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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16756840, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The current application which is a CIP of the ‘840 application added new paragraphs including [0374]-[0377] (using the current Apps Pg Pub for paragraph numbers), discussing first derivatives of different temperature sensors and their comparison to thresholds. Claims 1 and 20, and by virtue of dependency their dependent claims, claim elements in which the prior application did not provided adequate support.
Claim Objections
Claim 5 is objected to because of the following informalities: claim 5 has two periods in it per MPEP 608.01(m) “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations.”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“control unit” in all claims which is disclosed Applicants specification (using Pg Pub for paragraph numbers) [0325] reciting “a first controller 19 a . . . In particular, the first controller 19 a is of the digital or analog type” .
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Regarding Claim 6, the claim language “to estimate a value representative of an ambient temperature that the user is in, the ambient temperature being estimated as a function of both the signals emitted by said first and second temperature sensors” does not appear to be described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when the specification does not disclose the computer and the algorithm (i.e., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. See MPEP 2161.01(I). Here, the claim recites defining a function of both the signals emitted by said first and second temperature sensors, but the specification never discloses the necessary steps and/or flowcharts of how this occurs. Phrased differently neither the specification nor the originally filed claims disclose how (ie discussion of the function; or the steps) of the “function” which take the “signals emitted by said first and second temperature sensors” and give you the “estimate a value representative of an ambient temperature”. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Regarding Claim 7, the claim language “to estimate a value representative of an ambient temperature that the user is in, the ambient temperature being estimated as a function of both the signals emitted by said first and second temperature sensors” does not appear to be described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when the specification does not disclose the computer and the algorithm (i.e., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. See MPEP 2161.01(I). Here, the claim recites defining a function of both the signals emitted by said first and second temperature sensors, but the specification never discloses the necessary steps and/or flowcharts of how this occurs. Phrased differently neither the specification nor the originally filed claims disclose how (ie discussion of the function; or the steps) of the “function” which take the “signals emitted by said first and second temperature sensors” and give you the “estimate a value representative of an ambient temperature”. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Regarding Claim 7, the claim language “multiplying the temperature value at the first surface by a coefficient dependent on the temperature value at the second surface of the support” does not appear to be described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when the specification does not disclose the computer and the algorithm (i.e., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. See MPEP 2161.01(I). Here, the claim recites the use of multiplication and a coefficient while multiplication is understandable it is the coefficient that creates an issue as the specification never discloses the necessary steps and/or flowcharts of how this occurs. For example, it merely recites it may be implemented as function which “may be” determined experimentally see [0363]. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 19 is 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 19 recites “said second controller being configured for determining at least one in the group between:
- a value representative of a body temperature of the user as a function of both the signals emitted by said first and second temperature sensors, and estimating a value representative of an ambient temperature as a function of both the signals emitted by said first and second temperature sensors;
the temperature values at the first and second surfaces.
”
Its unclear if the group is supposed to consist of all three elements or only two elements and the third is a separate element. As this is unclear the claim does not clearly define the metes and bounds of the claim and is indefinite. Based on the final statement being from the group and there being nothing explaining “the temperature values . . .” and in view of the specification [0258]-[0260] it is believed that the group is meant to consist of all three and is being interpreted as such for purposes of examination.
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 an abstract, specially a mental process and/or mathematical concept, without significantly more.
Step 1
The claimed inventions are directed to statutory subject matter as the claims recite an apparatus.
Step 2A, Prong 1
Regarding Claim 1, the recited steps of “ estimate a value representative of an internal body temperature of the user as a function of both the signals emitted by said first and second temperature sensors”, “determining a first value being the first derivative of the signal emitted by the first temperature sensor, o comparing said first value with a first threshold” and “determining a second value being the first derivative of the signal emitted by the second temperature sensor, o comparing said second value with a second threshold” directed to a mental process of performing concepts in the human mind or by a human using the aid of pen and paper. For example, this limitation simply amounts to a clinician receiving a data printout of the respective data, using that data to make a mental determinations; ie estimating the body temperature using the two respective two data inputs and mentally performing the respective derivative which are the person then mentally compares to thresholds. Further, “derivatives” and functions of the data from the temperature sensors is nothing more than performing a mathematical calculation.
Step 2A, Prong 2
Regarding Claims 1, the judicial exception is not integrated into a practical application. The claim includes the additional elements of receiving the data from temperatures sensors and outputting a result. The steps of “receiving…” amount to insignificant, extra-solution activity in that it is merely data gathering. The step of “outputting” amounts to insignificant, extra-solution activity in that it is merely outputting a result. The processor (i.e., “processor”, “microcontroller”, “computer processor”, “cloud-computing device”, “mobile device”, “user device”, “operation unit”, “analysis unit”) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining outputs from inputs) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B
Regarding Claims 1 and 8, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As with step 2A, Prong 2 above, the claim includes the additional elements of receiving the data from temperatures sensors and outputting a result. The steps of “receiving…” amount to insignificant, extra-solution activity in that it is merely data gathering. The step of “outputting” amounts to insignificant, extra-solution activity in that it is merely outputting a result. The processor (i.e., “processor”, “microcontroller”, “computer processor”, “cloud-computing device”, “mobile device”, “user device”, “operation unit”, “analysis unit”) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining outputs from inputs) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Additionally, per the Berkheimer requirement: the two temperature sensors and processor are disclosed by 1) Bell see citations below; 2) US 20150272500 see [0026], [0070], fig. 2A-3; 3) US 20040039254 see [0005], [0027], [0029].
The claim limitations when viewed individually and in combination therefore do not amount to significantly more than the abstract idea itself. The claims are therefore ineligible.
Claims 2-20 only further define the data gathered (insignificant, extra-solution activity” and/or the decisions made with the gathered data (i.e. only further define the mental process). Therefore, the claims do not include any additional elements that show integration into a practical application and do not include any additional elements that amount to significantly more than the abstract idea. The claims are ineligible.
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.
Claim(s) 1, 5-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20210186336 to Bellifemine et al. (hereinafter Bell) in view of US 20180160909 to Damania et al. (hereinafter Damania).
Regarding Claim 1, an interpretation of Bell discloses a device to detect an alarm situation for a user ([0013]), comprising:
a support wearable by the user and exhibiting a first surface configured for contacting a body surface of the user (Abstract, [0301]-[0303], Figs. 1A-1C), said support exhibiting a second surface distanced from, and opposite to, the first surface (Abstract, [0301]-[0303], Figs. 1A-1C), the wearable support comprising biometric sensors configured for emitting one or more signals representative of one or more physiological parameters of the user (Abstract, [0297], [0307], Figs. 1A-1C), said biometric sensors comprising:
a first temperature sensor configured for emitting at least one signal of a temperature at the first surface of the support (Abstract, [0307], [0325]-[0327] including “receiving as an input the signals emitted by the first and second temperature sensors 10, 11”, Figs. 1A-1C), and
a second temperature sensor configured for emitting at least one signal of a temperature at the second surface of the support (Abstract, [0307], [0325]-[0327], Figs. 1A-1C),
a control unit ([0305]-[0306], [0308], Figs. 1A-1C see also [0389]-[0390], Fig. 3) configured to:
receive as an input at least the signals emitted by the first and second temperature sensors (Abstract, [0307], [0325]-[0327], Figs. 1A-1C),
estimate a value representative of an internal body temperature of the user as a function of both the signals emitted by said first and second temperature sensors (abstract, [0330]-[0331], [0334] see also [0395]), and
wherein the control unit is configured for:
receiving as an input the signal emitted by the first temperature sensor (Abstract, [0037], [0305], [0307], [0325]-[0327], Figs. 1A-1C),
determining a first value based on the signal emitted by the first temperature sensor ([0038], [0048], [0332], [0340]),
comparing said first value with a first threshold ([0039], [0332], [0340]), and
wherein the control unit is configured for:
receiving as an input the signal emitted by the second temperature sensor (Abstract, [0047], [0305], [0307], [0325]-[0327], Figs. 1A-1C),
determining a second value based on of the signal emitted by the second temperature sensor ([0048], [0332], [0342]-[0343]),
comparing said second value with a second threshold ([0049], [0332], [0342]-[0343]),
outputting, as a function of said comparison of the first value with the first threshold and/or of the second value with the second threshold, a respective alarm signal ([0040], [0050]).
An interpretation of Bell may not explicitly recite the first and second values are first derivatives of the first temperature sensor signal and second temperature sensor signal.
However, in the same field of endeavor (medical diagnostic systems), Damania teaches determining first and second values are first derivatives of the first temperature sensor signal and second temperature sensor signal ([0026] including “comparing the change in continuous temperature sensor readings to a standardized threshold in real-time. For example, the derivative (first or second) of the temperature readings from each of the sensors or the difference of the temperature readings can be calculated in real-time and compared against a pre-determined threshold.”). Bell also discloses comparing the respective first temperature sensor signal derivate and the second temperature sensor signal derivate to thresholds ([0026]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the value representing the temperature data from being magnitude as recited by Bell to be the rate of change (first derivative) as recited Damania because it is merely it is the simple substitution of one known element (magnitude value) for another (first derivative) to obtain predictable results.
Regarding Claim 5, an interpretation of Bell discloses wherein said physiological parameters of the user to be monitored comprise the presence of a movement, a heartbeat rate, a breathing rate, and blood oxygenation and being detectable at the first surface of the support ([0307] including “a signal representative of a heart rate, one or more sensors configured for emitting a signal representative of the breathing rate, one or more sensors configured for emitting a signal representative of the presence or absence of a breathing process, one or more sensors configured for emitting a signal representative of the blood oxygen concentration.”, [0319]-[0320] including “comprises at least one accelerometer sensor 13 configured for emitting at least one signal representing a movement, in one or more directions and/or rotations”, [0324], Figs. 1A-1C), the biometric sensors comprising a sensor configured for emitting a signal representative of the heart rate ([0307]-[0309]);
wherein the control unit is configured for receiving as an input the signal representative of the heart rate, and for calculating a value representative of a time heart rate ([0308], [0314]);
the wearable support further comprises an accelerometer sensor configured for emitting at least one signal representative of a movement ([0319]-[0320]), the accelerometer sensor being configured for emitting a signal representative of a movement in one or more directions and/or one or more rotations ([0319]-[0320]), wherein the biometric sensors further comprise at least one blood saturation/oxygenation sensor configured for emitting at least one signal representative of the saturation/oxygenation of the user ([0307]-[0308], [0312]), and wherein the control unit is configured for defining one or more confidence intervals as a function of the combination of the values representative of the acquired parameters ([0368]-[0370], claim 33), the control unit being configured for:
comparing the values representative of the parameters of interest with a respective confidence interval ([0369]-[0373], Clam 33);
as a function of said comparison ([0369]-[0373], Clam 33), defining:
a safety condition, wherein the representative value falls into the respective confidence interval ([0369]-[0373] including “a safety condition, wherein the representative value falls into the respective confidence interval;”, Clam 33);
a danger condition, wherein the representative value exceeds the confidence interval ([0369]-[0373] including “a danger condition, wherein the at least one representative value exceeds the confidence interval.”, Clam 33).
emitting, in the dangerous condition, a respective alarm signal ([0369]-[0373] including “In this danger condition, the control unit 19 or the first controller 19 a of the support 2 is configured for emitting a respective alarm signal.”, Clam 33).
Regarding Claim 6, an interpretation of Bell further discloses wherein the control unit is configured to estimate a value representative of an ambient temperature being an actual temperature inside a room that the user is in ([0023], [0029], Claim 19; To the extent the “being an actual . . .” is an intended use of the device the device is structurally capable of performing the function), the ambient temperature being estimated as a function of both the signals emitted by said first and second temperature sensors ([0023], [0029], Claim 19).
Regarding Claim 7, an interpretation of Bell further discloses discloses wherein the value representative of an internal body temperature of the user is estimated by multiplying the temperature value at the first surface by a coefficient dependent on the temperature value at the second surface of the support ([0333]-[0334], claim 19), or wherein the value representative of an internal body temperature of the user is estimated by using a two-input prestored table, the inputs being the surface body temperature determined as a function of at least the signal emitted by the first sensor temperature and the ambient temperature determined as a function of at least the signal emitted by the second temperature sensor, the output value being the internal body temperature of the user, said two-input prestored table being experimentally obtained ([0335]-[0336], claim 19).
Regarding Claim 8, an interpretation of Bell further discloses wherein the control unit is configured for:
receiving as an input the signal emitted by the second temperature sensor (Abstract, [0047], [0305], [0307], [0325]-[0327], Figs. 1A-1C; Examiner notes this is already recited in claim 1),
determining a second value based on the signal emitted by the second temperature sensor ([0048], [0332], [0342]-[0343]; Examiner notes this is already recited in claim 1),
defining the first threshold as a function of said second value ([0044], claim 22).
An interpretation of Bell may not explicitly recite the second value is a first derivative of the second temperature sensor signal.
However, in the same field of endeavor (medical diagnostic systems), Damania teaches determining the second value is a first derivative of the second temperature sensor signal ([0026] including “comparing the change in continuous temperature sensor readings to a standardized threshold in real-time. For example, the derivative (first or second) of the temperature readings from each of the sensors or the difference of the temperature readings can be calculated in real-time and compared against a pre-determined threshold.”; The “each” sensor being temperature sensors). Bell also discloses comparing the respective first temperature sensor signal derivate and the second temperature sensor signal derivate to thresholds ([0026]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the value representing the temperature data from being magnitude as recited by Bell to be the rate of change (first derivative) as recited Damania because it is merely it is the simple substitution of one known element (magnitude value) for another (first derivative) to obtain predictable results.
Regarding Claim 9, an interpretation of Bell further discloses wherein the control unit is configured for:
receiving, at a time instant T, from a thermometer, an internal body temperature value detected at the instant T' on the user ([0339]-[0340], claim 24),
determining a value of the internal body temperature of the user based on the signal from the first temperature sensor, said temperature value being corrected as a function of the internal body temperature value received by the thermometer ([0339]-[0340], claim 24);
receiving, at a time instant T, from an auxiliary thermometer, a detected ambient temperature value at the instant T' in the environment wherein the user is located ([0342], claim 24),
determining a value of the ambient temperature based on the signal coming from the second temperature sensor, said temperature value being corrected as a function of the ambient temperature value received from the auxiliary thermometer ([0342], claim 24).
Regarding Claim 10, an interpretation of Bell further discloses wherein the wearable support further comprises one or more sensor among:
a sensor configured for emitting a signal representative of the breathing rate ([0297], [0307], claim 25);
an accelerometer sensor configured for emitting at least one signal representative of a movement ([0307], [0319]-[0320], claim 25);
wherein the control unit is configured for:
receiving as an input at least the signal emitted by at least one of the sensor configured for emitting a signal representative of the breathing rate, and the accelerometer sensor ([0307]-[0308], [0319]-[0320], claim 25),
determining, as a function of the signal received as the input, a signal representative of the breathing rate and/or a signal representative of the presence or absence of a breathing process ([0065], [0307]-[0308], [0319]-[0320], claim 25).
Regarding Claim 11, an interpretation of Bell further discloses wherein the wearable support comprises a vibrodine configured for generating a predetermined vibration ([0375], Claim 26, Figs. 1A-1C), the control unit selectively actuating the vibrodine after determining the signal representative of the breathing rate or the signal representative of the presence or absence of a breathing process ([0069]-[0070], [0375], Claim 26), the control unit actuating the vibrodine in absence of a breathing process or in the presence of a breathing rate less than a preset safety value ([0069]-[0070], [0375], Claim 26).
Regarding Claim 12 an interpretation of Bell further discloses wherein the wearable support comprises one or more biometric sensors ([0297], [0307]-[0308], claim 27; Examiner notes this is already claimed in claim 1), said biometric sensors being configured for emitting one or more signals representative of one or more physiological parameters of the user detectable at the first surface of the support ([0297], [0307]-[0308], claim 27; Examiner notes this is already claimed in claim 1) wherein the control unit is configured for:
receiving as an input said one or more signals representative of physiological parameters ([0297], [0307]-[0309], claim 27);
determining one or more values representative of the respective physiological parameters ([0297], [0307]-[0309], claim 27); and
wherein the one or more biometric sensors comprise at least one in the group ([0297], [0307]-[0309], claim 27) among:
a sensor configured for emitting a signal representative of the heart rate ([0297], [0307]-[0309], claim 27);
the control unit being configured for receiving as an input at least one ([0297], [0307]-[0309], claim 27) among:
a signal representative of the heart rate ([0297], [0307]-[0309], claim 27);
said control unit being configured for calculating respectively at least one ([0297], [0307]-[0308], [0313]-[0314], claim 27) among:
a value representative of a time heart rate ([0297], [0307]-[0308], [0313]-[0314], claim 27).
Regarding Claim 13, an interpretation of Bell further discloses wherein the wearable support comprises an accelerometer sensor configured for emitting a signal representative of at least one between the rate and the presence or absence of a breathing process of the user ([0307]-[0308], [0319]-[0320], claim 28).
Regarding Claim 14, an interpretation of Bell further discloses wherein the wearable support further comprises an auxiliary accelerometer sensor ([0119], [0122], [0319]-[0321], claim 29 see also [0307]-[0308]), the control unit being configured for receiving the signals from the accelerometer sensors and for processing signals together for obtaining a signal representative of at least one between the rate and the presence or absence of a heartbeat of the user ([0119], [0122], [0319]-[0321] including “determining the presence of heartbeat”, claim 29 see also [0307]-[0308]), the accelerometer sensor being positioned at the first surface of the wearable support for contacting the user when the device is in use ([0319]-[0321] including “the presence of a first accelerometer 13 on the surface 2 a of the wearable support 2 in contact with the user's body would receive first signals; the presence of a second accelerometer 13 positioned for example at the surface 2 b facing outwards”, claim 29 see also [0119], [0122], [0307]-[0308]), the auxiliary accelerometer sensor being positioned on a support distanced from the first surface and not rigidly coupled to the accelerometer sensor ([0319]-[0321] including “the presence of a second accelerometer 13 positioned for example at the surface 2 b facing outwards, and mounted on disconnected circuits or in any case not rigidly connected (connected for example by flat cable) to the first accelerometer sensor”, claim 29 see also [0119], [0122], [0307]-[0308]), the signal processing being responsible for eliminating or reducing the interferences due to undesired external vibrations ([0321], claim 29 see also [0307]-[0308], [0319]-[0320]).
Regarding Claim 15 an interpretation of Bell further discloses at least one blood saturation/oxygenation sensor configured for emitting at least one signal representative of the blood saturation/oxygenation in the user ([0097], [0307]-[0308], [0318]) or a blood C02 concentration sensor configured for emitting at least one signal representative of a blood C02 concentration in the user ([0098], [0126]-[0128], [0318]), said sensor being distinct from the support and connectable by a cable or wirelessly to the control unit ([0126]-[0128], [0318], Claim 30).
Regarding Claim 16, an interpretation of Bell further discloses wherein the control unit is configured for storing the signal representative of at least one between the rate and presence or absence of a breathing process in the user in a memory connected to the control unit itself ([0129], [0306], Claim 31), and for graphically representing and saving in a memory the graph of the time trend of the signal representative of at least one between the rate and presence or absence of a breathing process in the user on a display connected to the control unit itself ([0130], [0306], [0319], Claim 31 see also [0357]).
Regarding Claim 17, an interpretation of Bell further discloses wherein the wearable support comprises signal transmission device ([0145]-[0147], [0346], [0356], Claim 32), said transmission device being configured for remotely transmitting at least one in the group ([0145]-[0147], [0346] including “the transmission means 15 are configured for remotely transmitting at least one in the group between”, [0356], Claim 32) among: the temperature value at the first surface of the support ([0145]-[0148], [0346]-[0347] including “the temperature values at the first and second surfaces 2 a, 2 b of the support 2;”, [0356], Claim 32)
Regarding Claim 18, an interpretation of Bell further discloses wherein the control unit is configured for defining one or more confidence intervals as a function of the combination of the values representative of the acquired parameters ([0172], [0368]-[0370], claim 33), the control unit being configured for:
comparing the values representative of the parameters of interest with a respective confidence interval ([0174], [0369]-[0373], Clam 33);
as a function of said comparison ([0369]-[0373], Clam 33), defining:
a safety condition, wherein the representative value falls into the respective confidence interval ([0176], [0369]-[0373] including “a safety condition, wherein the representative value falls into the respective confidence interval;”, Clam 33);
a danger condition, wherein the representative value exceeds the confidence interval ([0177], [0369]-[0373] including “a danger condition, wherein the at least one representative value exceeds the confidence interval.”, Clam 33).
emitting, in the dangerous condition, a respective alarm signal ([0178], [0369]-[0373] including “In this danger condition, the control unit 19 or the first controller 19 a of the support 2 is configured for emitting a respective alarm signal.”, Clam 33).
Regarding Claim 19, an interpretation of Bell further discloses comprising an external device distanced from the support ([0222], [0378], claim 34, fig. 4), said external device comprising:
signal receiving means configured for receiving remotely from the transmission means of the wearable support at least one in the group ([0223]-[0224], [0378], claim 34, fig. 4) among:
the value representative of the body temperature of the user ([0223], [0378]-[0379], claim 34, fig. 4);
the control unit comprising at least one second controller engaged with the external device and connected at least to the signal receiving means of said external device ([0234]-[0235], [0378], [0389], claim 34, fig. 4), said second controller being configured for receiving as an input at least one in the group ([0378], [0389], [0391], claim 34, fig. 4) among:
the value representative of the body temperature of the user ([0236], [0378], [0389], [0391], claim 34, fig. 4 see also [0369]);
said second controller being configured for determining at least one in the group ([0378], [0389], [0391], claim 34, fig. 4) between:
a value representative of a body temperature of the user as a function of both the signals emitted by said first and second temperature sensors ([0390], [0395], claim 34, fig. 4).
Regarding Claim 20, an interpretation of Bell discloses a device to detect an alarm situation for a user ([0013]) comprising:
a support wearable by the user and exhibiting a first surface configured for facing and contacting a body surface of the user (Abstract, [0301]-[0303], Figs. 1A-1C), said support exhibiting at least one second surface distanced from, and opposite to, the first surface (Abstract, [0301]-[0303], Figs. 1A-1C),
biometric sensors configured for emitting one or more signals representative of one or more physiological parameters of the user (Abstract, [0297], [0307], Figs. 1A-1C), said physiological parameters of the user to be monitored comprising the presence of a movement, a heartbeat rate, a breathing rate, and blood oxygenation and being detectable at the first surface of the support ([0307] including “a signal representative of a heart rate, one or more sensors configured for emitting a signal representative of the breathing rate, one or more sensors configured for emitting a signal representative of the presence or absence of a breathing process, one or more sensors configured for emitting a signal representative of the blood oxygen concentration.”, [0319]-[0320] including “comprises at least one accelerometer sensor 13 configured for emitting at least one signal representing a movement, in one or more directions and/or rotations”, [0324], Figs. 1A-1C), the biometric sensors comprising:
a sensor configured for emitting a signal representative of the heart rate ([0307]-[0309], [0314]);
a first temperature sensor configured for emitting at least one signal of a temperature at the first surface of the support (Abstract, [0307], [0325]-[0327] including “receiving as an input the signals emitted by the first and second temperature sensors 10, 11”, Figs. 1A-1C), and
a second temperature sensor configured for emitting at least one signal of a temperature at the second surface of the support (Abstract, [0307], [0325]-[0327], Figs. 1A-1C),
an accelerometer sensor configured for emitting at least one signal representative of a movement, the accelerometer sensor being configured for emitting a signal representative of a movement in one or more directions and/or one or more rotations ([0319]-[0321]),
a blood saturation/oxygenation sensor configured for emitting at least one signal representative of the saturation/oxygenation of the user ([0307]-[0308], [0312])
wherein a control unit ([0305]-[0306], [0308], Figs. 1A-1C see also [0389]-[0390], Fig. 3) is configured to:
receiving as an input the signal representative of the heart rate, and for calculating a value representative of a time heart rate ([0308], [0314]);
receive as an input the signals emitted by the first and second temperature sensors (Abstract, [0037], [0305], [0307], [0325]-[0327], Figs. 1A-1C),
estimate a value representative of an internal body temperature of the user as a function of both the signals emitted by said first and second temperature sensors (abstract, [0330]-[0331], [0334] see also [0395]),
the control unit is configured for:
receiving as an input the signal emitted by the first temperature sensor (Abstract, [0037], [0305], [0307], [0325]-[0327], Figs. 1A-1C),
determining a first value based on the signal emitted by the first temperature sensor ([0038], [0048], [0332], [0340]),
comparing said first value with a first threshold ([0039], [0332], [0340]),
outputting, as a function of said comparison, a respective alarm signal ([0049], [0332], [0342]-[0343]),
outputting, as a function of said comparison of the first value with the first threshold and/or of the second value with the second threshold, a respective alarm signal ([0040], [0050]),
defining one or more confidence intervals as a function of the combination of the values representative of the acquired parameters ([0368]-[0370], claim 33),
comparing the values representative of the parameters of interest with a respective confidence interval ([0369]-[0373], Clam 33);
as a function of said comparison ([0369]-[0373], Clam 33), defining:
a safety condition, wherein the representative value falls into the respective confidence interval ([0369]-[0373] including “a safety condition, wherein the representative value falls into the respective confidence interval;”, Clam 33);
a danger condition, wherein the representative value exceeds the confidence interval ([0369]-[0373] including “a danger condition, wherein the at least one representative value exceeds the confidence interval.”, Clam 33).
emitting, in the dangerous condition, a respective alarm signal ([0369]-[0373] including “In this danger condition, the control unit 19 or the first controller 19 a of the support 2 is configured for emitting a respective alarm signal.”, Clam 33).
An interpretation of Bell may not explicitly recite the first value is a first derivative of the first temperature sensor signal.
However, in the same field of endeavor (medical diagnostic systems), Damania teaches determining the first value is a first derivative of the first temperature sensor signal ([0026] including “comparing the change in continuous temperature sensor readings to a standardized threshold in real-time. For example, the derivative (first or second) of the temperature readings from each of the sensors or the difference of the temperature readings can be calculated in real-time and compared against a pre-determined threshold.”). Bell also discloses comparing the various temperature sensor signals derivatives against respective thresholds ([0026]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the value representing the temperature data from being magnitude as recited by Bell to be the rate of change (first derivative) as recited Damania because it is merely it is the simple substitution of one known element (magnitude value) for another (first derivative) to obtain predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bell in view of Damania in further view of US 20110202495 to Gawlick (hereinafter Gawlick).
Regarding Claim 2, an interpretation of Bell discloses issuing an alarm based on determinations of the comparisons of both the first and second temperature values to respective thresholds ([0343]-[0344]).
An interpretation of Bell may not explicitly disclose wherein the control unit is configured to issue the respective alarm signal if the first value exceeds the first threshold and not to issue any alarm if the first value exceeds the first threshold and the second value is below a third threshold lower than the second threshold.
However, in the same field of endeavor (medical diagnostic systems), Gawlick teaches various parameters each having a plurality of relevant alarms and issuing an alarm only if certain elements are present such as parameter 1 above a tier 1 threshold and parameter 2 above tier 2 threshold etc. (Figs. 10-11). As such reading Bell in view of Damania in further view of Gawlick would render obvious setting up the recited the threshold crossing to cause an alarm.
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the alarm condition of Bell in view Damania to include alarms based on the readings passing varied tiered thresholds as recited by Gawlick because this is merely combining prior art elements according to known methods to yield predictable results.
Regarding Claim 3, an interpretation of Bell discloses issuing an alarm based on determinations of the comparisons of both the first and second temperature values to respective thresholds ([0343]-[0344]).
An interpretation of Bell may not explicitly disclose wherein the control unit is configured to issue the respective alarm signal if the first value exceeds the first threshold and the second value exceeds the second threshold.
However, in the same field of endeavor (medical diagnostic systems), Gawlick teaches various parameters each having a plurality of relevant alarms and issuing an alarm only if certain elements are present such as parameter 1 above a tier 1 threshold and parameter 2 above tier 2 threshold etc. (Figs. 10-11). As such reading Bell in view of Damania in further view of Gawlick would render obvious setting up the recited the threshold crossing to cause an alarm.
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the alarm condition of Bell in view Damania to include alarms based on the readings passing varied tiered thresholds as recited by Gawlick because this is merely combining prior art elements according to known methods to yield predictable results.
Regarding Claim 4, an interpretation of Bell discloses issuing an alarm based on determinations of the comparisons of both the first and second temperature values to respective thresholds ([0343]-[0344]).
An interpretation of Bell may not explicitly disclose wherein the control unit is configured to determine if the first value exceeds the first threshold and if the second value is below the second threshold and above the third threshold, in case the first value exceeds the first threshold and the second value is below the second threshold and above the third threshold, the control unit is configured to determine whether a temperature measured with the first temperature sensor is higher than a reference temperature and to issue the respective alarm signal only if the temperature measured with the first temperature sensor is higher than the reference temperature.
However, in the same field of endeavor (medical diagnostic systems), Gawlick teaches various parameters each having a plurality of relevant alarms and issuing an alarm only if certain elements are present such as parameter 1 above a tier 1 threshold and parameter 2 above tier 2 threshold etc. (Figs. 10-11). As such reading Bell in view of Damania in further view of Gawlick would render obvious setting up the recited the threshold crossing to cause an alarm.
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the alarm condition of Bell in view Damania to include alarms based on the readings passing varied tiered thresholds as recited by Gawlick because this is merely combining prior art elements according to known methods to yield predictable results.
Conclusion
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/James Moss/Examiner, Art Unit 3792