DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Applicant is advised that should claim 18 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1-11 and 16-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see
this section of the MPEP for additional information.
First, the broadest reasonable interpretation of the claim as a whole is
established:
Claims 1, 16, and 21 are directed to a system, device, method, and computer readable medium for measuring temperature of inhaled and exhaled air at a nose, and outputting or determining a respiration rate, core body temperature, or ambient room temperature from the.
Claims 2-4, 17-20, 22-24 include additional sensed data such as ambient temperature, pulse oximetry, and skin temperature.
Claims 5-6 adds a transmission connection.
Claims 8-11 add relative locations of general purpose computer components in a distributed system.
Step 1 of the analysis is the question: “Is the claim to a process, machine,
manufacture, or composition of matter?” and the answer is determined to be yes, as the
claims as a whole are directed to a manufacture and a method.
For Step 2, the preliminary question is whether the eligibility of the claim is self-
evident. The answer is determined to be no, as the claim is not immediately self-evident
as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural
phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
While the terms “set forth” and “describe” are thus both equated with “recite”, their
different language is intended to indicate that there are different ways in which an
exception can be recited in a claim. For instance, the claims in Diehr set forth a
mathematical equation in the repetitively calculating step, the claims in Mayo set forth
laws of nature in the wherein clause, meaning that the claims in those cases contained
discrete claim language that was identifiable as a judicial exception. The claims in Alice
Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 1 (and equivalently in claim 16 and 21) recites the following limitations:
“determine, based on the temperature of the inhaled air, and the exhaled air, one or more of: a respiration rate, an estimated core temperature, and an estimated room temperature”.
The above identified elements comprise an explicit claim recitation of an abstract idea. Therefore, rather than merely involve a judicial exception, the claims are directed to the identified judicial exception.
This claim language is identified as an abstract idea, because in MPEP §
2106.04(a)(2) III B. this language is similar to concepts relating to organizing or
analyzing information in a way that can be performed mentally or are analogous to
human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d
1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods
of logic circuit design, comprising converting a functional description of a level sensitive
latch into a hardware component description of the latch. 839 F.3d at 1140; 120 USPQ2d at 1475. Although the patentee argued that the claims were intended to be
used in conjunction with computer-based design tools, the claims did not include any
limitations requiring computer implementation of the methods and thus do not involve
the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The
court therefore concluded that the claims “read on an individual performing the claimed
steps mentally or with pencil and paper,” and were directed to a mental process of
“translating a functional description of a logic circuit into a hardware component
description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea is similar to Synopsys because the
language reads on an individual performing the determinations mentally or with a pencil and paper. They do not require any computer implementation and therefore are directed to a mental process of determining respiration rate, room temperature, and core body temperature through observation of sensor signal and analytical decision-making, and pattern recognition. Further, these calculations are identified as comprising mathematical concepts.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified.
In claim 1, 21: integrated sensor, temperature sensor, processor memory
Claim 2, 13, 17, 22: ambient air temperature sensor
Claim 3, 14, 19, 24: pulse oximeter
Claim 4, 15: skin temperature sensor
Claim 5: transmitting signals
Claim 6: any signal transmission structure, wired, wireless, or electro-optical
Claim 8, 10: patient monitor
Claim 9: smart cable
Claim 12: integrated sensor, adapter for outputting measurements
Claim 16: integrated sensor
The integrated sensor, temperature sensors, processor, memory, pulse oximeter, smart cable, signal transmission, and patient monitor are only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. Therefore the claimed sensor amounts to mere data gathering and considered an insignificant extra-solution activity.
The processor, memory, signal output/transmission, smart cable, and patient monitor appear together to comprise an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter. All of these elements perform only generic computer functions.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception? The additional elements were identified in the above section under Step 2A Prong Two.
The integrated sensor, temperature sensors, processor, memory, pulse oximeter, smart cable, signal transmission, and patient monitor are only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. Therefore the claimed sensor amounts to mere data gathering and considered an insignificant extra-solution activity.
The processor, memory, signal output/transmission, smart cable, and patient monitor appear together to comprise an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter. All of these elements perform only generic computer functions.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-6, 8, 10, 12-13, 15-18, 20-21, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haveri et al. (U.S. Patent Application Publication No. 2019/0175064) hereinafter referred to as Haveri.
Regarding claim 1, Haveri teaches a monitoring system (Abstract), comprising:
an integrated sensor comprising a temperature sensor configured to measure a temperature of inhaled air entering a nasal passage at the application site, and of exhaled air exiting the nasal passage at the application site (¶[0009], ¶[0151]);
a processor (¶[0154]); and
a memory (¶[0169]) that stores instructions, which, when executed by the processor, cause the monitoring system to determine, based on the temperature of the inhaled air, and the exhaled air (¶[0183]) one of more of:
a respiration rate (¶[0146], ¶[0183]).
Regarding claim 2, Haveri teaches the monitoring system of claim 1.
Haveri further teaches wherein the integrated sensor further comprises an ambient air temperature sensor adapted to measure an ambient air temperature at an application site (¶[0086]).
Regarding claim 4, Haveri further teaches the monitoring system of claim 1.
Haveri further teaches wherein the integrated sensor further comprises a skin temperature sensor adapted to measure a temperature of skin (¶¶0142-0143]).
Regarding claim 5, Haveri teaches the monitoring system of claim 1.
Haveri further teaches further comprising a connection configured to transmit signals from the temperature sensor (¶[0148]).
Regarding claim 6, Haveri teaches the monitoring system of claim 5.
Haveri further teaches wherein the connection comprises one or more of:
a wireless link (¶[0148]).
Regarding claim 8, Haveri teaches the monitoring system of claim 1.
Haveri further teaches wherein the memory and the processor are disposed in an intermediary device between the temperature sensor and a patient monitor (¶[0210] pod, element 18).
Regarding claim 10, Haveri teaches the monitoring system of claim 1.
Haveri further teaches wherein the memory and the processor are disposed in a patient monitor (¶[0148] host monitor or client device).
Regarding claim 12, Haveri teaches, an integrated sensor (Abstract), comprising:
an integrated sensor comprising a temperature sensor configured to measure a temperature of inhaled air entering a nasal passage at the application site, and of exhaled air exiting the nasal passage at the application site (¶[0009], ¶[0151]);
an adapter that outputs measurements of the temperature of the exhaled air, and the temperature of the inhaled air (¶[0148]).
Regarding claims 13, 15; and 6, the claims are directed to substantially the same subject matter as claims 2, 4; and 1 and are rejected under substantially the same sections of Haveri.
Regarding claim 17, Haveri teaches the method of claim 16.
Haveri teaches further comprising: measuring an ambient temperature at the application site; and determining the estimated room temperature based on the ambient temperature (¶[0072] ambient air temperature represents the room temperature, in contrast to skin or airflow temperature).
Regarding claims 18 and 20, Haveri teaches the method of claim 16.
Haveri further teaches wherein the measuring of the measuring a temperature of inhaled air entering the nasal passage at the application site, or the measuring the temperature of exhaled air exiting the nasal passage at the application site, or both, are done continuously or continually over time (¶[0146], ¶[0183]).
Regarding claims 21 and 23, the claims are directed to substantially the same subject matter as claims 1 and 18 and are rejected under substantially the same sections of Haveri.
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) 3, 11, 14, 19, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haveri as applied to claims 1, 12, 16, and 21 above, and further in view of Naser et al. (U.S. Patent Application Publication No. 2020/0305760) hereinafter referred to as Naser.
Regarding claim 3, Haveri teaches the monitoring system of claim 1.
Haveri further teaches a pulse oximeter configured to measure oxygen saturation (¶[0209]).
Haveri does not teach the pulse oximeter at the same application site as the nasal sensor for temperature.
Attention is brought to the Naser reference, which teaches a nasal clip pulse oximeter (¶[0073] pulse oximeter in a nasal clip).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the nasal sensor of Haveri to include a nasal pulse oximeter, as taught by Naser, because the nose clip is comfortably worn by a patient during sleep (Naser ¶[0068]).
Regarding claim 11, Haveri as modified teaches the monitoring system of claim 3.
Haveri as modified by Naser further teaches wherein the pulse oximeter sensor and the temperature sensor are physically integrated into a single unit (Naser: ¶[0073] pulse oximeter in a nasal clip).
Regarding claims 14, 19, and 21, the claims are directed to substantially the same subject matter as claim 3 and is rejected under substantially the same sections of Haveri and Naser.
Regarding claim 22, Haveri as modified teaches the tangible, non-transitory computer readable storage medium of claim 21.
Haveri further teaches wherein the instructions, which, when executed by the processor, further cause the processor to: receive an ambient temperature at the application site; and determine the estimated room temperature based on the ambient temperature (¶[0072] ambient air temperature represents the room temperature, in contrast to skin or airflow temperature).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haveri as applied to claims 1, 12, and 21 above, and further in view of Koltowski et al. (U.S. Patent Application Publication No. 2019/0254534) hereinafter referred to as Koltowski.
Regarding claim 7, Haveri teaches the monitoring system of claim 1.
Haveri teaches only thermistors, which Applicant discloses is a relative temperature sensor.
Therefore, attention is brought to the Koltowski reference, which teaches a temperature sensor that does not measure a relative temperature (¶[0170]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the temperature sensor of Haveri to be an absolute temperature sensor, as taught by Koltowski, because Koltowski teaches extremely high accuracy and lowest noise, with highest resolution (Koltowski ¶[0170]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haveri as applied to claim 1 above, and further in view of Abreu (U.S. Patent Application Publication No. 2018/0206730) hereinafter referred to as Abreu.
Regarding claim 9, Haveri teaches the monitoring system of claim 1.
Haveri does not teach wherein the memory and the processor are disposed in a smart cable device connected to the temperature sensor.
Attention is drawn to the Abreu reference, which teaches a smart cable device connected to a temperature sensor (¶[0449]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cable of Haveri to use a serial cable, as taught by Abreu, because they eliminate a need for batteries and their disposal (Abreu ¶[0430]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2016/0245830 to Mace et al. teaches an electro-optical system attachable to a nasal alar.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792