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 .
Response to Arguments
Concerning the previous § 103 rejections, Applicant’s remarks have been fully considered and are persuasive. However, updated grounds of rejection are made in view of newly cited portions of the Dashevsky reference. The amendments have also necessitated the introduction of new matter rejections under § 112.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7, 10-17 and 20-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, independent claims 1 and 11 have been amended to recite “… an inhalation sensor module comprising at least one sensor operable to communicate with the inspirate sensor, wherein the at least one sensor is configured to detect an inspirate sensor parameter as a function of the inspirate sensor …” There appears to be inadequate support in the originally filed disclosure for the bolded limitations.
The relevant support appears to be found in Para. 54 of the specification, which states (note how the italicized portions below contrast with the bolded portions from the paragraph above): “… inhalation sensor module 716 may include at least an inspirate pressure sensor 724, which is fluidic communication with at least an inspirate 708, for example by way of at least a fluidic channel 712. In some cases, at least an inspirate pressure sensor 716 may be configured to sense and transmit at least an inspirate pressure parameter as a function of a pressure of at least an inspirate 708 …” There is no disclosure of (1) the inhalation sensor module communicating with the inspirate [concentration] sensor, and/or (2) the pressure sensor detecting an inspirate sensor parameter as a function of the inspirate sensor. Rather, the italicized portions of Para. 54 above state that (1) the module 716 is in communication with “at least an inspirate 708” (note: note an inspirate sensor), and (2) the pressure sensor detects an inspirate pressure parameter (note: not an inspirate sensor parameter) as a function of a pressure of the inspirate (note: not as a function of an inspirate sensor).
As such, the claims are rejected for containing new matter. The dependent claims are rejected by virtue of their dependence on a rejected claim (i.e. they also recite the same new matter).
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 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.
Claims 1, 3-7, 10-11, 13-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 11,235,183 to Dashevsky (hereinafter “Dashevsky”) in view of US 2019/0167211 A1 to Everman et al. (hereinafter “Everman”) and US 2019/0090800 A1 to Bosworth et al. (hereinafter “Bosworth”).
Regarding Claims 1 and 11, Dashevsky teaches:
at least a respiratory sensor configured to detect a respiration parameter associated with a user (see e.g. Col. 7 line 66 through Col. 8 line 22);
at least a circulatory sensor configured to detect a circulation parameter associated with the user, wherein the circulation parameter comprises a pulse rate (see e.g. Col. 7 line 66 through Col. 8 line 22; note that Dashevsky teaches “heart rate” which is considered effectively synonymous with pulse rate – alternatively, see the discussion of Everman below);
an inspirate sensor configured to detect a fluid parameter associated with a fluid (see e.g. Col. 43 line 26 through Col. 44 line 29, particularly “Again, much like the flow sensor housing 30, the inhaled gas sensor housing may contain any type or combination of sensors. The most common types of sensors which may be used here are oxygen sensors, carbon dioxide sensors, and temperature sensors. However, many other types of sensors are contemplated for use in the inhaled gas sensor housing, including, but not limited to, sensors for measuring volatile organic compounds, hydrocarbons, pressure, flow rates, and the like”);
an inhalation sensor module comprising at least one sensor operable to communicate with the inspirate sensor, wherein the at least one sensor is configured to detect an inspirate sensor parameter as a function of the inspirate sensor (see e.g. Col. 43 line 26 through Col. 44 line 29, particularly “Again, much like the flow sensor housing 30, the inhaled gas sensor housing may contain any type or combination of sensors. The most common types of sensors which may be used here are oxygen sensors, carbon dioxide sensors, and temperature sensors. However, many other types of sensors are contemplated for use in the inhaled gas sensor housing, including, but not limited to, sensors for measuring volatile organic compounds, hydrocarbons, pressure, flow rates, and the like”);
wherein the inspirate sensor and the inhalation sensor module are operable to be configured for fluidic communication (see e.g. Col. 43 line 26 through Col. 44 line 29, particularly “The sensors may be miniaturized to fit into a single inhaled gas sensor housing 15, or multiple such housings may be attached in series, whereby the gas flows through each of them in turn en route to the breathing mask 10.”);
at least a processor (see e.g. Col. 30 lines 48-55) configured to:
receive the at least a respiration parameter and the at least a circulation parameter (see e.g. Col. 30 lines 48-55);
make at least one determination as a function of at least one of the detected fluid parameter and the detected inspirate sensor parameter (see e.g. Col. 45 lines 42-50: “The processor (not shown) collects and correlates the signals received from the sensors. The processor contains and employs an algorithm (not shown) which uses the signals received from the sensors to calculate various measurements and metrics based on the signals from the sensors (see FIG. 7). Those measurements and metrics are then parsed to identify a dangerous physiological condition that is presently occurring, or more preferably to predict the onset of such a condition”); and
identify an imminent loss of consciousness event associated with the user as a function of the at least a respiration parameter and the at least a circulation parameter (see e.g. Col. 7 line 66 through Col. 8 line 22; Col. 9 line 37 through Col. 10 line 2; and Col. 31 lines 33 through Col. 32 line 42);
at least a user interface configured to alert the user as a function of the imminent loss of consciousness event (see e.g. visual display 605 and/or 705; also see the general description of “alerts,” “alarms” and “warnings” throughout the disclosure).
Dashevsky fails to specifically teach that the user interface comprises a bone-conducting transducer. Another reference, Everman, teaches a similar invention for evaluating the condition of a pilot and providing an alert before an imminent loss of consciousness (e.g. see Para. 19: “Embodiments of the disclosed device may provide users such as pilots, firemen, and divers who are operating under extreme circumstances with an early warning regarding potential crises such as loss of consciousness, affording the user a few precious extra seconds to avert disaster …”), including providing the alert via a bone-conducting transducer (see e.g. Para. 19: “Alarms may be provided to the user via bone-conducting transducers or by integration into displays the user is operating, increasing the likelihood that the user will notice the warning in time.”; also see Para. 54, 56, 60 and 77 which also refer to the bone-conducting transducer). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Dashevsky to further include a bone-conducting transducer for providing the alert, as taught in Everman, because it would help ensure that the alert is noticed by the user/wearer in time prior to losing consciousness, e.g. “affording the user a few precious extra seconds to avert disaster” and “increasing the likelihood that the user will notice the warning in time” as explained by Everman in Para. 19, and/or because Everman demonstrates that this was a known mechanism for providing a haptic alert, and thus the modification would merely involve adapting/copying a known suitable alert mechanism from one reference into another similar reference for essentially the same purpose.
Concerning the circulation parameter being a “pulse rate,” Dashevsky is considered to teach this as discussed above. However, Everman teaches collecting pulse rate specifically (see e.g. Para. 24 and 43-44) and, as noted above, teaches a similar invention for evaluating the condition of a pilot and providing an alert before an imminent loss of consciousness (e.g. see Para. 19: “Embodiments of the disclosed device may provide users such as pilots, firemen, and divers who are operating under extreme circumstances with an early warning regarding potential crises such as loss of consciousness, affording the user a few precious extra seconds to avert disaster …”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Dashevsky to collect pulse rate because Everman demonstrates that this is relevant physiological information for predicting dangerous health conditions including loss of consciousness in situations such as monitoring a pilot, and thus collecting it would advantageously help predict a dangerous condition such as loss of consciousness.
Concerning the generation of trend analyses for the respiration parameter and for the pulse rate, and then comparing the trend analyses for imminent loss of consciousness prediction, Everman teaches that multiple parameters are compared to predict loss of consciousness (see e.g. Paras. 42-44) and teaches that trends of parameters may be used to predict a dangerous condition (see e.g. Para. 48: “a physiological alarm condition may be detected when a set of alarm parameters are trending in a way associated with decreases in blood oxygen, causing a blood oxygen warning to be generated before any decrease in blood oxygen is detected”). Note that this demonstrates that Everman possesses the ability to determine trends in the collected physiological data. Furthermore, another reference, Bosworth, teaches a system for monitoring flight crew including pilots and which collects various physiological data using sensors (see e.g. Paras. 135-137 discussing vital sensors) in which trends of collected data may be used to automatically predict health events including loss of consciousness (see e.g. Para. 139: “The historic aircrew health data and associated trends may be used by the health controller 602 to detect and/or predict health events (e.g., loss of consciousness, heart attack, etc.)). Considering these teachings together, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Dashevsky to determine trend analyses for each of the respiration and pulse rate data, and then compare them to help predict an imminent loss of consciousness event, because doing so would advantageously help detect an imminent loss of consciousness event even sooner compared to only evaluating physiological data at a single point in time.
Regarding Claims 3 and 13, Dashevsky teaches a wide range of physiological (and other) sensor types as already discussed above, but fails to specifically teach a near-infrared spectroscopy (“NIRS”) sensor. However, this is an extraordinarily well-known type of sensor for collecting relevant physiological data in this context. For example, Everman teaches a similar invention for evaluating the condition of a pilot (for example) including a NIRS sensor (see e.g. Para. 29 of Everman”). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Dashevsky to include a NIRS sensor, as taught by Everman, because it would amount to a merely simple substitution and/or addition of a known sensor performing its known capability for collecting clearly useful and relevant physiological information.
Regarding Claims 4 and 14, see e.g. Col. 9 line 37 through Col. 10 line 2 of Dashevsky.
Regarding Claims 5 and 15, see e.g. Col. 7 line 66 through Col. 8 line 22; Col. 9 line 37 through Col. 10 line 2; and Col. 31 lines 33 through Col. 32 line 42 of Dashevsky.
Regarding Claims 6 and 16, see e.g. Col. 8 lines 47-48 (“…accelerometers, gyroscopes …”); Col. 32 lines 28-30 (“… peak G loads, as well as G-Load integrals under the appropriate time window can also be considered for the feature vector …”); also see Col. 30 lines 27-47 and Col. 39 lines 19-56 of Dashevsky.
Regarding Claims 7 and 17, see e.g. “G-LOC” in Col. 9 line 41, Col. 30 line 63, Col. 31 line 51 of Dashevsky.
Regarding Claims 10 and 20, see e.g. Col. 49 line 57 (“… audio signal broadcast …”) and Col. 50 lines 48-49 (“… an auditory signal or message …”) of Dashevsky.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Dashevsky in view of Everman and Bosworth as applied to claims 1 and 11 above, and further in view of US 2017/0351828 A1 to Cronin et al. (hereinafter “Cronin”) and/or US 2016/0066808 A1 to Hijazi (hereinafter “Hijazi”).
Regarding Claims 2 and 12, Dashevsky as modified above teaches the inventions of claims 1 and 11 including a wide range of physiological (and other) sensor types as already discussed above, but fails to specifically teach both master and slave circulatory sensors wherein the processor merges the parameters of both sensors. However, this configuration and technique was already well known in the art of physiological sensing. For instance, Cronin teaches this configuration of a master sensor and one or more slave sensors that can be merged (see e.g. Para. 43 of Cronin); Hijazi also teaches this configuration and technique (see Para. 66 of Hijazi). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Dashevsky to include both master and slave versions of any one or more of the sensor types (e.g. including any of the circulatory sensor types, and/or other types), and to merge readings from both the master and slave versions, as taught by Cronin and/or Hijazi, because doing so would provide various predictable benefits such as enhancing the accuracy of the readings as explained by Cronin and/or Hijazi (e.g. by allowing readings to be taken from multiple body locations).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Dashevsky in view of Everman and Bosworth as applied to claims 1 and 11 above, and further in view of US 2009/0088606 A1 to Cuddihy et al. (hereinafter “Cuddihy”) and/or CN 113616167 A to Yin (hereinafter “Yin”).
Regarding Claims 21-22, Dashevsky as modified above teaches claims 1 and 11, including the trend analysis of an imminent loss of consciousness event as explained above, but fails to teach that the trend analysis includes a MACD value comprising both a short-term trend and long-term trend associated with the event (note: by definition, MACD necessarily includes comparison of moving averages of two time periods of different lengths, the shorter of which can be considered “short-term” and the longer of which can be considered “long-term”; the Yin reference below shows how to calculate it). However, MACD was a known statistical technique/algorithm to be used for trending data analysis. For example, attention is directed to Cuddihy which teaches that MACD is one of a variety of known statistical analysis techniques that can be used to monitor physiological data trends and adjust alert limits (see Para. 27 and claim 26). Similarly, Yin teaches that MACD can be used to evaluate physiological data trends and explains how to calculate it using two time periods of differing length (see explanation of MACD on page 5 of the attached translation). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Dashevsky to generate a trend analysis for the loss of consciousness event using MACD because Cuddihy and/or Lin demonstrate that this was a known suitable technique for analyzing trends in physiological diagnostic data.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tripp, Jr. et al. (H1039): considered to be generally relevant; see FIGS. 1-2 and the abstract and Col. 6 lines 37-52;
Melker et al. (US 2008/0058621 A1): considered to be generally relevant; see FIG. 4 and the abstract;
White et al. (US 2013/0281871 A1): see Para. 70 teaching MACD for trend analysis of physiological data.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792