physiological sensor during a second application of the physiological sensor to the measurement site; a user interface; a computer-readable memory storing executable instructions; and a processor, in communication with the computer-readable memory, wherein the processor is configured by the executable instructions to at least: receive a user selection of the first operating mode or the second operating mode based on a user input; operate the physiological sensor based on the user selection; and output to the user interface at least one predicted parameter value.
1: a physiological sensor configured to be applied to a measurement site by a user and to provide measurements indicative of the physiological parameter; a user interface; a computer-readable memory storing executable instructions; and a processor in communication with the computer readable memory, wherein the processor is configured by the executable instructions to at least: receive an indication of a user selection of a multiple measurement operating mode, wherein the user selection is made from among a plurality of operating modes of the system comprising a normal operating mode and the multiple measurement operating mode, wherein during the normal mode, the physiological parameter is estimated based only on a single measurement, and wherein during the multiple measurement operating mode, the physiological parameter is estimated based on a number of distinct measurements with a reapplication of the physiological sensor to a same measurement site between measurements; in response to receiving the indication of the user selection of the multiple measurement operating mode, output, to the user interface, instructions for the user to obtain the number of distinct measurements using the physiological sensor and to reapply the physiological sensor between each of the distinct measurements; obtain at least some of the distinct measurements of the number of distinct measurements, wherein, to obtain the at least some of the distinct measurements, the processor is configured to: output, to the user interface, instructions for the user to remove the physiological sensor from the measurement site and reapply the physiological sensor to the measurement site, receive an indication from the user that the physiological sensor has been removed and reapplied, and receive from the physiological sensor a measurement indicative of the physiological parameter after receiving the indication from the user that the physiological sensor has been removed and reapplied; determine a confidence value from the number of distinct measurements corresponding to the same measurement site; and calculate a final value for the physiological parameter based on the acquired number of distinct measurements.
3: wherein to operate the physiological sensor, the processor is configured to: obtain the first measurement using the physiological sensor; output, to the user interface, instructions for the user to reapply the physiological sensor; receive an indication that the physiological sensor has been removed and reapplied; obtain the second measurement using the physiological sensor; and calculate a final value for the physiological parameter based on the first and second measurements.
4: wherein the processor further determines a confidence value from a number of measurements taken.
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Patent ‘329 differs from the instant claims because it does not output through the user interface the value for the physiological parameter. However, this limitation was obvious in view of the claims of Patent ‘329. It would have been prima facie obvious to output the physiological parameter value through the user interface in order for the user to see the value. One of ordinary skill in the art would have had a reasonable expectation of success to output the value using the user interface because claim 4 shows that the user interface has a touch screen which can display visual prompts.
Conclusion
No claims are allowed.
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/N.A.A./Examiner, Art Unit 1687
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685