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
Acknowledgment is made of applicant’s claim for foreign priority to Application No. (AU2020902011) filed on the June 17, 2020.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: breathing apparatus reference “100” is not in the Figures. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“This application is a 35 U.S.C. 371 National Phase Entry Application from PCT/AU2021/050626, filed June 17, 2021, which claims priority to Australian Patent Application No. 2020902011, filed June 17, 2020, which are incorporated herein by reference in their entireties.”
Examiner suggest replacing this paragraph with “This application is a 35 U.S.C. 371 National Phase Entry Application from PCT/AU2021/050626, filed June 17, 2021, which claims priority to Australian Patent Application No. 2020902011, filed June 17, 2020.”
Examiner notes that the filing date of the PCT is the filing date for the national stage application. Therefore, any amendment that comes in with or after the filing of the national stage application in the US is not part of the original disclosure. Per MPEP 608.01(p)(I)(B) states that to be effective an incorporation by reference statement must be filing at time of filing and cannot be added after an application’s filing date. Since a 371 application’s filing date is the date the PCT was filed, an amendment in the 371 application to add an incorporation by reference is not effective and improper as new matter.
Appropriate correction is required.
The use of the term Bluetooth in paragraph 78, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1 and 20 objected to because of the following informalities:
Regarding Claim 1, line 4, "a patient" should read as "the patient".
Regarding Claim 20, line 4, "a patient" should read as "the patient".
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 1, 12, 17, 20 and its dependencies (2-11, 13-16, 18 and 19) 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.
Regarding Claim 1 and 20, the claims recite “wherein respiratory gases of a patient are directed over the sensing assembly” in line 3-4. For the purpose of Office Action, the term “over” is interpreted to mean alongside. In the instant specification, it is not clear what the applicant is claiming because the only references of over the sensing assembly is when the applicant is using the same language as the claim limitations. In paragraph 0147, the applicant states that the substantially enclosed cavity must allow fluids and in particular respiratory gases, to enter and thus pass over the PCB140 and sensing assembly; however, the specification does not go into detail how it goes “over” the sensing assembly nor does the drawing exhibit that. Also, when looking at Figure 1 of the instant application, it seems as the air flows “under” 144/143 and does not flow over or on top of 143/144.
Regarding Claim 12, the claim recites “wherein if a change in the relative humidity during the breath, the state further comprises one of the following: iii. no change in the relative humidity during the breath”. It is unclear how a change is determined and then no change is the relative humidity is determined. Examiner is interpreting that the applicant means at a later time the change is checked again to determine if there is no change.
Similarly, to Claim 12, Claim 17 recites “wherein if a change in the relative humidity during the breath, the state further comprises one of the following: iii. no change in each of the humidity and temperature during the breath”. It is unclear how a change is determined only in the relative humidity and then no change is the humidity and temperature is determined. Examiner is interpreting that the applicant means at a later time a change is checked again to determine if there is no change.
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 idea without significantly more.
The claims recite an apparatus, a method, and a system satisfying two of the statutory categories; therefore, the claims pass step 1 of the eligibility analysis. For step 2A, the claim(s) are directed to a breath detection apparatus for monitoring individual breaths of a patient. The claims recite an abstract idea in the form of determining a state of the relative humidity during the breath and displaying a predetermined visual alert in response to the state of the relative humidity during the breath. This represents a mental processes because it can equivalently be done by a person simply observing the output of a signal of the parameter of the humidity of the breath and determining the state of humidity during the breath and determine a visual alert depending on the state of the humidity of the breath. These are actions that a person could do purely in the mind. If a claim recites a limitation, which under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
Using Claim 1, also applicable to Claims 7 and 20, as a representative example that is applicable to claims 2-6 and 8-19, the abstract idea is defined by the elements of:
Claim 1:
A breath detection apparatus for monitoring individual breaths of a patient, the apparatus comprising:
a sensing assembly comprising a humidity sensor,
the sensing assembly adapted to be connected to an oxygenation device wherein respiratory gases of a patient are directed over the sensing assembly,
the humidity sensor adapted to monitor differences in humidity during a breath of the patient,
wherein the humidity sensor generates an electrical signal representing a humidity level in response to measuring the humidity during the breath;
a processor in electrical communication with the sensing assembly to receive electrical signals generated by the humidity sensor determine a state of the relative humidity during the breath; and a visual display element controlled by the processor and adapted to display a predetermined visual alert in response to the state of the relative humidity during the breath.
Claim 7:
A method for breath detection, the method comprising the steps of:
electronically monitoring a humidity level by a humidity sensor connected to an oxygenation device connected to a patient,
wherein the humidity sensor receives respiratory gases exhaled by the patient and wherein the humidity sensor generates a first electrical signal representing a humidity value in response to measuring the humidity during a breath;
processing the first electrical signal to determine a state of the relative humidity during the breath;
and generating a predetermined visual alert in response to the state of the relative humidity during the breath.
Claim 20:
A breath detection system for monitoring individual breaths of a patient, the apparatus comprising:
an oxygen mask having a ventilation port;
a housing having an opening and a sensing assembly comprising a humidity sensor therein,
the housing positioned over at least a portion of the ventilation port to direct respiratory gases of a patient wearing the oxygen mask into the opening of the housing and over the sensing assembly,
the humidity sensor adapted to monitor differences in humidity during a breath of the patient,
wherein the humidity sensor generates an electrical signal representing a humidity level in response to measuring the humidity during the breath;
a processor in electrical communication with the sensing assembly to receive electrical signals generated by the humidity sensor and determine a state of the relative humidity during the breath;
and a visual display element controlled by the processor and adapted to display a predetermined visual alert in response to the state of the relative humidity during the breath.
The above bolded limitations recite an apparatus, a method, and a system for monitoring the individual breaths of a patient, determine a state of the relative humidity during the breath, and displaying a predetermine visual alert in response to the state of the relative humidity during the breath, that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. The process of measuring an electrical signal representing a humidity level in response to measuring the humidity during the breath, determining the state of humidity during the breath, and generating an alert can be carried out in a person’s mind. This is further defining the abstract idea.
Furthermore, this is a process known to be capable of being performed by people mentally, and not limited to be carried out via computer for automation. People (patients or doctor or caregivers) are capable of measuring through observations an electrical signal representing a humidity level in response to measuring the humidity during the breath, and are able to determine the state of humidity during the breath, generate an alert. This is further defining mental process in the form of observations, evaluations, judgments, and opinions.
Looking at signal of humidity and determining the state of humidity can be carried out manually. This is considered longstanding practice that is the focus of the (patent ineligible) claimed invention and is further defining the abstract idea. The mere nominal recitation of “processor”, “a humidity sensor,” “an oxygenation device”, “ housing”, “oxygen mask, “ ventilation port”, and “visual display element”, does not take the claim out of the group of mental processes.
This judicial exception is not integrated into a practical application (2nd prong of eligibility test for step 2A) because the additional elements of the claim amount to the use of “a humidity sensor,” which is used for extra solution data gathering and high-level of generality as stated in US 20090136788 A1 (para. 0006). Additionally, the use of “an apparatus,” and “housing” and “oxygenation device, “oxygen mask and ventilation port”, are field of use and/or extra solution activity these are merely being used as a tool to execute the abstract idea, see MPEP 2106.05(f). For example, “an apparatus,” and “housing” of high-level of generality shown in US 20090288663 A1 (para. 0002). Also, “oxygenation device” and “oxygen mask and ventilation port” shown that they are conventional and well-known in the art by US 20150196723 A1 (para. 0009). In addition, the use of “processor” and “visual display element” has limitations that are not indicative of integration into a practical application because they are being recited at a high-level of generality as shown in US 20170182267 A1 (para. 0148) (i.e., as a generic processor performing a generic computer function of communicating data between users) or US 20120118291 A1 (para. 0010; Examiner notes: that display/visual display elements are used for display and date entry) such that they amount no more than mere instructions to apply the exception using a generic computer component. This is indicative of the fact that the claim has not integrated the abstract idea into a practical application and therefore the claim is found to be directed to the abstract idea identified by the examiner.
A “humidity sensor” and “sensing assembly”, which is used for extra solution data gathering; “processor” and “visual display element” are general purpose computers and displays; and “an oxygenation device”,” are filed of use or extra solution activity that are also recited in Claim 7, are all considered nothing more than a general link to a technological environment and generic computing devices to perform generic communicating functions such as storing data and instructions, transmitting and receiving data between computers. The “processor” and “visual display element” are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of communicating data between users) such that they amount no more than mere instructions to apply the exception using a generic computer component; for example, the additional elements are directed to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Thus, the claim is directed to an abstract idea identified by the examiner.
For step 2B, the independent claim(s) Claims 1, 7, and 20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than simply instructing one to practice the abstract idea by using a computer to carry out the steps that define the abstract idea. This does not render the claims as being eligible. See MPEP 2106.05(f). The additional elements did not add significantly more to the abstract idea because they were simply applying the abstract idea on a computer without any recitation of details of how to carry out the abstract idea. The rationale set forth for the 2nd prong of the eligibility test above is also applicable to the entirety of the claims. The processor and control computer are generic computer systems and the ventilation system and breathing apparatus are drawn to a field of use.
Likewise, the rationale set forth for the 2nd prong of the eligibility test above for claim 1 is also applicable to Claim 2-6 and 17.
In regards to Claims 2-4, the applicant is reciting the claim recites a new additional element of “housing” that further limit the claims to housing adapted to connect to an oxygenation device, the housing having the sensing assembly located therein and adapted to be in fluid communication with the oxygenation device to receive respiratory gases exhaled from the patient to flow over the sensing assembly. The sensing assembly is adapted to monitor difference in humidity and that it only has humidity sensor. This is further defining the abstract idea identified by the examiner. The same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 5-6 and 17, the claim recites a new additional element of “temperature sensor” which is routine and conditional using as shown in US 20140283829 A1 (para. 0057). Further, wherein the sensing assembly comprises only the humidity sensor and the temperature sensor. Then, determining if a change in each of the humidity and temperature during the breath; or b. no change in each of the humidity and temperature during the breath, wherein if a change in the relative humidity during the breath. The same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 8-9, 11-15, and 19, the applicant is reciting elements that further limit the claims to include wherein the step of generating a first electrical signal representing the humidity value in response to measure the humidity during a breath further comprises the step of measuring a first humidity level during the breath at a first time; and measuring a second humidity level during the breath at a second time. Then, comparing the first humidity level with the second humidity level to determine the state of the relative humidity during the breath, wherein comparing the first humidity level with the second humidity level comprises subtracting the first humidity level from the second humidity level. Further, determining if there is a change or not, if there is change what type of change is it. Then doing the same steps for the temperature sensor herein the temperature sensor generates a second electrical signal representing the temperature level in response to measuring the temperature of the breath of the patient; processing the first and second electrical signals to determine a breathing state during the breath; and generating the predetermined visual alert in response to the breathing state during the breath. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 7 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 10 and 16, the applicant is reciting elements that further limit the claims to include herein the second time is after the first time, and wherein the second time is no greater than 500ms after the first time, or the second time is between 100ms and 500ms after the first time, or the second time is between 150ms and 400ms after the first time, or the second time is between 200ms and 300ms after the first time, or the second time is no greater than 250ms after the first time, or the second time is 250ms after the first time. Additionally, wherein the step of comparing each of the first humidity and temperature levels with the corresponding second humidity and temperature levels to determine the breathing state during the breath occurs every 250ms. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 7 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures | LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). MPEP 2106.05(f)(2).
In regards to Claims 18-19, the claim recites a new additional element of “a wireless communication device” which is routine and conditional using as shown in US 20120150327 A1 (para. 0039). Further, the wireless communication device is not significantly more for the reasons set forth above concerning the devices as a broad class. For step 2B, the claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than simply instructing one to practice the abstract idea by using a wireless device for transmitting the predetermined visual alert to a display device and wherein the visual display element comprises an electronically controlled light in electrical communication with the processor, and the processor is programmed to activate the electronically controlled light in response to the breathing state or wirelessly transmitting the predetermined visual alert to a display device to perform steps that define the abstract idea. This does not render the claims as being eligible. The same rationale set forth for the 2nd prong of the eligibility test above for claim 1 or 7 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 1, 2, 7, 20 and their dependencies rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 positively recites “the respiratory gases of a patient” in line 3. It is suggested that the language be amended to read --… wherein the respiratory gases of a patient are configured to be directed over..—to overcome the rejection.
Claim 2 positively recites “respiratory gases exhaled from the patient” in line 4. It is suggested that the language be amended to read --… the sensing assembly located therein and adapted to be in fluid communication with the oxygenation device which is configured to receive respiratory gases exhaled from the patient..—to overcome the rejection.
Claim 7 positively recites “a humidity sensor connected to an oxygenation device connected to a patient” in lines 2-3. It is suggested that the language be amended to read --…a humidity sensor connected to an oxygenation device configured to be connected to a patient,..—to overcome the rejection.
Claim 7 positively recites “respiratory gases exhaled by the patient” in lines 3-4. It is suggested that the language be amended to read --… wherein the humidity sensor is configured to receive respiratory gases exhaled by the patient..—to overcome the rejection.
Claim 20 positively recites “the housing positioned over at least a portion of the ventilation port to direct respiratory gases of a patient” in line 3. It is suggested that the language be amended to read --… the housing positioned over at least a portion of the ventilation port and is configured to direct respiratory gases of a patient..—to overcome the rejection.
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5-7, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brodkin et al. (US 20200101254 A1), hereafter as Brodkin.
Regarding Claim 1, Brodkin discloses a breath detection apparatus for monitoring individual breaths of a patient (para. 0002), the apparatus comprising:
a sensing assembly (Fig. 2; 7; 0030-0034, 0038) comprising a humidity sensor (Fig. 2;10 and 27; 0030, 0033),
the sensing assembly adapted to be connected to an oxygenation device (Fig. 1; para. 0006, 0028-0030) wherein respiratory gases of a patient are directed over the sensing assembly (para. 0032, 0038), the humidity sensor adapted to monitor differences in humidity during a breath of the patient (0032, 0038, 0042-0049),
wherein the humidity sensor generates an electrical signal representing a humidity level in response to measuring the humidity during the breath (para. 0008, 0030, 0035, 0038, 0042);
a processor (Fig. 1, 3; 3; para. 0031, 0033, 0034-0035, 0038, 0042-0066) in electrical communication with the sensing assembly to receive electrical signals generated by the humidity sensor and determine a state of the relative humidity during the breath (para. 0038, 0045); and
a visual display (Fig. 3; 18, 20; para. 0035, 0037-0038, 0040, 0048) element controlled by the processor and adapted to display a predetermined visual alert (0057-0059) in response to the state of the relative humidity during the breath (para. 0042-0066).
Regarding Claim 2, Brodkin discloses the breath detection apparatus of claim 1,
wherein the apparatus further comprises a housing (Fig. 1-2; 1) adapted to connect to an oxygenation device (para. 0029),
the housing (Fig. 1-2; 1) having the sensing assembly (Fig. 2; 7; 0030-0034, 0038) located therein and adapted to be in fluid communication with the oxygenation device to receive respiratory gases exhaled from the patient to flow over the sensing assembly (para. 0012, 0032).
Regarding Claim 3, Brodkin discloses the breath detection apparatus of claim 1, wherein the sensing assembly (Fig. 2; 7; 0030-0034, 0038) is adapted to monitor differences in humidity (through the humidity sensor; Fig. 1-2; 10, 27; par. 0042-0066) during an individual exhalation and/or an inhalation of a respiratory cycle (0012, 0032; claim 13).
Regarding Claim 5, Brodkin discloses the breath detection apparatus (para. 0002) of claim 1, wherein the sensing assembly (Fig. 2; 7; 0030-0034, 0038) further comprises:
a temperature sensor (Fig. 2; 9, 17, 26, 36; para. 0030, 0033; claims 1, 10, 13), wherein the temperature sensor adapted to monitor differences in temperature during the breath (para. 0067, 0069, 0074-0076), wherein the temperature sensor generates a second electrical signal representing a temperature level in response to measuring the temperature during the breath (par. 0067);
wherein the processor (Fig. 1, 3; 3; para. 0031, 0033, 0034-0035, 0038, 0042-0066) in electrical communication with the sensing assembly receives the first and second electrical signals generated by the humidity sensor and temperature sensor and determines a breathing state during the breath (para. 0073-0076); and
the visual display element (Fig. 3; 18, 20; para. 0035, 0037-0038, 0040, 0048) is controlled by the processor and adapted to display the predetermined visual alert (0057-0059) in response to the breathing state during the breath (para. 0042-0067).
Regarding Claim 6, Brodkin discloses the breath detection apparatus of claim 5, wherein the sensing assembly (Fig. 2; 7; 0030-0034, 0038) comprises only the humidity sensor and the temperature sensor (Fig. 2; only 9 and 10 are present).
Regarding Claim 7, Brodkin discloses a method for breath detection,
the method comprising the steps of: electronically monitoring a humidity level by a humidity sensor (Fig. 2;10 and 27; 0030, 0033) connected to an oxygenation device (Fig. 1; para. 0006, 0028-0030) connected to a patient,
wherein the humidity sensor receives respiratory gases exhaled by the patient and wherein the humidity sensor generates a first electrical signal representing a humidity value in response to measuring the humidity during a breath (0032, 0038, 0042-0049);
processing the first electrical signal to determine a state of the relative humidity during the breath (para. 0008, 0030, 0035, 0038, 0042); and
generating a predetermined visual alert (0057-0059) in response to the state of the relative humidity during the breath (para. 0042-0066).
Regarding Claim 17, Brodkin discloses the breath detection apparatus of claim 5, wherein the breathing state comprises one of the following (para. 0013-0018):
a. a change in each of the humidity and temperature during the breath;
wherein if a change in the relative humidity during the breath, the state further comprises one of the following:
i. an increase in each of the humidity and temperature during the breath; or a decrease in each of the humidity and temperature during the breath (para. 0013-0018; Brodkin).
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodkin, as applied to claim 1, in view of Alahmadi (US 20190015614 A1).
Regarding Claim 4, Brodkin discloses the breath detection apparatus of claim 1,
Brodkin does not disclose wherein the sensing assembly comprises only the humidity sensor.
However, Alahmadi in the same field of endeavors teaches wherein the sensing assembly (Fig. 1; 100) comprises only the humidity sensor (Fig. 1; 108).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the sensing assembly of Brodkin to include the it only comprising a humidity sensor as taught by Alahmadi as it known in the art that breathing detection apparatus to only have humidity sensors for the purpose of detecting only humidity and not another parameter (para. 0022).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodkin, as applied to claim 7, in view of Hagl (US 20120234078 A1).
Regarding Claim 8, Brodkin discloses the method of claim 7,
Brodkin does not specifically disclose wherein the humidity is measured greater than 3 times a second.
However, Hagl teaches that humidity can be measured over time and at predetermined intervals of 10 ms to a few seconds (para. 0149).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the humidity sensor and processor of Brodkin to be able to measure the humidity greater than 3 times a second as taught by Hagl for the purpose of performing calibration at a predetermined temperature and profile can be formed (para. 0149).
Claim(s) 9, 11-15, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodkin, as applied to claims 1 and 7, in view of Baker et al. (US 20160150981 A1), hereafter as Baker.
Regarding Claim 9, Brodkin discloses the method of claim 7, the step of measuring a first humidity level during the breath at a first time; and measuring a second humidity level during the breath at a second time (Examiner notes: sensor 27 compared the humidity levels (para. 0042)).
However, Brodkin does not specifically disclose wherein the step of generating a first electrical signal representing the humidity value in response to measure the humidity during a breath further comprises the step of measuring a first humidity level during the breath at a first time; and measuring a second humidity level during the breath at a second time.
However, Baker wherein the step of generating a first electrical signal representing the humidity value (para. 0013, 0016-0018) in response to measure the humidity (with temperature/humidity sensor 56; Fig. 4, 11a-11b; para. 0069-0073, 0077, 0078) during a breath further comprises the step of measuring a first humidity level during the breath at a first time; and measuring a second humidity level during the breath at a second time (0079, 0089, 0091-0092, 0096; Examiner notes: for the parameter to be compared it has to be taken at two different times. “second” time being after the “first” time; claim 31).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method/processor of Brodkin to include the wherein the step of generating a first electrical signal representing the humidity value in response to measure the humidity during a breath further comprises the step of measuring a first humidity level during the breath at a first time; and measuring a second humidity level during the breath at a second time by included that the humidity sensor/temperature sensor is near the nostril as taught by Baker for the purpose of improving the reliability of the measurement and detect fluctuations in the raw sensor data to identify a regular pattern, identifying and timing peaks to calculate the rate of the measured parameter. Also, being able to measure this parameter could provide an alert when one or more vital signs deteriorates beyond a healthy norm, for example a norm in line with triage and/or medical procedures (para. 0079, 0089, 0096).
Regarding Claim 11, Modified Brodkin discloses the method of claim 9, wherein the method further comprises the step of comparing the first humidity level with the second humidity level to determine the state of the relative humidity during the breath (para. 0079; Examiner notes: for the parameter to be compared it has to be taken at two different times. “second” time being after the “first” time; claim 31; Baker), wherein comparing the first humidity level with the second humidity level comprises subtracting the first humidity level from the second humidity level (para. 0079, 0087-0089, 0096; Baker; Examiner notes: comparing the two is to detect fluctuation and analyze the data to find the differences in humidity (0079)).
Regarding Claim 12, Modified Brodkin discloses the method of claim 11, wherein the state of the relative humidity during the breath comprises one of the following (para. 0079; Figs. 11a-11b)
a change in the relative humidity during the breath, wherein if a change in the relative humidity during the breath, the state further comprises one of the following: i. an increase in the relative humidity during the breath (para. 0079, 0091; Figs. 11a-b; Examiner notes: when a change happens it either an increase or decrease from the last measurement; Baker).
Regarding Claim 13, Modified Brodkin discloses the method of claim 9, wherein the method further comprises the steps of:
electronically monitoring a temperature level by a temperature sensor (thermocouple 9, 17, 26, 36; para. 0006, 0009, 00123-0018, 0030, 0033, 0038-0039; Brodkin), wherein the temperature sensor generates a second electrical signal representing the temperature level in response to measuring the temperature of the breath of the patient (para. 0038);
processing the first and second electrical signals to determine a breathing state during the breath (para. 0067; Brodkin);
and generating the predetermined visual alert (0057-0059) in response to the breathing state during the breath (para. 0042-0066; Brodkin).
Regarding Claim 14, Modified Brodkin discloses the method of claim 13, wherein the method further comprises the step of measuring: measure two levels of temperature and humidity (para. 0009).
Modified Brodkin does not specifically state measuring the first humidity level at the first time; a first temperature level at the first time; the second humidity level at the second time; and a second temperature level at the second time.
However, Baker specifically teaches state measuring the first humidity level at the first time; a first temperature level at the first time; the second humidity level at the second time; and a second temperature level at the second time (para. 0079, 0089, 0091-0092, 0096; Examiner notes: baker teaches that respiratory rate is measured by sensing the differences between the parameters, so “first” and “second” time of the parameters to be compared).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Brodkin to include the measuring the first humidity level at the first time; a first temperature level at the first time; the second humidity level at the second time; and a second temperature level at the second time.
as taught by Baker for the purpose of health monitoring purposes, wellness monitoring purposes, anxiety monitoring purposes, monitoring respiration rate during the practice of sport/activity/yoga and the like, managing stress and anxiety, and so forth (para. 0096).
Regarding Claim 15, Modified Brodkin discloses the method of claim 14,
wherein the method further comprises the step of comparing each of the first humidity and temperature levels with the corresponding second humidity and temperature levels to determine the breathing state during the breath (para. 0079, 0089, 0091-0092, 0096; Baker),
including subtracting the first humidity level from the second humidity level, and subtracting the first temperature level from the second temperature level (para. 0087, 0089, 0091-0092; Baker).
Regarding Claim 18, Brodkin discloses the breath detection apparatus of claim 1,
wherein the predetermined visual alert is a unique visual alert based on the determined breathing state during the breath (para. 0042-0067; specifically, para. 0042, 0058-0059) .
Brodkin does not specifically disclose the apparatus further comprises a wireless communication device for transmitting the predetermined visual alert to a display device and wherein the visual display element comprises an electronically controlled light in electrical communication with the processor, and the processor is programmed to activate the electronically controlled light in response to the breathing state.
However, Baker teaches the apparatus further comprises a wireless communication device for transmitting the predetermined visual alert to a display device and wherein the visual display element comprises an electronically controlled light in electrical communication with the processor, and the processor is programmed to activate the electronically controlled light in response to the breathing state (para. 0009-0011, 0084; Fig. 7a-7c).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Brodkin to include comprises a wireless communication device for transmitting the predetermined visual alert to a display device and wherein the visual display element comprises an electronically controlled light in electrical communication with the processor, and the processor is programmed to activate the electronically controlled light in response to the breathing state as taught by Baker for the purpose of following the person/patient/casualty as it can be very difficult to communicate such information in a noisy helicopter were verbal communication is difficult or impossible (para. 0011).
Regarding Claim 19, Brodkin discloses the method of claim 7, wherein the method has the predetermined visual alert to a display device (para. 0011; 0042-0066).
Brodkin does not specifically disclose that the predetermined visual alert is wirelessly transmitted to the display device.
However, Baker teaches wirelessly transmitting the predetermined visual alert to a display device (para. 0009-0011, 0084; Fig. 7a-7c).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Brodkin to include wirelessly transmitting the predetermined visual alert to a display device as taught by Baker for the purpose of following the person/patient/casualty as it can be very difficult to communicate such information in a noisy helicopter were verbal communication is difficult or impossible (para. 0011).
Claim(s) 10 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodkin and Baker, as applied to claim 9 and 15, in view of Hagl.
Regarding Claim 10, Modified Brodkin discloses the method of the claim 9, herein the second time is after the first time (para. 0079, 0089, 0091; Baker).
Brodkin does not specifically disclose, and wherein the second time is no greater than 500ms after the first time, or the second time is between 100ms and 500ms after the first time, or the second time is between 150ms and 400ms after the first time, or the second time is between 200ms and 300ms after the first time, or the second time is no greater than 250ms after the first time, or the second time is 250ms after the first time.
However, Hagl teaches that humidity can be measured over time and at predetermined intervals of 10 ms to a few seconds (para. 0149).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the processor of Modified Brodkin to measure the humidity level differences at certain time intervals as taught by Hagl for the purpose of performing calibration at a predetermined temperature and profile can be formed (para. 0149).
Modified Brodkin does not disclose specifically and wherein the second time is no greater than 500ms after the first time, or the second time is between 100ms and 500ms after the first time, or the second time is between 150ms and 400ms after the first time, or the second time is between 200ms and 300ms after the first time, or the second time is no greater than 250ms after the first time, or the second time is 250ms after the first time. Since it has been held by the courts that, the only difference between the prior art and the claims was a recitation of relative time intervals of the claimed device between the two measurements. A comparison of two measurements of humidity level and a device having the claimed relative time intervals would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. [MPEP 2144.04].
It would have been obvious as to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Modified Brodkin to have one of the time intervals of wherein the second time is no greater than 500ms after the first time, or the second time is between 100ms and 500ms after the first time, or the second time is between 150ms and 400ms after the first time, or the second time is between 200ms and 300ms after the first time, or the second time is no greater than 250ms after the first time, or the second time is 250ms after the first time. As, Applicant places no criticality on one particular size of the enclosure (para. 21, 24, 97 of applicant' s specification indicates the claimed range however no significance to one time difference over another is present). Modifying the Modified Brodkin to have the claimed time intervals would not have adverse effects on the performance of the device and thus the changing time between the two measurements levels are measured would not destroy the device. The courts have held that, “where the only difference between the prior art and the claims was a recitation of ranges of the claimed device and a device having the claimed ranges would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
It would have been obvious to one having ordinary skill in the art at the effective filing date the invention to modify the modified Brodkin to include the claimed time intervals between the two measurements of humidity or any parameter because it is well within of the skill art through routine experimentation to discover the optimum or workable ranges to provide an effective measurement of the parameters needed to monitor a patient of the present invention. [MPEP 2144.05(I)].
Regarding Claim 16, Modified Brodkin discloses the method of claim 15,
wherein the step of comparing each of the first humidity and temperature levels with the corresponding second humidity and temperature levels (para. 0012, -0013, 0017, 0091).
Modified Brodkin does not specifically determine the breathing state during the breath occurs every 250ms.
However, Hagl teaches that humidity can be measured over time and at predetermined intervals of 10 ms to a few seconds (para. 0149).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the humidity sensor and processor of Brodkin to determine the breathing state during the breath occurs every certain milliseconds/seconds as taught by Hagl for the purpose of performing calibration a