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
With regards to the 112b for “Claim 9 recites “apparatus configured to continuously monitor and detect a respiration symptom caused by COVID-19 or other lung disease based on synchronized ECG and PCG obtained”, however, it’s unclear what is required by this claim.” The rejection is withdrawn in view of the amendment.
With regards to the 102 rejection under Du the rejection is withdrawn in view of the amendments.
Applicant's arguments filed 12/18/25 have been fully considered but they are not persuasive.
Applicant argues that the Mart reference does not disclose “synchronization circuitry that triggers simultaneous sampling”. Examiner disagrees.
Applicants are first arguing that the quotes they point to mean that the data is sampled asynchronously then synchronized in a report after the fact. However, Applicants are interpreting these citations incorrectly and not in view of the entire disclosure of the reference. For example, with regards to “a clock generator 1827 to synchronize the data and create time-based with all the captured or generated data.”, to synchronize any sampling there must be at least one clock in order to provide processing or sampling at all and everything in a digital system is run off of a clock thus it is not limited to their desired interpretation. Applicant’s argument that having a “clock generator” inherently means that the sampling isn’t done simultaneously is a straw man argument by Applicants imposing their own limitations on the discussion by implying it must be interpreted as Applicants desire and then attacking that interpretation, which is not persuasive. Further, time based reports encompasses both reports based on simultaneously sampled data or data which is synced after the fact so it also does not inherently require their interpretation. The Mart reference discloses the claimed elements contrary to what Applicants argue, which is shown when reading these quotes in view of context of the whole disclosure (more discussion on this below with regards to the “clock drift” quote).
Applicants also argue that managing “clock drift” means that the sensor data in Mart is all gathered and combined after the fact. This is not persuasive. Similar to the previous discussion this is not limited to Applicants interpretation. Applicants are arguing that ensuring timings are synched must mean it’s for combining sensor data after the fact in a time report, but Examiner notes that simultaneous sampling also requires the sensors to be synched (which is what Mart is doing) thus showing their limited interpretation is not the only interpretation. Additionally, Applicants’ argument discussing the citation of Mart about clock drift/timing is directly contrary to what the reference is saying when read in the context of the surrounding discussion. Taking a step back, there are two ways to synchronize data: (what Mart is doing) 1) prospectively, by controlling the timing of samples such that they are collected simultaneously; or (what Applicants argue Mart is reciting ) 2) retrospectively, by correcting the timing of samples by an offset. However, in view of the context of paragraph Applicants are citing from Col 39:21-41, the paragraph is discussing things in real time thus “prospectively”. For one non-limiting example from that paragraph, it discusses dealing with crosstalk which is done during data collection not retrospectively. For the above reasons Applicants arguments are not persuasive.
Applicants next state “Martin uses a central clock generator to apply timestamps to these independent streams to "minimize overall clock drift" and generate "time-based reports."” Examiner disagrees, as discussed above with regard to the mention of “clock drift” and “time reports” reading the quoted portions in view of the context of the rest of Mart as Mart is not timestamping and aligning elements retrospectively (see discussion above). First, with regards to their mention of time stamps in particular, Examiner notes that including “timestamps” during data gathering does not mean that the data is not gathered simultaneously. This is another straw man argument and not persuasive, the different simultaneously sampled gathered data can be time stamped. Examiner also notes that “timestamps” are only mentioned in Martin a few times and are not seemingly related to the “overall clock drift” etc. and as Applicants provide no specific citations for a portion of Mart for their underlying discussion of timestamps Examiner is unsure what in particular Applicants are referencing. When reading Mart in the context of the complete disclosure as discussed previously Mart is disclosing the claimed elements. For the above reasons Applicants arguments are not persuasive.
Applicants also discuss “triggers” and “simultaneous sampling”. First, Examiner notes that the term “triggers” or “trigger” does not appear in Applicants specification. Reading the claim element “trigger” in view of the specification and based on Examiners best understanding the BRI would include starting, initiating, causing to happen or commanding etc. the “simultaneous sampling” (thus Examiner does not believe a 112a is appropriate). To the extent Applicant may be reading elements into this term which are not supported this is not persuasive. Second, contrary to Applicants argument, Mart discloses a “control unit” (i.e. for example 1870 fig. 18) which controls the sensors, for gathering data etc. (i.e. triggers etc.). Furthermore, Mart recites “simultaneously collecting useful data associated with the user's cardiovascular system, respiratory system, and other health metrics.” and the analog-front-ends (AFE) “can provide dedicated signal paths for each analog input channel, enabling true multichannel, simultaneous sampling capabilities.” As such Mart discloses the discussed claimed elements contrary to Applicants arguments. For the above reasons Applicants arguments are not persuasive. To the extent Applicants are restating arguments made previously those arguments are not persuasive for the reasons stated above.
In conclusion, Applicant is making various restatements of the argument that the synchronization is happening retrospectively but when reading the portions of Mart Applicants point to and taking those portions in view of the context of the rest of Mart it is clear that Mart discloses is triggering simultaneous sampling prospectively and discloses the claim elements. Therefore, Applicants arguments are not persuasive.
Applicants next discuss dependent claims and rely on the arguments discussed above; the arguments are not persuasive for the same reasons discussed above.
Claim Objections
Claim 3 are objected to because of the following informalities:
Claim 3 recites “comprising one or more environmental temperature sensor,” Examiner believes it should recite “comprising one or more of an environmental temperature sensor,”.
Appropriate correction is required.
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.
(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) 1-3, 5-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Martin (Ana Martin et al., US 11141129) hereinafter Mart.
Regarding Claim 1, an interpretation of Mart discloses an apparatus (fig. 18) comprising:
a wearable size center container that can be attached to a body (Col 30:19-45, Figs. 1, 6, 9, 18 see also Col 7:51-63, Col 18:42-47, Col 47:4-25);
a plurality of different types of sensors attached to the center container collecting a plurality sets of health signals (Col 5:58-Col 6:19, Col 30:33-45, Col 34:61-Col 35-3, Fig. 18 see also Col 35:33-57, Col 38:52-67, Col 47:4-25), wherein the sensors include at least one or more acoustic-to-electric sensors collecting phonocardiogram (PCG) electrical signal (Col 35:33-57, Fig. 18 see also Col 47:4-25) and one or more electrocardiogram (ECG) sensors (Col 38:52-67, Figs. 18 see also Col 47:4-25);
a control unit mounted in the center container (Col 30:46-Col 31:7, figs.1, 6, 8, Fig. 18 see also Col 30:19-45, Col 47:4-25; 1870 in fig. 18 includes controller, ADCs, AFE, memory etc. ), wherein the control unit includes a synchronization circuitry that triggers (Col 30:46-Col 31:7, Figs. 1, 18 see also Col 30:19-45, Col 47:4-25) simultaneous sampling of the plurality of different types of sensors mounted on the center container to align the measurement timing of the plurality of different types of sensors (Col 30:46-Col 31:7, Col 35:10-23, Col 39:21-31, Figs. 1, 16, 18 see also Col 2:45-48, Col 30:24-33, Col 39:39-47, Col 43:1-43, Col 47:4-25; Examiner notes that the term “triggers” or “trigger” does not appear in Applicants specification thus based on Examiner best understanding in view of the BRI would include starting, initiating or commanding etc. the “simultaneous sampling”. Examiner also notes that to the extent “to align the measurement timing . . .” is the intended use of the device, the device recited is structurally and functionally capable of performing the intended use.); and
a wearable size patch with one or more electrodes (Col 18:42-47, Col 30:19-45, Col 38:52-67, Figs. 1, 6, 9, 18 see also Col 47:4-25), wherein each electrode is connected to the center container (Col 18:42-47, Col 30:19-45, Col 38:52-67, Figs. 1, 6, 9, 18 see also Col 47:4-25).
Regarding Claim 2, an interpretation of Mart further discloses wherein the different types of sensors further comprising: a photoplethysmography (PPG) sensor (Col 37:35-Col38:24, Fig. 18 see also Col 47:4-25), a body temperature sensor (Col 36:41-53, Fig. 18), and an orientation and motion sensor (Col 36:9-40, Fig. 18 see also Col 47:4-25).
Regarding Claim 3, an interpretation of Mart further discloses wherein one or more assistant sessors attached to the center container, comprising one or more environmental temperature sensor (Col 36:41-53, Fig. 18 see also Col 47:4-25).
Regarding Claim 5, an interpretation of Mart further discloses wherein each electrode is connected to the center container with a button-sized metal connector (Col 2:24-44, Col 10:41-Col 11:2, Col 20:44-63 including “The electrode contacts of the electronics module 802 contact electrode pads 876 of the flexible patch 860. Recesses 877 in the receptacle 862 can permit electrode contacts of the electronics module 802 to make contact with electrode pads 876.”, Figs. 2, 5, 8-9, 18 see also Col 20:18-27, Col 30:33-45, Col 47:4-25).
Regarding Claim 6, an interpretation of Mart further discloses a wireless communication circuitry (Col 2:24-44, Col 32:16-Col 33:3, Fig. 18 see also Col 47:4-25), wherein the wireless communication circuitry communicates with one or more smart devices through a wireless network (Col 2:24-44 including “a wireless module for establishing a wireless connection, such as with a user device (e.g., smartphone).”, Col 31:61-Col 32:41 including “For example, the electronics module 1802 may be connected to a smartphone or a healthcare server via a wireless communications interface 1851 to continuously transmit data being captured by the device.”, Fig. 18 see also Col 47:4-25; To the extent this element is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use).
Regarding Claim 7, an interpretation of Mart further discloses wherein the apparatus is configured to monitor multiple vital health signals continuously and wirelessly (Col 5:4-24, Col 31:61-Col 32:41, Fig. 18 see also Col 47:4-25).
Regarding Claim 8, an interpretation of Mart further discloses wherein the apparatus is used in one of different applications comprising in a telemedicine application, in a quarantined environment, within a hospital, and in an operation room (Col 4:22-28, Col 4:54-Col 5:24, Col 31:61-Col 32:41 see also Col 47:4-25; To the extent this element, including “is used in one . . .”, is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use).
Regarding Claim 9, an interpretation of Mart further discloses wherein the control unit configured to continuously monitor a respiration symptom caused by COVID-19 or other lung disease (Col 5:4-24, Col 30:46-Col 31:7, Col 31:61-Col 32:15, Col 38:25-51, Fig. 18 see also Col 4:37-53, Col 47:4-25; Recites continuously monitoring respiration and would “detect” or sense the respiration sound which is a symptom. Examiner notes that the claim does not recite to determine if the it the sound is caused by “by COVID-19 or other lung disease” but merely to “detect” or receive the “sound”/”symptom”/signal which is “caused by”. To the extent this element, including “detect a respiration symptom caused by. . .” is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use) based on the synchronized ECG and PCG obtained (Col 4:29-Col 5:3, Col 5:58-Col 6:19, Col 35:33-57, Col 38:52-67, Fig. 18 see also Col 30:33-45, Col 35:33-57, Col 38:52-67 see also Col 47:4-25; To the extent this element, including “the apparatus is attached to a user. . . caused by . . .” is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use).
Regarding Claim 10, an interpretation of Mart further discloses wherein the apparatus is configured to continuously monitor a heart performance during a pacemaker operation (Col 5:4-24, , Col 31:61-Col 32:41, Fig. 18 see also Col 30:19-Col 31:7, Col 47:4-25; To the extent this element, including “. . . during a pacemaker operation . . .”, is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use), and wherein the heart performance is determined based on synchronized ECG and PCG obtained (Col 4:29-Col 5:3, Col 5:58-Col 6:19, Col 35:33-57, Col 38:52-67, Fig. 18 see also Col 30:33-45, Col 35:33-57, Col 38:52-67, Col 47:4-25; To the extent this element, including “is attached to a patient to continuously monitor . . . during a pacemaker operation . . .”, is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use).
Regarding Claim 11, an interpretation of Mart further discloses one or more convertors connecting to the one or more micro acoustic-to-electric sensors and the array of voltage electrodes, wherein one or more convertors digitizes sensor waveform outputs (Col 35:4-23 see also Col 47:4-25, Figs. 16-18; analog to digital converters (aka ADC) convert analog to digital);
a non-volatile storage that stores the digitized waveforms (Col 8:41-Col 9:6, Col 33:57-Col 34:8 see also Col 47:4-25; Examiner notes it’s generally known that non-volatile memory is memory which maintains its storage without power this includes several of the types recited including ROM); and
a user interface unit that receives one or more user configurations for the apparatus (Col 34:22-60, Col 43:1-25 see also Col 47:4-25; To the extent this element, including “that receives . . .”, is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use).
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.
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 Mart in view of Selvam (Anjan Selvam et al., US 20200367816) hereinafter Selv or, in the alternative, under 35 U.S.C. 103 as obvious over Mart in view of Selv in further view of Shusterman (Vladimir Shusterman, US 20180020931) hereinafter Shus.
Regarding Claim 4, an interpretation of Mart further discloses a configurable push button connected to the control module (Col 34:22-60 including “the user interface 1879 can include buttons, pinhole buttons, slider switches, ultra-miniature tactile switches, and the like”, Fig. 18), wherein the push button is configured to perform an activation button (Col 34:22-60, Col 43:1-25).
An interpretation of Mart may not explicitly recite a button configured to perform a plurality of functions including panic button and event reminder.
However, in the same field of endeavor (medical devices), Selv teaches a button configured to perform a plurality of functions including an activation button, panic button and event reminder ([0101] including "A single button may be configured to perform any number of tasks or functions (e.g., switching between modes, powering on/off the smartwatch 1200 or components, entering a different mode, making user selections, sending communications/alerts, activating applications, requesting information, etc.).", [0129]-[0132] including "In one example, a single button is provided on the outer surface to make the device as simple as possible to use in an emergency situation. A single button may be programmed to operate in different modes").
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the wearable center container, patch, sensors including PCG/ECG/etc. for synchronized data gathering/analysis and an interface including a push button for modifying the operation of the device as recited by Mart to include the push button being used for multiple functions as recited by Selv because it provides the user a simple way of interacting with the device ([0129]). Additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the device as discussed above for Mart and combining it according to known methods with teaching of the multiuse button for the various functions recited by Selv because this is merely combining prior art elements according to known methods to yield predictable results of a push button being used for various recited/known functions.
While Examiner believes Mart in view of Selv discloses using the push button for event reminder. However, if applicant disagrees then for purposes of compact prosecution an in the alternative rejection is included below.
In an interpretation of Mart in view of Selv may not explicitly disclose a button for event reminder.
However, in the same field of endeavor (medical devices), Shus teaches using a button for an event reminder ([0262]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the wearable center container, patch, sensors including PCG/ECG/etc. for synchronized data gathering/analysis and an interface including a multiuse push button for performing multiple functions as recited by Mart in view of Selv to include a function of the push button to be event reminder/triggering the logging of an event as recited by Shus because this is combining according to known methods the specific function as recited by Shus to the device with its various components and functions as recited Mart in view of Selv to have the predicted result of push button performing the multiple functions. Phrased more succinctly combining the elements of Mart in view of Selv with those of Shus as discussed above is merely combining prior art elements according to known methods to yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20180303434 [0049] “simultaneously recorded ECG, PPG, and PCG signals using sensor device 100”, Figs. 4-7
US 20180168473 to Du et al. see NF rejection dated 6/18/25
US 20170119255 see [0045], [0083] including “(d) a memory storing instructions executable on the processor, the instructions, when executed by the processor, performing steps comprising: (i) synchronously acquiring data from the first sensor and the second sensor;”
US 20210085262 see [0021], [0093]-[0094], [0103]
US 20190059748 – [0032] recites determining left ventricular ejection fraction (LVEF) which is an indicator of heart performance using PCG and ECG, [0053] If the ECG and PCG are acquired synchronously, this same decomposition can be applied to the PCG
US 11357439 – discloses event tagging
THIS ACTION IS MADE FINAL. 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.
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/James Moss/Examiner, Art Unit 3792