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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Such claim limitation(s) is/are:
Communication means (as part of the main body), first recited in claim 1 (radio, NFC, cable, or optical, p. 5 as filed; SPI bus, p. 9 as filed; Bluetooth or WLAN, p. 16 as filed)
Communication means (as part of an air quality measurement device), first recited in claim 15 (Bluetooth, p. 28 as filed)
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:
Air quality measurement device, first recited in claim 15 (humidity sensors, temperature sensors, atmospheric pressure sensors, MOS-type gas sensors (metal-oxide-semiconductor), airborne- particles sensors, pollen sensors, ozone (O3) sensors, nitrogen dioxide (NO2) sensors, sulfur dioxide (SO2) sensors and carbon monoxide (CO) sensors, or other type of gas sensors, p. 6 as filed)
Computing unit (part of air quality measurement device), first recited in claim 15 (microcomputer, p. 41)
Computing unit (separate), first recited in claim 15 (personal computer and/or smartphone, p. 33; handheld PC, p. 41)
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 Objections
Claim 9 is objected to because of the following informalities:
Claim 9 recites “one of the longitudinal axis”; “axis” is a singular term. This should refer to “axes” if more than one axis is present.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 16 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 16 calls for the system to include “one or more air quality sensors”; claim 15 already calls for the system to include one or more air quality sensors. It is unclear if the one or more sensors of claim 16 include the one or more sensors of claim 15 or if these are in addition to the one or more sensors as set forth in claim 15. Clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-9 and 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuelke (US 2017/0273597) in view of Speldrich (US 2011/0247411).
Regarding claims 1 and 4, Schuelke discloses a portable, handheld electronic spirometer for the evaluation of lung function parameters comprising:
a tubular mouthpiece with
- a proximal opening for insertion into the mouth of a user (element 135),
- a distal opening (at element 130a, see figure 15),
- a main fluid channel extending between the proximal opening and the distal opening (element 130c),
- a first opening and a second opening positioned at a longitudinal distance to the first opening (paragraph [0098] discloses the device including a plurality of sensors each within its own tube such that at least one of these individual tubes requires its own openings to distinguish it from the other tubes within the channel)
-and a flow restrictor in the form of a perforated disk positioned in a cross-sectional orientation in the main fluid channel between the first and second openings (paragraph [0098], the device may include multiple sensors, one of which may include a screen in a tube; as this is separate from other sensors in other tubes the screen must inherently be located between openings to other flow paths/tubes); and
first second fluid openings connectible with the first and second openings of the mouthpiece (paragraph [0098], each of the plurality of sensors within the device is within its own tube),
a thermal fluid flow sensor positioned at a bypass fluid channel extending between the first and the second fluid opening for generating a signal in response to the fluid flow in the bypass fluid channel (paragraph [0098], the device may include multiple sensors, one of which may be a thermal flow sensor disposed within a tube), and
- a microcontroller connected with the fluid flow sensor for calculating the fluid flow from the signal generated by the flow sensor (paragraph [0118]), and
- a communication means for the exchange of data related to the fluid flow generated by the micro-controller of the spirometer (paragraph [0110]);
wherein:
i) the cross-section of the bypass fluid channel with respect to the cross-section of the main fluid channel, and ii) the perforated disk are adapted or configured in a such way that the flow resistance of the spirometer does not exceed 0.15 kPa/(L/s) (paragraph [0076]).
Schuelke does not specify the arrangements of the tubes and sensors, particularly where the sensor, its bypass channel, and its controller and communication means are located in a “main body” separate from the “tubular mouthpiece” accessed via the first and second openings which are lateral openings in the “tubular mouthpiece”, where the main fluid channel exhibits a cross-sectional area (Am) in the range of 200 mm2 to 1400 mm2 and the bypass channel exhibits a cross-sectional area (Ab) in the range of from 1 mm2 to 16 mm2, or that the thermal sensor is a MEMS-based thermal fluid flow sensor.
Speldrich teaches a portable, handheld electronic spirometer for the evaluation of lung function parameters comprising:
(a) a tube with
- a proximal opening (at element 62, figure 9),
- a distal opening (at element 68, figure 9),
- a main fluid channel extending between the proximal opening and the distal opening (element 68),
- a first lateral opening (at element 70, figure 9),
- a second lateral opening positioned at a longitudinal distance to the first lateral opening (at element 72, figure 9), and
- a flow restrictor in the form of a perforated disk positioned in a cross-sectional orientation in the main fluid channel between the first and the second lateral opening (elements 64, 66); and
(b) a main body with
- a first fluid opening connectible with the first lateral opening of the mouthpiece (at element 70),
- a second fluid opening connectible with the second lateral opening of the mouthpiece (at element 72),
- a bypass fluid channel extending between the first and the second fluid opening (element 46),
- a MEMS-based thermal fluid flow sensor positioned at the bypass fluid channel for generating a signal in response to the fluid flow in the bypass fluid channel (element 42; paragraph [0021], [0059]),
- a microcontroller connected with the fluid flow sensor for calculating the fluid flow from the signal generated by the flow sensor (paragraph [0061] of Speldrich incorporates the features of the sensor of US 6655207 which teaches this microcontroller at column 9, lines 13-32), and
- a communication means for the exchange of data related to the fluid flow generated by the microcontroller of the spirometer (paragraph [0061] of Speldrich incorporates the features of the sensor of US 6655207 which teaches this communication means as elements 104).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Schuelke with the various tubes and sensors arranged into a first tube and a main body, where the flow restrictor of the first tube is between lateral openings in the main fluid channel of the first tube, where the thermal sensor in the bypass fluid channel is a MEMS-based thermal sensor and the sensor in the bypass fluid channel is directly connected to the microcontroller and communication means, as taught by Speldrich, because Schuelke does not provide specifics of how the tubes and sensors of the device should be arranged with respect to each other or details of the thermal sensor, and Speldrich teaches a conventional configuration used for diverting fluid to allow thermal measurement of flow by use of a flow restrictor to cause redirection of flow into a lateral opening of a bypass channel.
Schuelke, as modified, does not provide a preferred cross-sectional area of the main channel or bypass channel; however, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have made the main fluid channel with a cross-sectional area (Am) in the range of 200 mm2 to 1400 mm2 and the bypass channel with a cross-sectional area (Ab) in the range of from 1 mm2 to 16 mm2 since Applicant has not disclosed use of these particular dimensions as providing a particular advantage, solving a stated problem, or serving a different purpose than that of Schuelke as modified above. Moreover, it appears that either would perform equally well to allow performance of respiratory monitoring via spirometry. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Schuelke with the main fluid channel exhibiting a cross-sectional area (Am) in the range of 200 mm2 to 1400 mm2 and the bypass channel with a cross-sectional area (Ab) in the range of from 1 mm2 to 16 mm2, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Schuelke as modified above.
Regarding claim 2, Speldrich further teaches configuring the cross-sections of the bypass channel and main channel and the perforated disk such as to cause a desired fluid flow in the bypass channel to be significantly lower than that of the fluid flow in the main channel (paragraph [0059], “a fraction of the flow rate of the fluid in the flow channel”), but does not explicitly teach the desired fluid flow in the bypass channel being from 1:2.5 to 1:200 of the fluid flow rate in the main channel. However, this would be prima facie obvious as these ranges are “so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.” In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018) See MPEP 2144.05(I).
Regarding claim 3, Schuelke’s disclosure of flow resistance being in the range from 0.01 to 0.14 kPa/(L/s) is not limited to any fluid flow rate (paragraph [0076]).
Regarding claim 5, Schuelke, as modified, does not disclose that the ratio of the cross-sectional area (Am) of the main fluid channel to the cross-sectional area (Ab) of the bypass fluid channel ranges from 100 to 800, but, a device having these characteristics would be prima facie obvious as the instant application does not teach a criticality to this range, where it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Regarding claim 6, Schuelke, as modified, does not specifically disclose that the perforated disk exhibits from 15 to 100 perforations; however, a device having these characteristics would be prima facie obvious as the instant application does not teach a criticality to this range, where it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Regarding claim 7, Schuelke, as modified above, does not further disclose that the cross-sectional area (Am) of the main fluid channel ranges from 530 mm2 to 760 mm2 and the cross-sectional area of the bypass fluid channel ranges from 1 mm2 to 4 mm2; and wherein further the perforated disk exhibits from 30 to 60 perforations with a circular, or regular polygonal shape, and a total combined area of all perforations from 30 % to 50 % of the cross-sectional area of the main fluid channel at the position of the perforated disk. However, making a device having these characteristics would be prima facie obvious as the instant application does not teach a criticality to these ranges, where it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Regarding claim 8, Schuelke, as modified by Speldrich, does not disclose the bypass fluid channel having a rectangular cross-section; neither Schuelke nor Speldrich discuss a preferred cross-sectional shape of the bypass fluid channel. However, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have configured the bypass channel with a rectangular cross-section, since Applicant has not disclosed use of this particular geometry as providing a particular advantage, solving a stated problem, or serving a different purpose than that of bypass channels of Schuelke as modified by Speldrich. Moreover, it appears that any cross-sectional shape would perform equally well to allow fluid flow. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Schuelke as modified by Speldrich with the bypass channel having a rectangular cross-section, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Schuelke and Speldrich.
Regarding claim 9, Speldrich’s MEMS-based thermal fluid flow sensor is arranged centrally on one of the transverse axes of the bypass fluid channel which is perpendicular to one of the longitudinal axes of the bypass fluid channel (figure 9; see also figures 1, 5 of US 6655207 as incorporated in paragraph [0061] of Speldrich).
Regarding claim 11, Schuelke further discloses an acceleration sensor which is different from the MEMS-based thermal fluid flow sensor (paragraph [0149]).
Regarding claim 12, Schuelke further discloses a gyroscope which is different from the MEMS-based thermal fluid flow sensor and the acceleration sensor (paragraph [0149]).
Regarding claim 13, Schuelke further discloses one or more of the following sensors: (a) a heart rate sensor, (b) a blood oxygen saturation sensor, (c) a temperature sensor for measuring the temperature of the environment, (d) an atmospheric pressure sensor, (e) a moisture sensor; wherein each of the one or more sensors is directly or indirectly connected with the microcontroller such that the microcontroller is capable of receiving a signal from each of the one or more sensors (paragraph [0104], [0150]).
Regarding claim 14, Schuelke further discloses method for measuring a lung function associated health parameter of a human subject, the method comprising a step of the human subject performing a breathing manoeuvre through the spirometer of claim 1 (paragraph [0006]).
Regarding claims 15 and 16, Schuelke further discloses a system, or kit, comprising:
- the portable, handheld electronic spirometer of claim 1 (see above), and
- a first air quality measurement device comprising communication means adapted for data exchange with the portable, handheld electronic spirometer and/or with a separate computing unit, and equipped with one or more air quality sensors, where the one or more air quality sensors are selected from the group consisting of humidity sensors, temperature sensors, atmospheric pressure sensors, MOS-type gas sensors (metal-oxide-semiconductor), airborne-particles sensors, pollen sensors, ozone (O3) sensors, nitrogen dioxide (NO2) sensors, sulfur dioxide (SO2) sensors carbon monoxide (CO) sensors and other type of gas sensors, for determining determine the air quality at the location of the first air quality measurement device (paragraph [0105]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuelke, as modified and applied above, and further in view of Liu (S. Liu, S. Pan, F. Xue, L. Nay, J. Miao and L. K. Norford, "Optimization of Hot-Wire Airflow Sensors on an Out-of-Plane Glass Bubble for 2-D Detection," in Journal of Microelectromechanical Systems, vol. 24, no. 4, pp. 940-948, Aug. 2015, doi: 10.1109/JMEMS.2014.2360378).
Regarding claim 10, Speldrich does not teach the MEMS-based thermal fluid flow sensor being a bidirectional, monolithic CMOS flow sensor comprising a sensor chip, the chip comprising an encapsulated gas bubble, a microheater in the form of a heating rod comprising a plurality of dynamically controlled thermal resistors for heating the gas bubble, a first plurality of thermopiles arranged in rows and located on a first side of the gas bubble, and a second plurality of thermopiles arranged in rows and located on a second side of the gas bubble which is opposite to the first side. Liu teaches a MEMS-based thermal fluid flow sensor which is a bidirectional, monolithic CMOS flow sensor comprising a sensor chip, the chip comprising an encapsulated gas bubble, a microheater in the form of a heating rod comprising a plurality of dynamically controlled thermal resistors for heating the gas bubble, a first plurality of thermopiles arranged in rows and located on a first side of the gas bubble, and a second plurality of thermopiles arranged in rows and located on a second side of the gas bubble which is opposite to the first side (see entire document, for example, section II). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Schuelke in view of Speldrich with the MEMS sensor being a bidirectional, monolithic CMOS flow sensor with gas bubble and thermopiles, as taught by Liu, as it would merely involve the simple substitution of one known element for another to obtain predictable results allowing sensing of air flow.
Conclusion
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/KAREN E TOTH/ Examiner, Art Unit 3791
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