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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on May 14, 2026 is acknowledged. Claims 1-17 and 21-24 are pending in the application.
Claim Objections
Claims 1, 10, and 21-24 are objected to because of the following informalities:
in claim 1, line 8: a comma should be inserted after “housing”;
in claim 10, line 5: “networked” should be inserted before “breathing”;
in claim 10, line 7: “networked” should be inserted before “breathing”;
in claim 10, line 8: a comma should be inserted after “housing”;
in claim 10, line 16: “a” should be inserted before “breathing”;
in claim 21, line 7: a comma should be inserted after “housing”;
in claim 21, line 7: a comma should be inserted after “housing”;
in claim 22, line 1: “a breathing” should be “the breathing”;
in claim 22, line 2: “a breathing” should be “the breathing”;
in claim 23, line 1: “a breathing” should be “the breathing”;
in claim 23, line 2: “a breathing” should be “the breathing”;
in claim 24, line 1: “a breathing” should be “the breathing”; and
in claim 24, line 2: “a breathing” should be “the breathing”.
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.
Claims 1-17 and 21-24 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 1 recites “information” in line 12, but it is not clear if this recitation is the same as, related to, or different from the recitation “information” in line 10. The similar phraseology and context of the claim suggest that they are the same, but the lack of the definite article “the” suggests that they are different. If the recitations are the same, the present recitation should be “the information”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claims 2-9 are rejected by virtue of their dependence from claim 1.
Claim 10 recites “information” in line 12, but it is not clear if this recitation is the same as, related to, or different from the recitation “information” in line 10. The similar phraseology and context of the claim suggest that they are the same, but the lack of the definite article “the” suggests that they are different. If the recitations are the same, the present recitation should be “the information”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claims 11-17 are rejected by virtue of their dependence from claim 10.
Claim 21 recites “information” in line 10, but it is not clear if this recitation is the same as, related to, or different from the recitation “information” in line 9. The similar phraseology and context of the claim suggest that they are the same, but the lack of the definite article “the” suggests that they are different. If the recitations are the same, the present recitation should be “the information”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claims 22-24 are rejected by virtue of their dependence from claim 21.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 7-11, and 15-17 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Huang et al (US Patent Application Publication 2009/0234201), hereinafter Huang.
Regarding Claims 1 and 10, Huang teaches a method of monitoring health by way of a belt with a stress sensing sensor (see abstract and Figs. 1-10). Huang teaches a networked breathing/breathing effort sensing apparatus (see abstract, ¶[0025], ¶[0041], ¶[0043], and ¶[0046] the combinations of the embodiments, including the wired or wireless output and input interface 27/47/77, as Huang teaches the elements required for the breathing effort sensing apparatus, Huang teaches the breathing effort sensing apparatus as currently required in the claims; Figs. 1-10) comprising:
a housing with an upper surface, a lower surface and four side walls defining an interior chamber (see ¶[0041] and Figs. 6-8, the sensor/locking head 4 are surrounded by four rounded sides, and an upper and lower surface; see also ¶[0044] and Fig. 10, the interior surrounded by the shell 50);
an armband securable to the housing (¶[0038] the belt for binding to the body of the user, to different body parts including the front arm, wrist, elbow, and upper arm, ¶[0025], ¶[0041], and ¶[0043] the stress sensor 23/43 to receive tension from the belt; Figs. 1-3 and 6-9);
an optical sensor partially positioned within the housing of the breathing effort sensing apparatus with a sensing surface of the optical sensor facing external to the breathing effort sensing apparatus (¶[0025] and ¶[0041] the additional sensor 26/46, such as for light; Figs. 6 and 8);
a tension sensor positioned within the housing wherein the tension sensor receives tension information from the arm band (¶[0025], ¶[0041], and ¶[0043] the stress sensor 23/43 to receive tension from the belt; Figs. 1-3 and 6-9);
a processor positioned within the housing configured to receive information from the optical sensor and the tension sensor (¶[0025] and ¶[0041] the printed circuit board component 24/44, ¶[0043] which includes the microprocessor 70, which receives sensor values from the analog digital conversion interface 72; Figs. 1-3 and 6-9);
a transmitter positioned within the housing configured to receive information from the processor and transmit the information to an external device (¶[0025], ¶[0041], and ¶[0043] the wired or wireless output and input interface 27/47/77 to perform signal transfer and remote monitoring; Figs. 1-3 and 6-9); and
a power source (¶[0025], ¶[0041], and ¶[0043] the PCB 24/44 has power supplied via the battery 45/75; Figs. 1-3 and 6-9),
wherein the networked breathing effort sensing apparatus is in communication with one or more of breathing assistance device (¶[0025], ¶[0041], and ¶[0043] the wired or wireless output and input interface 27/47/77 to perform signal transfer and remote monitoring, the device, ¶[0010] and ¶[0025]-[0030] the guide/instructions sent to the user via an output device, such as via a speaker, as the output device is guiding the user’s breathing, such a speaker would fall under the BRI of a breathing assistance device), a central location, and
an electronic device (¶[0025], ¶[0041], and ¶[0043] the wired or wireless output and input interface 27/47/77 to perform signal transfer and remote monitoring, here, as the wired or wireless output and input interface 27/47/77 is utilized to communicate with a device for remote monitoring, such a device would necessarily be an electronic device as it is capable of receiving signals from the wired or wireless output and input interface 27/47/77; Figs. 1-3 and 6-9).
Regarding Claims 2 and 11, Huang teaches the device of claims 1 and 10 as stated above. Huang further teaches the optical sensor is configurable to detect absorption of red light and infrared light (¶[0025] and ¶[0041] the additional sensor 26/46, such as for light; Figs. 6 and 8). It is noted that this recitation is not positively recited, but merely provide intended use or conditions of use of the positively recited structural recitations (i.e., the optical sensor is not configured to detect absorption of red light and infrared light, but configurable to do so). Therefore, the examiner interprets the intended use/conditions of the claims in such a manner that if prior art, under 35 U.S.C. § 102, teaches the positively recited structural recitations that could be configured to perform the intended use/conditions of the claims, as satisfying the scope of the limitation pertaining to the intended use/conditions, and the prior art thereby teaching the claims as a whole in the application. In this case, the light based sensor of Huang could be configured to detect absorption of red light and infrared light (a well known application for monitoring heart rate), so Huang teaches the limitation of claims 2 and 11 as currently recited.
Regarding Claims 7 and 15, Huang teaches the device of claims 1 and 10 as stated above. Huang further teaches the transmitter is configured to transmit data to a breathing assistance device (¶[0025], ¶[0041], and ¶[0043] the wired or wireless output and input interface 27/47/77 to perform signal transfer and remote monitoring, the device, ¶[0010] and ¶[0025]-[0030] the guide/instructions sent to the user via an output device, such as via a speaker, which would necessitate information being sent, as the output device is guiding the user’s breathing, such a speaker would fall under the BRI of a breathing assistance device).
Regarding Claims 8 and 16, Huang teaches the device of claims 1 and 10 as stated above. Huang further teaches the transmitter is configured to transmit an instruction to a breathing assistance device (¶[0025], ¶[0041], and ¶[0043] the wired or wireless output and input interface 27/47/77 to perform signal transfer and remote monitoring, the device, ¶[0010] and ¶[0025]-[0030] the guide/instructions sent to the user via an output device, such as via a speaker, as the output device is guiding the user’s breathing, such a speaker would fall under the BRI of a breathing assistance device).
Regarding Claims 9 and 17, Huang teaches the device of claims 1 and 10 as stated above. Huang further teaches the transmitter is configured to transmit data to one or more of a central location and an electronic device (¶[0025], ¶[0041], and ¶[0043] the wired or wireless output and input interface 27/47/77 to perform signal transfer and remote monitoring, here, as the wired or wireless output and input interface 27/47/77 is utilized to communicate with a device for remote monitoring, such a device would necessarily be an electronic device as it is capable of receiving signals from the wired or wireless output and input interface 27/47/77; Figs. 1-3 and 6-9).
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.
Claims 3-4, 6, 12-14, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Huang as applied to claims 1 and 10 above, and in view of Hatch (US Patent Application Publication 2020/0085321 – cited by Applicant), hereinafter Hatch.
Regarding Claims 3 and 12, Huang teaches the device of claims 1 and 10 as stated above. Huang further teaches that the user’s breath is monitored for metrics such as period and depth (¶[0010] and ¶[0032]-[0036] the user’s breathing is monitored), but not specifically that the processor is configured to determine one or more of a cellular oxygen supply, a breathing rate, and a breathing effort.
Hatch teaches about an energy conversion monitor (ESM) sensor embedded in an armband for monitoring vitals of users during sleep (see abstract and Figs. 1A-5), including a processor to process recorded data (see ¶[0155]) from light based red and infrared sensors (see ¶[0020]-[0024] and Fig. 2), such that the processor is configured to determine one or more of a cellular oxygen supply (see ¶[0017]-[0018] and ¶[0026]-[0030]), a breathing rate (see ¶[0163] the timing of each breath), and a breathing effort (¶[0018] and ¶[0163]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the cellular oxygen supply, breathing rate, and/or breathing effort determination of Hatch with the optical/light sensor data in Huang because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the cellular oxygen supply, breathing rate, and/or breathing effort determination are additional metrics that would be useful for the user and/or a medical professional providing care for the user; and/or (3) the usage of the ECM sensor to non-invasively detect the timing and relative effort of each breath improves and simplifies the detection of OSA vs. CSA vs. the current PSG system (see ¶[0163]).
Regarding Claims 4 and 13, Huang teaches the device of claims 1 and 10 as stated above. Huang further teaches that the heart beat may be monitored (see ¶[0004] and claim 12), but not specifically to monitor pulse timing to derive one or more of a heart rate and a heart rate variability.
Hatch teaches about an energy conversion monitor (ESM) sensor embedded in an armband for monitoring vitals of users during sleep (see abstract and Figs. 1A-5), including a processor to process recorded data (see ¶[0155]) from light based red and infrared sensors (see ¶[0020]-[0024] and Fig. 2), so as to monitor pulse timing to derive one or more of a heart rate and a heart rate variability (see ¶[0143] and ¶[0185], heart rate and heart rate variability may be monitored; Fig. 13C).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the heart rate and/or the heart rate variability determination of Hatch with the optical/light sensor data in Huang because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the heart rate and/or the heart rate variability determination are additional metrics that would be useful for the user and/or a medical professional providing care for the user.
Regarding Claims 6 and 14, Huang teaches the device of claims 1 and 10 as stated above. Huang does not specifically teach that the power source (i.e., the battery) is one or more of removable and rechargeable.
Hatch teaches about an energy conversion monitor (ESM) sensor embedded in an armband for monitoring vitals of users during sleep (see abstract and Figs. 1A-5), including a processor to process recorded data (see ¶[0155]) from light based red and infrared sensors (see ¶[0020]-[0024] and Fig. 2), that has a power source that is one or more of removable and rechargeable (¶[0111] the power source is a battery that is rechargeable).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the rechargeable battery of Hatch with the battery in Huang because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) rechargeable battery would allow the device to be reused without needing to replace the battery or the device.
Regarding Claim 21, Huang teaches a method of monitoring health by way of a belt with a stress sensing sensor (see abstract and Figs. 1-10). Huang teaches a method (see abstract and ¶[0025]-[0030]) of operating a breathing assistance device (¶[0025], ¶[0041], and ¶[0043] the wired or wireless output and input interface 27/47/77 to perform signal transfer and remote monitoring, the device, ¶[0010] and ¶[0025]-[0030] the guide/instructions sent to the user via an output device, such as via a speaker, as the output device is guiding the user’s breathing, such a speaker would fall under the BRI of a breathing assistance device) in combination with a breathing effort sensing apparatus (see abstract, ¶[0025], ¶[0041], ¶[0043], and ¶[0046] the combinations of the embodiments, including the wired or wireless output and input interface 27/47/77, as Huang teaches the elements required for the breathing effort sensing apparatus, Huang teaches the breathing effort sensing apparatus as currently required in the claims; Figs. 1-10) comprising:
providing a breathing effort sensing apparatus (see abstract, ¶[0025], ¶[0041], ¶[0043], and ¶[0046] the combinations of the embodiments, including the wired or wireless output and input interface 27/47/77, as Huang teaches the elements required for the breathing effort sensing apparatus, Huang teaches the breathing effort sensing apparatus as currently required in the claims; Figs. 1-10) comprising:
a housing with an upper surface, a lower surface and four side walls defining an interior chamber (see ¶[0041] and Figs. 6-8, the sensor/locking head 4 are surrounded by four rounded sides, and an upper and lower surface; see also ¶[0044] and Fig. 10, the interior surrounded by the shell 50);
an armband securable to the housing (¶[0038] the belt for binding to the body of the user, to different body parts including the front arm, wrist, elbow, and upper arm, ¶[0025], ¶[0041], and ¶[0043] the stress sensor 23/43 to receive tension from the belt; Figs. 1-3 and 6-9);
an optical sensor partially positioned within the housing of the breathing effort sensing apparatus with a sensing surface of the optical sensor facing external to the breathing effort sensing apparatus (¶[0025] and ¶[0041] the additional sensor 26/46, such as for light; Figs. 6 and 8);
a tension sensor positioned within the housing wherein the tension sensor receives tension information from the arm band (¶[0025], ¶[0041], and ¶[0043] the stress sensor 23/43 to receive tension from the belt; Figs. 1-3 and 6-9);
a processor positioned within the housing configured to receive information from the optical sensor and the tension sensor (¶[0025] and ¶[0041] the printed circuit board component 24/44, ¶[0043] which includes the microprocessor 70, which receives sensor values from the analog digital conversion interface 72; Figs. 1-3 and 6-9);
a transmitter positioned within the housing configured to receive information from the processor and transmit the information to an external device (¶[0025], ¶[0041], and ¶[0043] the wired or wireless output and input interface 27/47/77 to perform signal transfer and remote monitoring; Figs. 1-3 and 6-9); and
a power source (¶[0025], ¶[0041], and ¶[0043] the PCB 24/44 has power supplied via the battery 45/75; Figs. 1-3 and 6-9),
providing a breathing assistance device in communication with the breathing effort sensing apparatus and transmitting data from the breathing effort sensing apparatus to the breathing assistance device (¶[0025], ¶[0041], and ¶[0043] the wired or wireless output and input interface 27/47/77 to perform signal transfer and remote monitoring, the device, ¶[0010] and ¶[0025]-[0030] the guide/instructions sent to the user via an output device, such as via a speaker, which would necessitate data being sent, as the output device is guiding the user’s breathing, such a speaker would fall under the BRI of a breathing assistance device).
Huang teaches the usage of a light sensor, but not specifically to detect an absorption of red light and an absorption of infrared light via the breathing effort sensing apparatus and determining one or more of a cellular oxygen supply, a breathing rate, and a breathing effort via the breathing effort sensing apparatus.
Hatch teaches about an energy conversion monitor (ESM) sensor embedded in an armband for monitoring vitals of users during sleep (see abstract and Figs. 1A-5), including a processor to process recorded data (see ¶[0155]) from light based red and infrared sensors, so as to detect an absorption of red light and an absorption of infrared light via the breathing effort sensing apparatus (see ¶[0020]-[0024], ¶[0136]-[0138] and Figs. 2 and 10A-10D, ¶[0017] note that the 685 nm is red and the 850 nm is infrared), such that the processor is configured to determine one or more of a cellular oxygen supply (see ¶[0017]-[0018] and ¶[0026]-[0030]), a breathing rate (see ¶[0163] the timing of each breath), and a breathing effort (¶[0018] and ¶[0163]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the red and infrared absorption monitoring of Hatch for the optical/light sensor in Huang because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) Huang requires an optical/light sensor implementation and Hatch teaches one such implementation; and/or (3) utilizing red and infrared light (i.e., via PPG) is a well known modality in the art for monitoring heart rate.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the cellular oxygen supply, breathing rate, and/or breathing effort determination of Hatch with the optical/light sensor data in the modified Huang because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) the cellular oxygen supply, breathing rate, and/or breathing effort determination are additional metrics that would be useful for the user and/or a medical professional providing care for the user; and/or (3) the usage of the ECM sensor to non-invasively detect the timing and relative effort of each breath improves and simplifies the detection of OSA vs. CSA vs. the current PSG system (see ¶[0163]).
Regarding Claim 22, Huang in view of Hatch teaches the method of claim 21 as stated above. Huang further teaches the data transmitted from the breathing effort sensing apparatus includes instructions to control the breathing assistance device (¶[0025], ¶[0041], and ¶[0043] the wired or wireless output and input interface 27/47/77 to perform signal transfer and remote monitoring, the device, ¶[0010] and ¶[0025]-[0030] the guide/instructions sent to the user via an output device, such as via a speaker, as the output device is guiding the user’s breathing, such a speaker would fall under the BRI of a breathing assistance device, as the speaker is outputting sound to the user, it would necessarily receive instructions to emit said sound).
Regarding Claim 23, Huang in view of Hatch teaches the method of claim 21 as stated above. Huang further teaches the data transmitted from the breathing effort sensing apparatus is processed by the breathing assistance device (¶[0025]-[0030] and ¶[0043] the processor 70 analyzes the data and sends the information to the wired or wireless output and input interface 77 for transmission to the external device, such as the speaker) to control operation of the breathing assistance device (¶[0025], ¶[0041], and ¶[0043] the wired or wireless output and input interface 27/47/77 to perform signal transfer and remote monitoring, the device, ¶[0010] and ¶[0025]-[0030] the guide/instructions sent to the user via an output device, such as via a speaker, as the output device is guiding the user’s breathing, such a speaker would fall under the BRI of a breathing assistance device).
Regarding Claim 24, Huang in view of Hatch teaches the method of claim 21 as stated above. Huang further teaches the step of transmitting the data to one or more of a central location and an electronic device (¶[0025], ¶[0041], and ¶[0043] the wired or wireless output and input interface 27/47/77 to perform signal transfer and remote monitoring, here, as the wired or wireless output and input interface 27/47/77 is utilized to communicate with a device for remote monitoring, such a device would necessarily be an electronic device as it is capable of receiving signals from the wired or wireless output and input interface 27/47/77; Figs. 1-3 and 6-9).
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Huang as applied to claim 1 above, and in view of Goodman (US Patent Application Publication 2003/0036685), hereinafter Goodman.
Regarding Claim 5, Huang teaches the device of claim 1 as stated above. Huang further teaches that the heart beat may be monitored (see ¶[0004] and claim 12), but not specifically to monitor pulse amplitude to derive one or more of a mean pulse amplitude and a pulsus paradoxus variation.
Goodman teaches a health monitoring and biofeedback system utilizing a PPG sensor (i.e., an optical sensor) to analyze and determine a plurality of cardiovascular indices from a digital volume pulse (DVP) derived from the PPG pulse contour (see abstract and Fig. 1), so as to monitor pulse amplitude to derive one or more of a mean pulse amplitude and a pulsus paradoxus variation (¶[0208]-[0209] the DVP may be utilized to determine mean pulse amplitude; Fig. 15A).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the mean pulse amplitude cardiac index determination of Goodman with the optical/light sensor data in Huang because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the mean pulse amplitude is an additional metric that would be useful for the user and/or a medical professional providing care for the user; and/or (3) the mean pulse amplitude may also be utilized to correlate to the user’s blood pressure, providing an additional metric (see Goodman ¶[0208]-[0209]; Fig. 15A).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D. MORONESO whose telephone number is (571)272-8055. The examiner can normally be reached M-F: 8:30AM - 6:00 PM, MST.
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791