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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/17/24 has been entered.
Response to Arguments
With regards to the drawing objection it is withdrawn in view of the amendments.
With regards to the specification objection for “The disclosure is objected to because of the following informalities: the spec table 3 recites “attitude information” as an environmental information this appears to be a typographical error and meant to recite “altitude”.” It is withdrawn in view of the amendment.
With regards to the objection and 112b to claim 25 for “measure attitude information”, the objection and rejection are withdrawn in view of the amendment to recite “human motion” (aka movement).
With regards to the 112b reciting “Claim 15 recites “a plurality of physiological sensors” and later recites both “the physiological sensors include” and “the plurality of physiological sensors”.” The rejection is withdrawn in view of the amendments, but Examiner notes there is a similar 112b which was created by the amendment.
Applicants’ arguments, see Arguments on Pgs. 9-26, filed 2/11/26, with respect to the rejection(s) of the pending claim(s) under 35 USC 103 have been fully considered and are not persuasive and/or are moot.
To the extent under the different sections Applicants are arguing against the references individually, in response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
To the extent under the different sections Applicants are arguing as if Attorney arguments are facts. Examiner notes that Attorney arguments are not considered facts on the record.
Applicants first start with brief discussion of Applicants technology as viewed by Applicants; Examiner notes this portion does not appear to argue things aren’t taught by references. To the extent Applicants statement of invention and/or arguments are directed to elements which are not claimed; in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “soft earpiece” etc.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
An “ear-mold” does not require it is soft etc.; Examiner also notes that per Applicants specification (using PG Pub for paragraph numbers) [0055] it recites “ear-mold 126 (also referred to herein as an earpiece)” the ear mold is an earpiece. With regards to an “ear-mold”, to the extent Applicants argue “unless a material is soft/compliant, then it cannot be molded” is not persuasive. Therefore, with regards to an “ear mold”, the arguments are not persuasive as an earmold/earpiece can be soft or hard and be molded to shape ears generally or molded to shape a particular person (for one non-limiting example a generically shaped silicone shaped earpiece fitting vs. an epoxy molded earpiece rigid formed to match a specific ear). Examiner also notes that in their discussion they argue it must “soft”, “deform” etc. (they also mention materials such as silicone, rubber etc.) but these elements do not seem to appear in Applicants specification. In conclusion, while Applicants argued version is one possibility the claims are not limited only to that possibility. To the extent Applicants are arguing the amended “ear moldable”, “ear moldable” is narrower than the discussion above of “ear mold” but does not seem to have support in the originally filed claims or specification (see the 112a rejection below regarding ear moldable).
Applicants next generally discuss Tuck, limiting the teaching of Tuck such as arguing it is rigid and inflexible and while this is one version of the housing of Tuck. However, Tuck clearly recites that it can be laid out in various ways and made of a variety of materials and a reference is relevant for all it contains. The Tuck reference discloses the device have various layouts, including the module comprising an earpiece body portion and an ear fitting member; and the housing of the ear module body portion can also include the ear attachment portion. However, Tuck recites that [0054] “The term “earpiece module” includes any type of device that may be attached to or near the ear of a user and may have various configurations, without limitation” and [0124] “A variety of earpiece styles, shapes, and architectures can be used for earpiece module 100 according to embodiments of the present invention.” showing Tuck recognized there are numerous variations of the ear wearable device. Examiner was pointing to the discussion of Tuck describing the earpiece attachment/ear support portion (i.e. the over the ear part) being included in the housing that same portion of Tuck also recites that earpiece attachment portion can include sensors. However, as Tuck acknowledged and Haan was applied for (as well as the references in conclusion section showing the general knowledge in the art) there are numerous styles/layouts for earpieces known in the art. Tuck discloses an earpiece with an earpiece module (with an over ear portion) and an earpiece fitting with a plurality of sensors that can be located within the canal and on the earpiece body/ear support. Applicants specifically argue that earpiece fitting “”fits” but does not “mold”” to the contour of the ear. The earpiece fitting is molded/created/designed/shaped to fit in the ear of a user thus an “ear mold”. Applicants may be arguing this in view of the amendment “ear moldable”, while Examiner maintains the Tuck reference discloses an “ear mold”/earpiece, Tuck may not explicitly disclose earpiece is “ear moldable”/molded to the user’s ear, but again Examiner notes Applicants do not have support for this (see 112a rejection). For the above reasons Applicants arguments are not persuasive.
Next, Applicants appear to be arguing that a portion of the rejection supports their position (“To be sure, and consistent with the Office Action, there is no teaching or suggestion that the earpiece fitting is moldable but instead indicates that it is "largely (an) inflexible unit." (See Office Page 9, Paragraph 4; and Tuck, Paragraph [0075]).”), but the quoted section is referring to a portion of the housing and not the elements relating to the earmold (the earpiece fitting) and this is not persuasive. However this is moot in view of the discussion of the previous paragraph; in view of the amendment “ear moldable”, while Examiner maintains the Tuck reference discloses an “ear mold”/earpiece, Tuck may not explicitly disclose earpiece is “ear moldable”/molded to the users ear, but again Examiner notes Applicants do not have support for this (see 112a rejection).
Applicants next state “Further, there is no teaching or suggestion that the environmental sensors are fitted in the earpiece fitting but instead are preferably located outside of the earpiece.” which confuses Examiner because the earpiece fitting is the portion of the overall earpiece positioned in the ear and based on the claims the environmental portion is not inside the ear (per the claim “coupled to the housing and configured to detect at least one environmental condition, wherein the at least one environmental sensor includes a radiation sensor mounted on the housing and wearable behind the outer ear of the person,”). So, why would Examiner argue that the earpiece fitting inside the ear has environmental sensors when that’s not what’s claimed or relevant? Examiner is a bit confused by this argument as it seems to support the rejection in view of Tuck disclosure that the radiation sensor is on the housing and behind the ear, which isn’t inside the ear but on the ear. Ultimately, Examiner is unsure what exactly applicants are arguing and as such it’s not persuasive. Examiner also notes that, Applicants acknowledge that there are health sensors integrated into “module 1009” the earpiece fitting (Examiner notes that what Applicants point to is not the only discussion of sensors of the earpiece fitting).
Applicants next discuss Haan, Examiner notes that Haan was provided explicitly disclose the claimed layout of the device with a behind the ear (BTE) portion, an elongated portion, and an in the ear portion (ITE). While Tuck clearly disclosed a housing including a BTE portion and an ITE portion, Tuck may not explicitly disclose ITE and BTE are separated with the elongated portion between the ear mold portion and a housing. Hence the combining of the references. Examiner notes that ear wearable devices have several known styles/layouts (see Haan and the US 20130343584 reference (among others) in the conclusion section both of which discuss several alternatives) which include BTE, ITE and combinations of both (RITE, RIC etc.; combinations including an “elongated portion”). Applicants focus on the ITE portion of Haan and argue that while the ITE fits in the ear canal it is “rigid and not moldable or flexible”, but this is not accurate or persuasive. With regards to Haan it recites the ITE part in [0095] including “a flexible guiding element, e.g. a dome-like element”, [0133] including a “dome or mould . . . or micro-mould . . . for guiding and positioning the ITE-part in the ear canal (Ear canal) of the user.” (Examiner notes that mould is being interpreted as a different regional spelling of the same word) and in [0145] includes “ITE-part comprises an ear mould, e.g. adapted to the user's ear”. Thus, the ITE part includes an “ear-mold”/earpiece which is flexible and/or molded/moldable to the user’s ear. Applicants also state that state that “does not need a moldable fit because it is projecting sound into the ear unlike Applicant's technology which senses dermal inner-ear changes in an effort to monitor various physiological, conditions” which is also directly contradicted by Haan. In [0145] it recites “adapted to the user's ear canal to minimize leakage of sound”. Haan, additionally, discloses sensors for physiological signals in the ITE portion including microphones, PPG and/or electric potential sensor etc. (see also Fig. 6, [0156]) which also provides a use for physiological monitoring similar to both Tuck and Applicants claimed invention. The Haan reference includes a molded ear mold with sensors, contrary to Applicants assertions, and the arguments aren’t persuasive. Regardless, in view of compact prosecution goals and to more explicitly show this feature a different reference has been applied (see rejection below).
Examiner is a little bit confused by Applicants last bit of discussion “an effort to modify Tuck's structure by including Haan's housing section behind the outer ear and an elongated member between a housing section and the rigid earpiece module would likely require unnecessary reconfiguration of the Tuck Structure. This proposed combination appears completely unnecessary due to the location of the earpiece fitting and ear attachment 505/alternatively ear support 901/earlobe clip 904. Therefore, Haan is not a combinable reference, and one skilled in the art would not look to Haan to resolve the deficiencies of Tuck in an effort to yield Applicant's claimed invention.” Applicants appear to be arguing that in their view the Tuck reference discloses the elements Haan is applied for thus Haan is moot and “not combinable”. If applicants are attempting to make an admission on the record, please do so more clearly. Examiner notes in discussion under B Applicants explicitly contradict this and recite that Tuck does not recite an “elongated” portion thus contradicting this argument themselves (Examiner notes that the elongated member was seemingly added to overcome the Final rejection dated 9/18/24). However, currently as discussed above with regards to the BTE, ITE and elongated portion Examiner believes the secondary reference is required. Applicants don’t seem to be arguing its non-analogous or against the motivation per se but arguing that it’s not necessary, as Examiner currently believes there is a need for the secondary reference this is not persuasive. For the above reasons these arguments are not persuasive.
(A)
Applicants state “Applicant agrees with the Examiner that Tuck is deficient and does not teach or suggest numerous features of the claimed invention, including the in-ear wearable apparatus is an ear- moldable in-ear wearable apparatus, and at least one of the first of plurality of physiological sensors is integrated into the housing, which is separated from the ear-mold, as recited in claim 1.” However, as this is a new claim element Examiner has never commented on this before. Thus, this argument is not persuasive, see the rejection below.
Applicants next discuss their interpretation of their own device again on page 12 first half of page 13. Examiner again notes that “soft”, “deform”, “moldable” are not recited in the originally filed specification and the “ear-mold” does not provide the level of specificity Applicants are implying for this discussion. Further Applicants’ arguments for benefits (such as “moldability is critical” etc.) provided are not elements recited in the originally filed specification and Attorneys arguments are not facts on the record. The specification does not mention the criticality (“importantly”) applicants are arguing. The only time the term “critical” is recited in their specification is in [0089], and applicants expressly recite advantages, benefits are not critical; “However, benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential feature or element.”. Applicants also state, “where the in-ear sensor 112 is mounted to the ear mold 126 to track various electro-activities occurring within the user's body, including EKG, IMU (accelerometer, gyroscope and magnetometer) and pulse oximetry”. Examiner note “electro” implies sensing electrical elements which IMU and pulse ox are not sensing, EKG (“electrocardiogram”) does. To the extent EKG (or an electrical based sensor) is not claimed for the second plurality of physiological sensors, Applicants are reading in elements which is not persuasive. To the extent Applicants’ arguments mention warfighters, pilots etc. (both in this discussion and in previous and later portions of their arguments), Examiner notes both that these elements are not currently claimed. Additionally, Applicant's argument that they are used for “warfighters” as opposed to “conventional” use is a recitation of the intended use of the claimed invention; and it must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicants again discuss Tuck very similar to the discussion of Tuck above, Applicants recite “Importantly, the Office Action explicitly indicates that the entire earpiece module is a single, large, inflexible unit.” The Tuck reference discloses the device have various layouts, including the module comprising an earpiece body portion and an ear fitting member; and the housing of the ear module body portion also includes the ear attachment portion. However, Tuck recites that [0054] “The term “earpiece module” includes any type of device that may be attached to or near the ear of a user and may have various configurations, without limitation” and [0124] “A variety of earpiece styles, shapes, and architectures can be used for earpiece module 100 according to embodiments of the present invention.”showing Tuck recognized there are numerous variations of the ear wearable device. Examiner was pointing to the discussion of Tuck describing the earpiece attachment/ear support portion (i.e. the over the ear part) being included in the housing that same portion of Tuck also recites that earpiece attachment portion can include sensors; However, as Tuck acknowledged and Haan shows (as well as the references in conclusion section) there are other styles/layouts for earpieces known in the art. With regards to “To be sure, Tuck does not provide any teaching or suggestion that the earpiece fitting 1008 is moldable but instead indicates the opposite. As indicated above, this earpiece fitting 1008 is structurally analogous to a rigid hearing aid-type device that "fits" but does not "mold" to the contour of the ear canal during use unlike Applicant's technology,”, as discussed above, while Examiner maintains the Tuck reference discloses an “ear mold”/earpiece, Tuck may not explicitly disclose earpiece is “ear moldable”/molded to the users ear (Tuck is silent as to whether or not the earpiece fitting is molded specifically to a particular user’s ear).
Applicants next recite “Please note, and unlike Applicant's claimed technology, Tuck does not teach or suggest any electrodes/physiological sensors situated in any housing structure external to the ear canal area for sensing physiological changes resulting from dermal changes of a user at the skin layer”. Examiner disagrees. For example, in [0061] Tuck recites “the region behind the ear (for measuring skin temperature and galvanic skin response)” (GSR is performed using electrodes), [0127]-[0128] “Galvanometry, the measurement of electrical properties of the skin, can be measured . . . conductively, with two, three, four, or more conductivity probes.” (conductivity probes aka electrodes), [0145] separately discusses how electrodes can be integrated into “an earpiece module or connected to an earpiece module”. Examiner notes GSR is also referred to by other terms including electrodermal response (EDR), skin conductance response (SCR), electrodermal activity (EDA), electrodermal level (EDL), or skin conductance level (SCL) as evidenced by the ADInstruments reference and US 20080165017 both recited in the conclusion section. ADInstruments reference also discusses the basics of the GSR signal including “it is possible to measure skin conductance by placing two electrodes on the fingers of human subjects. The measured parameter, know as skin conductance, is expressed in microsiemens (µS).”. Contrary to Applicants argument, Tuck discloses placing physiological sensors at various places outside of the ear canal including electrodes integrated into the housing not on the earpiece fitting (i.e. in the ear canal). For the above reasons Applicants argument is not persuasive. Also, with regards to the discussion of “fighter pilots” see the discussion above, again this is not claimed, and it is an intended use of the device.
Applicants next argue “In significant contrast . . .” that Haan does not disclose the elements discussed. Haan recites physiological sensing on an ear wearable device (see citations below). Haan explicitly recites a ITE being “ear mould” which they explain means “adapted to the user's ear” thus it is molded to the user’s ear. As discussed above, the Tuck reference discloses physiological sensors outside of the ear canal. For further explanation see the above discussion of Tuck. The Haan reference includes a molded ear mold with sensors, contrary to Applicants assertions, and the arguments aren’t persuasive. In view of compact prosecution goals and to more explicitly show the “ear moldable” ear mold feature (as Applicants have argued but do not have 112a support for) a different reference has been applied (see rejection below).
Applicants next discuss Haan with regards to Haan not disclosing physiological sensing outside of the ear, however this is an attack against the reference individually (see discussion of this above) and not the combination of references. Haan was not recited to disclose sensors outside of the ear canal therefore it is not persuasive.
Applicants next argue that Tuck and Haan are not combinable, Applicants argue that “would likely require unnecessary and significant reconfiguration of the Tuck Structure” rendering the reference unable to be combined. However, these are not reasons that the references can’t be combined. The Tuck reference does not disclose the exact layout with the elongated portion between the “housing” and the “ear-mold” as claimed and the secondary reference is provided to disclose that element (for specifics see the rejection below). Thus, this argument is not persuasive.
Applicants further argue “To be sure, Tuck' sensor are located in/adjacent to the earpiece module/ earpiece fitting 1008, whereas Haan's electronics are primarily located in the BTE/housing section separate from the ear piece ITE. Therefore, Haan is not a combinable reference,”. As discussed above the Tuck reference acknowledges there are numerous layouts/styles for ear wearable sensor devices and the combining of the teaching of a specific layout as provided by Haan is obvious combination of references.
To the extent Applicants argument that the elements from the Tuck and Haan references are “teaching away” from each other, this is not persuasive. Per MPEP 2123 and 2141.02(VI) "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also MPEP § 2123. In the current case, neither of the references “criticize, discredit, or otherwise discourage” the combination. Further, Examiner disagrees with Applicants assertion that “it is unlikely” tucks wearable could be redesigned, to work with the alternative layout. As noted previously Tuck explicitly acknowledges there are various alternative layouts thus leading to the conclusion that the inventors recognized there are other layouts that the substation/combination of which would lead to a predictable result. Applicants seem to be arguing that the different layout would render the device uncapable of performing its intended use of sensing etc. but combining the features of Tuck with those relied upon from Haan would still provide a housing with sensors and sensors in the ear canal for monitoring the user, thus not rendering Tuck unsatisfactory for its intended purpose. For the above reasons this is not persuasive.
To the extent the discussion is an analogous art argument, in response to applicant's argument that Tuck and Haan are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Tuck and Haan are related both to the field of the inventor’s endeavor sensor monitoring (physiological and/or environmental) using an ear wearable device; and the problem with which the inventor was concerned putting sensors on an ear wearable device to monitor a user. As such both of the references are analogous art. Examiner notes that prior art for analogous art is related to the “inventors” endeavor or problem.
Applicants next argue “there needs to be motivation at least in the primary reference for one of ordinary skill in the art, that is, for Tuck, to be modified or combined with a secondary reference, such as Haan, and Tuck provides none.” This is not persuasive. This is not the proper analysis, in arguendo if one were to accept Applicants argument on the analysis, the analysis would be stricter than even TSM was before KSR International Co. v. Teleflex Inc. (2007). Based on SCOTUS’ holding in KSR it was clear that such a narrow approach as inferred by Applicants is not what is required; see MPEP 2141 including “The KSR decision reinforced earlier decisions that validated a more flexible approach to providing reasons for obviousness. However, the Supreme Court’s pronouncement in KSR overruled cases such as In re Lee, 277 F.3d 1338, 61 USPQ2d 1430 (Fed. Cir. 2002), insofar as those cases require record evidence of an express reason to modify the prior art.”. Applicants’ argument is a straw man argument, imposing an improper overly narrow interpretation of the “motivation” analysis and then arguing it isn’t met. Contrary to Applicants argument the motivation provided, provides a rationale to combine and the combined elements would obtain a predictable result.
Applicants further seem to be arguing (“this asserted reliance . . .”) the housing structure with sensors for external placement next to an ear is recited by Tuck as discussed above and enumerated in the rejection below. The combination of references discloses connecting housing/sensor structure to an earpiece via an elongate member and the basis is provided in the rejection below. Examiner notes that for “not present in Haan” see the discussion above, Applicants arguments are not persuasive and/or moot as discussed above. For the above reasons these arguments are not persuasive.
Applicants next make a conclusory statement relying on the discussion above and it is not persuasive for the same reasons discussed above.
Applicants next argue that Haan does not teach an “ear moldable” in ear wearable nor does it teach physiological sensors integrated into the housing. As discussed above the Haan reference discloses more than Applicants specification does on an in ear moldable with a dome or ear mold and reciting it can be flexible (see discussion of tuck above rejection below for more specifics). With regards to the physiological sensors integrated into the housing, as discussed above, the rejection is based on the combination of the references and Haan is not relied on for physiological sensors on the housing outside of the ear canal. The Tuck reference discloses sensors outside of the ear canal integrated into the housing. Again, discussion of “pilots” is intended use and not claimed, nor are Attorney arguments facts on the record. Therefore, these arguments are not persuasive.
Applicants remaining discussion in A is a conclusion statement relying on the earlier arguments. Applicants’ arguments are not persuasive (or moot as discussed above) for the reasons discussed above, Tuck in view of Haan discloses the claim elements as discussed above.
With regards to the “ear moldable” element, there is a pattern in Applicants arguments. It appears Applicants are attempting to use Applicants arguments as a foundation to provide support for adding in limitations which are not disclosed in the originally filed specification (see the 112a rejection), this is not persuasive.
(B)
Applicants agree with the Examiner that the Burwinkle (Bur, cited below) does not disclose elements. Examiner notes this statement was directed to the elements as discussed in the previous action. Applicants “asserts that Burwinkel ("Bur") also does not teach or suggest” the “ear-moldable in-ear wearable apparatus” (Examiner notes again there is no support for this in Applicants spec see 112a) and “at least one of the first of plurality of physiological sensors is integrated into the housing”. Examiner notes that Bur was not recited for the “ear moldable” element so the argument is not persuasive and/or moot. Bur was applied for showing a sensor of the first plurality of physiological sensors (see more discussion later in B) and it does disclose this (as well as various other sensing including electrode based sensing such as EMG and GSR sensing see citations in the rejection below) so the argument is not persuasive.
Applicants also argue “Bur is further deficient and also does not teach or suggest other numerous features of Applicant's claimed invention, including the first plurality of physiological sensors include the IMU sensor, the pulse oximetry sensor, the GSR sensor, the EMG Sensor, the EKG sensor, and the EEG sensor., as independently recited in dependent claims 5. (See Application, above).” But Examiner disagrees. Bur discloses an ear wearable device with a plurality of alternative layouts/styles ([0055]). Also as claimed the first plurality of sensors in the housing portion, which is disclosed by the Bur references, see for example [0058], [0074], Fig. 8. Bur was applied specifically for the EMG sensors but as noted for compact prosecution purposes it also discloses the housing integrated with other sensors including IMU sensor, the pulse oximetry sensor, the GSR sensor, the EMG Sensor, the EKG sensor, and the EEG sensor. For these reasons Applicants argument is not persuasive.
Applicants next argue that Bur does not resolve the issues they claim are deficient in Tuck and Haan; Examiner believes this is a reference to the “ear-moldable in-ear wearable apparatus” and “at least one of the first of plurality of physiological sensors is integrated into the housing”. Examiner notes that Bur was not recited for the “ear moldable” element so the argument is not persuasive and/or moot. Bur was applied for showing a specific sensor of the first plurality of physiological sensors (see more discussion later in B) and it does disclose this (as well as various other sensing including electrode-based sensing such as EMG and GSR sensing see citations in the rejection below) so the argument is not persuasive. Examiner notes that Bur recites “health monitoring device”, more specifically an ear wearable sensing device, thus it is analogous to the claimed invention and is similar to those of the other prior art references and the claimed invention. Applicants appear to be arguing that the “sensor package” is adjacent or in the ear canal however this is not persuasive. As discussed above the Bur reference recites the form factor/style of the ear device can vary. The specific example they use to present their elements is similar to that of Haan and has the BTE element with an elongated portion attached to an ITE portion. In this case the BTE portion is recited as having the sensors, see for example 802/814 Fig. 8. For the above reasons these arguments are not persuasive.
In “to be sure . . .”, Applicants bring up “an ear-mold, that is a moldable ear mold” (Examiner notes this statement is more specific than claimed see discussion in the 112b below) which again Bur is not relied on to show and thus this isn’t persuasive. Applicants again state Bur doesn’t disclose the sensors in the housing, see the previous paragraphs, and again this is not persuasive. As mentioned in the previous paragraph Bur discloses a “ear mold” and separated “housing” with an elongated portion between them (figs. 7-8), which is similar in form factor/style to both the claimed invention and Haan. To the extent Applicants appear to be arguing that it doesn’t teach elements for which it is not applied this is not persuasive. For the above reasons Applicants arguments are not persuasive.
In “technically . . .” Applicants seem to state the Bur reference can’t be combined with the Tuck and Haan references. Applicants seem to be arguing they have different purposes, but all the references are related to monitoring using sensors mounted on ear wearable devices, so this is not persuasive. To the extent it’s an analogous argument: as the device is monitoring the user using an ear wearable device it is both in same endeavor of physiological monitoring using an ear wearable device; and the problem with which the inventor was concerned using an ear wearable device to monitor a user. Applicants mention Haan and state it “non-physiological monitoring” Examiner disagrees, see the discussion above regarding Haan and its disclosure of physiological sensing. Applicants seemingly next argue that is not reasonable because a PHOSITA because of the “different functional objectives”. However, Examiner as discussed above disagrees, because each of the devices is a directed to an ear wearable monitoring device. Furthermore, Applicants is not applying the proper analysis. The final paragraph is a conclusory statement which relies on the more in-depth discussion addressed above. For the above reasons Applicants arguments are not persuasive.
Applicants mention of “Tuck is a monitoring system where the sensor package is located in/adjacent to the earpiece module/ earpiece fitting without a housing structure attached to an earpiece via an elongated member.” Contradicts earlier discussion. Examiner notes that in previous arguments discussed above Applicants seemingly argued that the elongated element was not necessary thus arguing that combination of Tuck in view of Haan was improper yet here Applicants state Tuck does not recite an elongated member connecting a housing an earpiece seeming to directly contradict themselves.
(C)
Applicants state they agree with the Examiner that the Sacha reference does not disclose elements. Examiner notes this statement was directed to the elements as discussed in the previous action. Applicants “asserts that Sacha also does not teach or suggest” the “ear-moldable in-ear wearable apparatus” (Examiner notes again there is no support for this in Applicants spec see 112a) and “at least one of the first of plurality of physiological sensors is integrated into the housing”. Examiner notes that Sacha was not recited for these elements, so the argument is not persuasive and/or moot.
Applicants also argue Sacha does not teach “including a flexible printed circuit board mounted to the ear-mold, the in-ear sensor includes the pulse oximeter sensor integrated with the flexible printed circuit board, the flexible printed circuit board mounted to an ear-mold, the in-ear sensor includes an electrocardiogram sensor connector integrated with the flexible printed circuit board and the in-ear sensor includes a motion sensor integrated with the flexible printed circuit board as independently recited in dependent claims 11-13 and 14.” But Examiner disagrees see the rejection. Examiner notes this is merely a conclusory statement and is not persuasive.
Applicants next argue that Sacha does not resolve the issues they claim are deficient in Tuck and Haan; Examiner believes this is a reference to the “ear-moldable in-ear wearable apparatus” and “at least one of the first of plurality of physiological sensors is integrated into the housing”. Examiner notes that Sacha was not recited for these elements, so the argument is not persuasive and/or moot. Examiner notes that Sacha teaches a health monitoring device, more specifically an ear wearable sensing device, thus it is analogous to the claimed invention and is similar to those of the other prior art references and the invention. Applicants appear to be arguing that the device in the ear canal and detached from the other elements, however this is not persuasive. The Sacha reference recites the form factor/style of the ear device can vary ([0025], [0081]-[0082], [0097]-[0098]; including BTE devices, ITE devices and combination devices). The reference is relied on, in the alternative, for an ITE portion/earbud having a flexible PCB (FPCB) in the ear canal which is disclosed (for example 119c fig. 1C, [0082]). To the extent Applicants appear to be arguing that reference can’t be applied for FPCB because part of the spec describes “configured to remain mechanically decoupled” is not persuasive because the reference is only recited for being used to show it’s known to use a FPCB in an ear earpiece which it does.
In “to be sure . . .”, Applicants recite Sacha doesn’t disclose “is separate from the housing structure. At least one of the first of the plurality of physiological sensors is integrated into the housing, which is separate from the ear-mold.” which Sacha is not relied on to show and thus this isn’t persuasive. Applicants again state Sacha doesn’t disclose the FPCB in the ear mold, see the previous paragraphs, and again this is not persuasive. Applicants further reiterate Sacha is a “deficient reference” and provides a “completely different structure and function”, but Sacha is an ear wearable monitoring device discussing ITE and BTE portions. For the above reasons Applicants arguments are not persuasive.
In “technically . . .” Applicants seem to state the Sacha reference can’t be combined with the Tuck and Haan references. Applicants seem to be arguing they have different purposes, but all the references are related to monitoring using sensors mounted on ear wearable devices, so this is not persuasive. To the extent it’s an analogous argument: as the device is monitoring the user using an ear wearable device it is both in same endeavor of physiological monitoring using an ear wearable device; and the problem with which the inventor was concerned with using an ear wearable device to monitor a user. Examiner notes that Applicants mention Haan and state it “non-physiological monitoring”, Examiner disagrees, see the discussion above regarding Haan and its disclosure of physiological sensing. Applicants seemingly next argue that is not reasonable because a PHOSITA because of the “different functional objectives”. However, Examiner as discussed above disagrees, as each of the devices is directed to an ear wearable monitoring device. Further Applicant is not applying the proper analysis. The final paragraph is a conclusory statement which relies on the more in-depth discussion addressed above. For the above reasons Applicants arguments are not persuasive.
(D)
Applicants state they agree with the Examiner that the Chou and Cordero references do not disclose elements. Examiner notes this statement was directed to the elements as discussed in the previous action. Applicants “asserts that Chou and Cordero also do not teach or suggest” the “ear-moldable in-ear wearable apparatus” (Examiner notes again there is no support for this in Applicants spec see 112a) and “at least one of the first of plurality of physiological sensors is integrated into the housing”. Examiner notes that Chou and Cordero were not recited for these elements, so the argument is not persuasive and/or moot.
Applicants also argue Chou and Cordero do not teach “including a connector mounted on the housing and wearable behind the outer ear of the person, the connector configured for connecting at least one snap electrode to the person spaced apart from the in-ear wearable apparatus for monitoring physiological parameters of the person as independently recited in dependent claim 21.”, but Examiner disagrees see the rejection. Examiner notes this is merely a conclusory statement and is not persuasive.
Applicants next argue (restating it multiple times) that Chou and Cordero do not resolve the issues they claim are deficient in Tuck and Haan; Examiner believes this is a reference to the “ear-moldable in-ear wearable apparatus” and “at least one of the first of plurality of physiological sensors is integrated into the housing”. Examiner notes that Chou and Cordero were not recited for these elements, so the argument is not persuasive and/or moot. Examiner notes that Chou discloses a monitoring device, more specifically an ear wearable sensing device, thus it is analogous to the claimed invention and is similar to those of the other prior art references and the invention. The discussions for both of Chou and Cordero state “importantly” but what they are discussing is not seemingly related to what the references were applied for, which was to show a “connector" on the housing attached to a spaced apart electrode(s) of the wearable for Chou and electrodes are known snap electrode(s) from Cordero. For Chou, they recite the electrode is positioned at a mastoid, but the Chou reference is not limited to just the mastoid and also recites/shows other locations for electrode placement for an EEG reading. Applicants also recite the electrode in Cordero is positioned at a mastoid, but mastoid isn’t even mentioned in the Cordero reference, so that’s not persuasive. To the extent this relies on an intended use argument please see the discussion above about intended uses. To the extent it’s an analogous argument the references are analogous to inventors’ field of endeavor and/or the problem to be solved as laid out by the claim. As Applicants appear to be arguing that it doesn’t teach elements for which they are not applied this is not persuasive. For the above reasons these arguments are not persuasive.
In “technically . . .” Applicants seem to state the Chou and Cordero references can’t be combined with the Tuck and Haan references. Applicants seem to be arguing they have different purposes but Tuck, Haan and Chou references are related to monitoring using sensors mounted on ear wearable devices, so this is not persuasive; while the Cordero reference is merely included to show a particular type of electrode claimed is known. Examiner notes that Applicants mention Haan and state it “non-physiological monitoring”, Examiner disagrees, see the discussion above regarding Haan and its disclosure of physiological sensing. Applicants seemingly next argue that is not reasonable because a PHOSITA because of the “different functional objectives”. However, Examiner disagrees, as each of the devices is directed to an ear wearable monitoring device. Further Applicant is not applying the proper analysis. The final paragraph is a conclusory statement which relies on the more in-depth discussion addressed above. For the above reasons Applicants arguments are not persuasive.
(E)
Applicants state they agree with the Examiner that the Au reference does not disclose elements. Examiner notes this statement was directed to the elements as discussed in the previous action. Applicants “asserts that Chou and Cordero also do not teach or suggest” the “ear-moldable in-ear wearable apparatus” (Examiner notes again there is no support for this in Applicants spec see 112a) and “at least one of the first of plurality of physiological sensors is integrated into the housing”. Examiner notes that Au was not recited for these elements, so the argument is not persuasive and/or moot. Additionally, Examiner notes that the Au reference does disclose a “ear-moldable in-ear wearable apparatus” for the ITE portion see [0036]-[0037] including “Suitable materials for the earpiece 214 include elastomeric material having compliance properties (and dimensions) configured to conform to the shape of the intended portion of the ear canal and exert a spring force on the ear canal so as to hold the receiver assembly 202 in place in the ear canal and press the sensor 216 against tissue within the ear canal for biometric sensing.”.
Applicants also argue Au does not teach “including the in-ear sensor is configured to face a sidewall of the ear canal of the person as independently recited in dependent” claims 23-24, but Examiner disagrees see the rejection. Examiner notes this is merely a conclusory statement and is not persuasive.
Applicants next argue that Au does not resolve the issues they claim are deficient in Tuck and Haan; Examiner believes this is a reference to the “ear-moldable in-ear wearable apparatus” and “at least one of the first of plurality of physiological sensors is integrated into the housing”. Examiner notes that Au was not recited for these elements, so the argument is not persuasive and/or moot, and again Au does disclose a “ear-moldable in-ear wearable apparatus”. Examiner notes that Au discloses a monitoring device, more specifically an ear wearable sensing device, thus it is analogous to the claimed invention and is similar to those of the other prior art references and the invention. Examiner notes that Applicants under the “importantly” section even seem to admit that the reference discloses the structure for which it is applied to in ear sensor on ear mold configured to contact the sidewall of the ear canal. For the above reasons these arguments are not persuasive.
In “to be sure . . .”, Applicants recite Au doesn’t disclose “or teach an ear-mold, that is a moldable ear mold, let alone, physiological sensors in a housing, let alone, the housing with sensors is separate from an ear mold. (See Application, [0054]).” Which Examiner disagrees with. Au does teach based on the above citation a moldable ear mold as well as an earmold separate from the housing but connected by an elongated member, for the above reasons this is not persuasive. The reference is relied on for the sensor on the ear fitting/ITE portion is configured to contact the sidewall which is disclosed. As Applicants appear to be arguing that it doesn’t teach elements for which it is not applied this is not persuasive and again inaccurate because Au does teach the elements Applicants argued it doesn’t teach.
In “technically . . .” Applicants seem to state the Au reference can’t be combined with the Tuck and Haan references. Applicants seem to be arguing they have different purposes, but all the references are related to monitoring using sensors mounted on ear wearable devices, so this is not persuasive. To the extent it’s an analogous argument: as the device is monitoring the user using an ear wearable device it is both in same endeavor of physiological monitoring using an ear wearable device; and the problem with which the inventor was concerned with using an ear wearable device to monitor a user. Examiner notes that Applicants mention Haan and state it “non-physiological monitoring”, Examiner disagrees, see the discussion above regarding Haan and its disclosure of physiological sensing. Applicants seemingly next argue that is not reasonable because a PHOSITA because of the “different functional objectives”. However, Examiner as discussed above disagrees, as each of the devices is directed to an ear wearable monitoring device. Further Applicant is not applying the proper analysis. The final paragraph is a conclusory statement which relies on the more in-depth discussion addressed above. For the above reasons Applicants arguments are not persuasive.
(F)
Applicants state they agree with the Examiner that the Brim reference does not disclose elements. Examiner notes this statement was directed to the elements as discussed in the previous action. Applicants “asserts that Brim also do not teach or suggest” the “ear-moldable in-ear wearable apparatus” (Examiner notes again there is no support for this in Applicants spec see 112a) and “at least one of the first of plurality of physiological sensors is integrated into the housing”. Examiner notes that Brim was not recited for these elements, so the argument is not persuasive and/or moot.
Applicants also argue Brim does not teach “including the housing includes a seal configured to prevent contaminants from entering the housing; and a battery cover removably coupled to the housing for replacing the battery as independently recited in dependent claim 26.” but Examiner disagrees see the rejection. Examiner notes this is merely a conclusory statement and is not persuasive.
Applicants next argue that Brim does not resolve the issues they claim are deficient in Tuck and Haan; Examiner believes this is a reference to the “ear-moldable in-ear wearable apparatus” and “at least one of the first of plurality of physiological sensors is integrated into the housing”. Examiner notes that Brim was not recited for these elements, so the argument is not persuasive and/or moot.
In “to be sure . . .”, Applicants recite Brim doesn’t disclose “or teach an ear-mold, that is a moldable ear mold, let alone, physiological sensors in a housing, let alone, the housing with sensors is separate from an ear mold. (See Application, [0054]).” Which Examiner disagrees with. For example, Brim discloses an ear mold separate from the housing but connected by an elongated member among other elements ([0028], Fig. 1), for the above reasons this is not persuasive. To the extent Applicants appear to be arguing that it doesn’t teach elements for which it is not applied this is not persuasive.
In “technically . . .” Applicants seem to state the Brim reference can’t be combined with the Tuck and Haan references. Applicants seem to be arguing they have different purposes, but the claim which the reference is applied for is directed to the replacement of a battery on an ear wearable device which is what is discussed by the reference, so this is not persuasive. To the extent it’s an analogous argument: as the device discloses a replaceable battery compartment in an ear wearable device it is both in same endeavor of replacing a battery in wearable; and the problem with which the inventor was concerned with how to replace a battery in an ear wearable device. Examiner notes that Applicants mention Haan and state it “non-physiological monitoring”, Examiner disagrees, see the discussion above regarding Haan and its disclosure of physiological sensing. Applicants seemingly next argue that is not reasonable because a PHOSITA because of the “different functional objectives”. However, Examiner disagrees, as Applicant is not applying the proper analysis. The combination does not render Tuck incapable of performing its intended task etc. The final paragraph is a conclusory statement which relies on the more in-depth discussion addressed above. For the above reasons Applicants arguments are not persuasive.
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.
Claim 1-6, 11, 13-21, 23-29 is 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.
Claims 1 and 15 recite “the in-ear wearable apparatus is an ear-moldable in-ear wearable apparatus,” Applicants do not have support in the written description for this level of detail. Applicants’ specification includes an “ear-mold” and in [0055] recites “EWD 100 may further comprise an ear-mold 126 (also referred to herein as an earpiece)” this does not provide sufficient support for the “ear-moldable”. An “ear-mold”/earpiece could simply be an earpiece manufactured (i.e. molded/shaped etc. during injection molding etc.) into a form factor configured to fit in the ear. Applicants based on the amendment in the claim and in view of the arguments are arguing that device is a made of a soft pliable material that “molds” to the ear itself, but there isn’t discussion of this in the specification nor the materials they recite in their arguments etc. Applicants Appear to be attempting to provide support for the amendment in their Remarks/arguments, but remarks are not facts on the record, nor are they part of the originally filed specification. For the above reasons the discussed claim element does not have sufficient written description. The claims depending from these claims share this issue and are likewise rejected.
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 1-6, 11, 13-21, 23-29 is 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.
Claims 1 and 15 recite “wherein the in-ear wearable apparatus is an ear-moldable in-ear wearable apparatus” Applicants recite and “ear moldable in ear wearable apparatus”, however this causes a lack of clarity. To start, while Applicants arguments are not considered facts on the record (see response to arguments above), in arguendo, the arguments presented appear to be arguing it is the portion in the ear which is “ear moldable”. The issue is that it is unclear what the scope of this is, as “in-ear wearable apparatus” is the entire device which is made up of components. Is the “ear moldable” applying to the whole device including the housing, ear mold and the elongated member? or only one of them (such as the ear mold)? Examiner notes the 112a above for “ear moldable”, as such there is no discussion in the specification to understand the term in view of the specification. For the above reasons the claim does not clearly define the metes and bounds of the claim and the claim is indefinite. The claims depending from these claims share this issue and are likewise rejected. For purposes of compact prosecution Examiner is interpreting the “ear moldable” portion to be the “ear-mold”.
Claim 15 recites “a first plurality of physiological sensors”, “a second plurality of physiological sensors” and later recites “via the plurality of physiological sensors”, which causes a clarity issue. It is unclear if “the plurality of physiological sensors” is referring to the first plurality? the second plurality? Or a combination of both? For the above reasons the claim does not clearly define the mete and bounds of the claim and the claim is indefinite. The claims depending from this claim share this issue and are likewise rejected.
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) 1-4, 6, 15-20, 23-24, 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tucker (Steven LeBoeuf, Jesse Tucker et al., US 20140243617) hereinafter Tuck in view of Au (Michael Au et al., US 20220014834) hereinafter Au.
Regarding claim 1, an interpretation of Tuck discloses an in-ear wearable apparatus for monitoring physiological and environmental parameters of a person ([0005], Figs. 9-16), comprising:
a housing wearable on an ear of the person ([0008], [0075] including “The earpiece attachment component 105 is attached to the earpiece module housing 108 and is designed to fit around or near the ear. For example, the standard Bluetooth headset includes an earpiece attachment that is connected to the headset housing via a double-jointed socket, to provide comfort and positioning flexibility for the user. In some embodiments, the earpiece attachment component 105 can be part of the housing 108, such that the entire earpiece module is one largely inflexible, rigid unit.”, [0124] including “A variety of earpiece styles, shapes, and architectures can be used . . . The illustrated earpiece 905 fits over the ear of a person and is held in place by an ear support 901 (also called the “earpiece attachment component” 105).”, [0126], Figs. 9-16);
an ear-mold being coupled to the housing and wearable at least partially within an ear canal of the person ([0021] including “an earpiece module may include an earpiece fitting configured to be inserted . . . within the ear canal of a person wearing the earpiece”, [0124]-[0125], Figs. 9-10, 12 see also [0021], [0126]);
electronics being disposed in the housing and including a controller ([0072], [0103], [0107], Figs. 1, 4) and a transmitter for sending sensor data to a device remotely located from the in-ear wearable apparatus (abstract including “Physiological and environmental data is collected and wirelessly transmitted into a wireless network, where the data is stored and/or processed.”, [0015], [0066], [0072] including “data that can be transmitted wirelessly by the transmitter 104”, [0084]-[0086]);
a battery being disposed in the housing and configured to power the electronics ([0066], [0074] including “The power source can be any portable power source 106 capable of fitting inside the earpiece module housing”, [0075]);
a first plurality of physiological sensors being coupled to the housing and being configured for detecting a plurality of physiological parameters ([0008], [0066]-[0067], [0143], [0145], [0149]-[0150] see also [0075], [0136], [0147]; Examiner notes that this element does not recite the sensors have to be integrated into/on the housing but merely “coupled” to it, this could be sensors located elsewhere but are attached through a an extension element etc. or cable or an elongated member. Examiner notes Tuck does recite a plurality of sensors on the housing/portions not in the ear, such as along the earpiece body and ear support/pinna cover/earpiece attachment component, which are located at a different place on the earpiece module from the sensors located in the ear/ear canal on the earpiece fitting (“ear mold”));
a second plurality of physiological sensors being situated in the ear-mold, wherein the second plurality of the physiological sensors include an in-ear sensor mounted to the ear-mold and wearable within the ear canal of the person ([0021] including “The earpiece fitting may include one or more physiological sensors configured to detect information from within the ear canal.”, [0124]-[0125], [0128] including “For example, the optical module 700 of FIG. 7 may be located in, at, or near the end tip region 1212 in a module 1213. . . . The end tip sensor module 1213 can contain several types of sensors . . . ”, Figs. 9-10, 12 see also [0061], [0136], [0147]), and wherein the in-ear sensor includes at least one of a temperature sensor ([0061], [0128] including “Sensors can also be integrated into the end tip 1212 of the earpiece fitting 1208 to measure physiological properties deeper into the ear canal”, [0147] including “Because the earpiece fitting 1008 is in intimate contact or . . . with the ear canal, body temperature can be very accurately monitored.,”, Figs. 9-10 see also [0067]); and
at least one environmental sensor coupled to the housing and configured to detect at least one environmental condition ([0008], [0012] including “an environmental sensor that is oriented in a direction away from the person”, [0066], [0068], [0153]-[0155]),
wherein the at least one environmental sensor includes a radiation sensor ([0008], [0010], [0068], [0156]) mounted on the housing ([0012], [0075], [0124] including “health and environmental sensors can be integrated within or along the ear support 901,” see also [0008], [0010], [0068], [0156]; reference recites the environmental sensors can be mounted on the housing which includes “ear support” and the ear support runs behind the ear) and wearable behind the outer ear of the person ([0075], [0124] including “ear support 901 (also called the “earpiece attachment component” 105)”; the “earpiece attachment component” or the “ear support” is taught as being included in the housing, having the environmental sensors mounted on it and is disclosed as going behind the ear),
wherein the radiation sensor is disposed on a rear-facing surface of the housing when worn behind the outer ear of the person ([0012] including “an environmental sensor that is oriented in a direction away from the person”, [0075], [0124] including “ear support 901 (also called the “earpiece attachment component” 105)”; the “earpiece attachment component” or the “ear support” is taught as being included in the housing, having the environmental sensors mounted on it and is disclosed as going behind the ear), and
wherein the radiation sensor is configured for ionizing radiation detection ([0008], [0010] including “X-rays, gamma rays . . . atomic energy alpha particles, atomic energy beta-particles”, [0068], [0156]; Examiner notes that alpha, beta, gamma and x-rays are ionizing radiation see applicants Table 3 if required there is additional evidence of this in the conclusion section see the OSHA reference); and
wherein at least one of the first plurality of physiological sensors is integrated into the housing ([0008], [0061], [0075], [0124], [0145], [0147] see also [0066]-[0067]; Recites a plurality of sensors integrated into the housing, such as along the earpiece body and ear support/pinna cover/earpiece attachment component, which are located at a different place on the earpiece module from the sensors located in the ear (or in the ear canal) on the earpiece fitting (“ear mold”)).
The reference teaches the environmental sensor(s) could be a radiation sensor and that environmental sensors can be located behind the ear and facing away from the body. Alternatively, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the environmental radiation sensor on the device behind the ear and disposed on a rear-facing surface of the housing when worn behind the outer ear of the person (i.e. facing away from the body) because Applicant has not disclosed that the placement of the radiation sensor behind the ear facing away from the body provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected placement of the radiation sensor mounted on the housing as recited by Tuck, and applicant' s invention, to perform equally well with either the placement taught by Tuck or the claimed behind the ear facing away from the body because both are placing the environmental sensor (including a radiation sensor) facing out in a similar or the same position as recited by Tuck would perform the same function of radiation sensor equally well.
Therefore, it would have been prima facie obvious to modify Tuck to obtain the invention as specified in claim 1 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Tuck.
An interpretation of Tuck may not explicitly disclose a the housing is wearable behind an outer ear of the person; an elongated member extending between and to the housing and the ear-mold whereby the ear-mold is coupled to the housing, the ear-mold is spaced apart from the housing via the elongated member; wherein the in-ear wearable apparatus is an ear-moldable in-ear wearable apparatus.
However, in the same field of endeavor (medical devices), Au teaches the housing is wearable behind an outer ear of the person ([0027]-[0028] including “The exemplary BTE component 100”, Figs. 1, 3 see also [0002], [0045]; BTE includes a battery among other components); an elongated member extending between and to the housing and the ear-mold whereby the ear-mold is coupled to the housing person ([0027]-[0028] including “A multi-wire cable 206, which may have connectors (not shown) on one or both ends, electrically connects the BTE component 100 to the ITE component 200.”, Figs. 1, 3 see also [0002], [0045]), the ear-mold is spaced apart from the housing via the elongated member person ([0027]-[0028] including “an ITE component 200”, Figs. 1, 3 see also [0002], [0029], [0032], [0045]; discloses an ITE portion connected to a BTE portion through an elongated member wherein the ITE portion also has a plurality sensors located on it); wherein the in-ear wearable apparatus is an ear-moldable in-ear wearable apparatus ([0036]-[0037] including “Suitable materials for the earpiece 214 include elastomeric material having compliance properties (and dimensions) configured to conform to the shape of the intended portion of the ear canal and exert a spring force on the ear canal so as to hold the receiver assembly 202 in place in the ear canal and press the sensor 216 against tissue within the ear canal for biometric sensing.” See also [0045]).
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 smart ear sensing apparatus with a housing behind the ear and an in the ear element with a plurality of sensors (physiological and environmental) within the ear and in the housing outside of the ear as recited by Tuck to include the layout of the housing/BTE portion behind the ear connected by an elongated member to an in an ear mold/ITE portion which conforms to the ear canal as recited by Au providing the advantage of the ear mold/ITE portion conforming to the ear canal to hold the ear mold/ITE portion in place and puts the sensors in contact against the tissue ([0036]).
Regarding claim 2, an interpretation of Tuck further discloses wherein the controller is configured to transmit the plurality of physiological parameters and the at least one environmental condition to a centralized computer ([0073], [0086]-[0088]).
Regarding claim 3, an interpretation of Tuck further discloses wherein the first plurality of physiological sensors further comprises at least one of the following: a GSR sensor ([0008]-[0009], [0061], [0066], [0128]) and an EEG sensor ([0008]-[0009], [0066], [0145]).
Regarding claim 4, an interpretation of Tuck further discloses wherein the at least one environmental sensor comprises at least one of the following: a barometer/humidity sensor ([0008], [0010], [0068], [0157]-[0158] see also [0135]), and a gas sensor ([0008], [0010], [0068]).
Regarding claim 6, an interpretation of Tuck further discloses wherein the at least one environmental sensor comprises the barometer/humidity sensor ([0008], [0010], [0068], [0157]-[0158] see also [0135]), the gas sensor ([0008], [0010], [0068]), and the radiation sensor ([0008], [0010], [0068]).
Regarding Claim 20, an interpretation of Tuck further discloses wherein the first plurality of physiological sensors includes at least one electrode disposed at the housing so as to contact a skin of the person when the in-ear wearable apparatus is worn by the person ([0008]-[0009], [0143], [0145] see also [0061], [0066], [0128]).
Regarding Claim 23, an interpretation of Tuck may not explicitly disclose wherein the in-ear sensor is configured to face a sidewall of the ear canal of the person.
However, in the same field of endeavor (medical diagnostic systems), Au teaches wherein the in-ear sensor is configured to face a sidewall of the ear canal of the person ([0004] including “sensing a biomarker within an ear canal with a biometric sensor that is pressed against the ear canal”, [0028] including “The earpiece 214 positions the sensor apparatus 216 against or adjacent to tissue within the ear canal”, [0029], Fig. 3).
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 smart ear sensing apparatus with a housing behind the ear and an in the ear element with a plurality of sensors (physiological and environmental) within the ear and in the housing outside of the ear as recited by Tuck to include an in ear sensor facing and against a sidewall of an ear canal as recited by Au because it is a good placement for sensing a variety of physiological markers ([0028]).
Regarding Claim 24, an interpretation of Tuck may not explicitly disclose wherein the in-ear sensor is configured to contact the sidewall of the ear canal of the person.
However, in the same field of endeavor (medical diagnostic systems), Au teaches wherein the in-ear sensor is configured to contact the sidewall of the ear canal of the person ([0004], [0028] including “The earpiece 214 positions the sensor apparatus 216 against or adjacent to tissue within the ear canal”, [0029], Fig. 3).
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 smart ear sensing apparatus with a housing behind the ear and an in the ear element with a plurality of sensors (physiological and environmental) within the ear and in the housing outside of the ear as recited by Tuck to include an in ear sensor facing and against a sidewall of an ear canal as recited by Au because it is a good placement for sensing a variety of physiological markers ([0028]).
Regarding Claim 27, an interpretation of Tuck further discloses wherein the at least one electrode of the first plurality of physiological sensors is integrated into the housing ([0008]-[0009] including “one or more physiological sensors . . . supported by (within and/or on) the housing”, [0061], [0143] including “a compact Severinghaus electrode can be incorporated within an earpiece module . . . along or about an ear support.”, [0145] including “electrodes can be either integrated into an earpiece module” see also [0066], [0075], [0124], [0127]-[0128]).
Regarding Claim 28, an interpretation of Tuck further discloses wherein the at least one of the first plurality of physiological sensors is a non-invasive physiological sensor to track electro-activities at a dermal layer occurring internally within a user's body ([0008]-[0009], [0061], [0066], [0127]-[0128]; Tuck recites the earpiece module having a GSR sensor as the sensors are “coupled” to the housing. Examiner notes that based on Applicants discussion “electro-activities at the dermal layer” and of being in dermal contact to measure skin resistance etc. this is another way of reciting galvanic skin response (GSR)).
Regarding Claim 29, an interpretation of Tuck further discloses wherein at least one of the first plurality of physiological sensors is a micro-electro-mechanical systems (MEMS) sensor ([0146], [0159] including “a pedometer or accelerometer . . . can also be integrated into an earpiece module. Pedometers and accelerometers can be integrated into an earpiece module via mechanical sensors (usually implementing a mechanical-electrical switch), MEMS devices, and/or gyroscopic technologies. The technologies required for these types of pedometers and accelerators are well known to those skilled in the art.”).
Regarding claim 15, an interpretation of Tuck discloses a method of monitoring a physiological parameter and an environmental condition of a subject via an in-ear wearable apparatus ([0005], Figs. 9-16), wherein the in-ear wearable apparatus includes a housing wearable on an ear of the person ([0008], [0075] including “The earpiece attachment component 105 is attached to the earpiece module housing 108 and is designed to fit around or near the ear. For example, the standard Bluetooth headset includes an earpiece attachment that is connected to the headset housing via a double-jointed socket, to provide comfort and positioning flexibility for the user. In some embodiments, the earpiece attachment component 105 can be part of the housing 108, such that the entire earpiece module is one largely inflexible, rigid unit.”, [0124] including “A variety of earpiece styles, shapes, and architectures can be used . . . The illustrated earpiece 905 fits over the ear of a person and is held in place by an ear support 901 (also called the “earpiece attachment component” 105).”, [0126], Figs. 9-16), an ear-mold coupled to the housing and wearable at least partially within an ear canal of the subject ([0021] including “an earpiece module may include an earpiece fitting configured to be inserted . . . within the ear canal of a person wearing the earpiece”, [0124]-[0125], Figs. 9-10, 12 see also [0021], [0126]), electronics disposed in the housing and including a processor ([0072], [0103], [0107], Figs. 1, 4) and a transmitter for sending sensor data to a device remotely located from the in-ear wearable apparatus (abstract including “Physiological and environmental data is collected and wirelessly transmitted into a wireless network, where the data is stored and/or processed.”, [0015], [0066], [0072] including “data that can be transmitted wirelessly by the transmitter 104”, [0084]-[0086]), a battery disposed in the housing and configured to power the electronics ([0066], [0074] including “The power source can be any portable power source 106 capable of fitting inside the earpiece module housing”, [0075]),
a first plurality of physiological sensors being coupled to the housing and being configured for detecting a plurality of physiological parameters ([0008], [0066]-[0067], [0143], [0145], [0149]-[0150] see also [0075], [0136], [0147]; Examiner notes that this element does not recite the sensors have to be in the housing but merely “coupled” to it, this could be sensors located elsewhere but are attached through a cable (or an elongated member). Examiner notes Tuck does recite a plurality of sensors on the housing/portions not in the ear, such as along the earpiece body and ear support/pinna cover/earpiece attachment component, which are located at a different place on the earpiece module from the sensors located in the ear/ear canal on the earpiece fitting (“ear mold”)),
a second plurality of physiological sensors, the second plurality of physiological sensors include an in-ear sensor mounted to the ear- mold and wearable within the ear canal of the person ([0021] including “The earpiece fitting may include one or more physiological sensors configured to detect information from within the ear canal.”, [0124]-[0125], Figs. 9-10, 12 see also [0061], [0128], [0147]), the in-ear sensor includes at least one of a temperature sensor ([0061], [0128] including “Sensors can also be integrated into the end tip 1212 of the earpiece fitting 1208 to measure physiological properties deeper into the ear canal”, [0147] including “Because the earpiece fitting 1008 is in intimate contact or . . . with the ear canal, body temperature can be very accurately monitored.,”, Figs. 9-10 see also [0067]), and
at least one environmental sensor ([0008], [0066], [0068], [0153]-[0155]), the at least one environmental sensor includes a radiation sensor ([0008], [0010], [0068], [0156]) mounted on the housing ([0012], [0075], [0124] including “health and environmental sensors can be integrated within or along the ear support 901,” see also [0008], [0010], [0068], [0156]; reference recites the environmental sensors can be mounted on the housing which includes “ear support” and the ear support runs behind the ear) and wearable behind the outer ear of the person ([0075], [0124] including “ear support 901 (also called the “earpiece attachment component” 105)”; the “earpiece attachment component” or the “ear support” is taught as being included in the housing, having the environmental sensors mounted on it and is disclosed as going behind the ear), the radiation sensor is disposed on a rear-facing surface of the housing when worn behind the outer ear of the person ([0012] including “an environmental sensor that is oriented in a direction away from the person”, [0075], [0124] including “ear support 901 (also called the “earpiece attachment component” 105)”; the “earpiece attachment component” or the “ear support” is taught as being included in the housing, having the environmental sensors mounted on it and is disclosed as going behind the ear), the method comprising:
obtaining physiological information from the subject via the plurality of physiological sensors ([0008], [0066]-[0067], [0136], [0145], [0147] see also [0075]), wherein the physiological information comprises at least one of the following: body temperature information ([0061], [0067], [0116], [0147]); and
obtaining environmental information from the subject via the at least one environmental sensor ([0008], [0066], [0068], [0153]-[0155]), wherein the environmental information comprises ionizing radiation information ([0008], [0010] including “X-rays, gamma rays . . . atomic energy alpha particles, atomic energy beta-particles”, [0068], [0156]), and
wherein at least one of the first plurality of physiological sensors is integrated into the housing ([0008], [0061], [0075], [0124], [0145], [0147] see also [0066]-[0067]; Recites a plurality of integrated into the housing, such as along the earpiece body and ear support/pinna cover/earpiece attachment component, which are located at a different place on the earpiece module from the sensors located in the ear (or in the ear canal) on the earpiece fitting (“ear mold”)).
The reference teaches the environmental sensor(s) could be a radiation sensor and that environmental sensors can be located behind the ear and facing away from the body. Alternatively, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the environmental radiation sensor on the device behind the ear and disposed on a rear-facing surface of the housing when worn behind the outer ear of the person (i.e. facing away from the body) because Applicant has not disclosed that the placement of the radiation sensor behind the ear facing away from the body provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected placement of the radiation sensor mounted on the housing as recited by Tuck, and applicant' s invention, to perform equally well with either the placement taught by Tuck or the claimed behind the ear facing away from the body because both are placing the environmental sensor (including a radiation sensor) facing out in a similar or the same position as recited by Tuck would perform the same function of radiation sensor equally well.
Therefore, it would have been prima facie obvious to modify Tuck to obtain the invention as specified in claim 15 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Tuck.
An interpretation of Tuck may not explicitly disclose the housing is wearable behind an outer ear of the person; an elongated member extending between and to the housing and the ear-mold whereby the ear-mold is coupled to the housing, the ear-mold is spaced apart from the housing via the elongated member; wherein the in-ear wearable apparatus is an ear-moldable in-ear wearable apparatus.
However, in the same field of endeavor (medical devices), Au teaches the housing is wearable behind an outer ear of the person ([0027]-[0028] including “BTE component”, Figs. 1, 3 see also [0002], [0045]); an elongated member extending between and to the housing and the ear-mold whereby the ear-mold is coupled to the housing person ([0027]-[0028] including “A multi-wire cable 206, which may have connectors (not shown) on one or both ends, electrically connects the BTE component 100 to the ITE component 200.”, Figs. 1, 3 see also [0002], [0045]), the ear-mold is spaced apart from the housing via the elongated member person ([0027]-[0028] including “an ITE component 200”, Figs. 1, 3 see also [0002], [0029], [0032], [0045]; discloses an ITE portion connected to a BTE portion through an elongated member wherein the ITE portion also has a plurality sensors located on it); wherein the in-ear wearable apparatus is an ear-moldable in-ear wearable apparatus ([0036]-[0037] including “Suitable materials for the earpiece 214 include elastomeric material having compliance properties (and dimensions) configured to conform to the shape of the intended portion of the ear canal and exert a spring force on the ear canal so as to hold the receiver assembly 202 in place in the ear canal and press the sensor 216 against tissue within the ear canal for biometric sensing.” See also [0045]).
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 smart ear sensing apparatus with a housing behind the ear and an in the ear element with a plurality of sensors (physiological and environmental) within the ear and in the housing outside of the ear as recited by Tuck to include the layout of the housing/BTE portion behind the ear connected by an elongated member to an in an ear mold/ITE portion which conforms to the ear canal as recited by Au providing the advantage of the ear mold/ITE portion conforming to the ear canal to hold the ear mold/ITE portion in place and puts the sensors in contact against the tissue ([0036]).
Regarding claim 16, an interpretation of Tuck further discloses transmitting the physiological information and the environmental information to a device remotely located from the subject ([0084]-[0087]).
Regarding claim 17, an interpretation of Tuck further discloses processing the physiological information and the environmental information to determine at least one of the following: a position of the subject and/or a physical distress of the subject ([0146] including “A person's body motion and head position can be monitored by integrating a motion sensor into an earpiece module . . . When the head is moved, a motion sensor detects the displaced motion from the origin. . . the head position monitoring can be used to monitor when someone has fallen down or is not moving.”).
Regarding Claim 18, an interpretation of Tuck further discloses wherein the environmental information further comprises toxic gas information ([0010], [0068], [0155]).
Regarding Claim 19, an interpretation of Tuck further discloses wherein the environmental information further comprises at least one of the following: pressure information ([0008], [0010], [0068], [0157] see also [0135]), humidity information ([0008], [0010], [0068], [0158] see also [0135]).
Claim Rejections - 35 USC § 103
Claim(s) 5, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuck in view of Au in further view of Burwinkel (Justin Burwinkel et al., US 20200268315) hereinafter Bur.
Regarding claim 5, an interpretation of Tuck further discloses wherein the first plurality of physiological sensors comprises the IMU sensor ([0124], [0146], [0148], [0159]; discloses accelerometers and gyroscopes for motion), the pulse oximetry sensor ([0128]-[0129], [0136] including “incorporated into an earpiece module (such as earpiece module 905 of FIG. 9)”, [0140] including “Though the optical techniques of FIG. 17 and FIG. 18 are shown primarily over the earlobe or skin, these techniques can be integrated with the optical physiological signal extraction technique 600, described above with respect to FIG. 6, for measuring blood gas properties at or near the tympanic membrane.”, [0141] including “Thus, the same optical emitter/detector configuration used in earpiece pulse oximetry (FIGS. 17 and 18) can be employed for hydration monitoring. . . These hydration sensors can be mounted anywhere within or along an earpiece. For example, with respect to the earpiece 905 of FIG. 9, hydration sensors can be mounted to a body 902 of the earpiece, the ear support 901, the earpiece backside 906, an earlobe clip, a pinna cover 1402, an earpiece fitting 1208, and the like.”, Figs. 6-7, 9, 12 see also [0009], [0022], [0066], [0117]), the GSR sensor ([0008]-[0009], [0061], [0066], [0128] see also [0124]), the EKG sensor ([0132] see also [0124]), and the EEG sensor ([0008]-[0009], [0066], [0145] see also [0124]).
While Tuck discloses ear device having access to muscle tissue for monitoring muscle tension ([0061]) an interpretation of Tuck may not explicitly disclose EMG sensor.
However, in the same field of endeavor (medical diagnostic devices), Bur teaches EMG sensor ([0058], [0071], [0074], Fig. 8 see also [0046], [0054]-[0055]; ).
For purposes of compact prosecution Examiner notes that Bur also teaches the other sensors in the including an IMU sensor ([0035], [0071]-[0072], [0074], [0077] see also [0046]), GSR ([0033], [0071], [0074]), pulse ox ([0034], [0071], [0074] including “a pulse oximeter” see also [0046]), EKG sensor ([0071], [0074] see also [0033]-[0034]) and EEG ([0033], [0071], [0074]); the sensors can be integrated into the housing of the BTE portion ([0058], [0074], Fig. 8). It also discloses that there are many form factors for ear worn devices ([0055] including “behind-the-ear (BTE), in-the ear (ITE), in-the-canal (ITC), invisible-in-canal (IIC), receiver-in-canal (RIC), receiver in-the-ear (RITE) and completely-in-the-canal (CIC) type hearing assistance devices.”).
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 smart ear sensing apparatus with a plurality of physiological and environmental sensors such as for measuring muscle tension as recited by Tuck in view of Au to include the specific form of measuring muscle tissue of electromyogram (EMG) as recited by Bur because it is merely combining prior art elements according to known methods to yield predictable results. It is also “Obvious to try” an EMG – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success as Bur recites a finite number of identified sensors for use on such a device which in view of the specification would provide predictable solutions with a reasonable chance of success.
Regarding Claim 25, an interpretation of Tuck further discloses an inertial measurement unit (IMU) sensor ([0146], [0148], [0159]; discloses accelerometers and gyroscopes for motion) and configured to measure human motion information ([0067], [0104] including “information from the earpiece sensors 101, 102 can be used to monitor overall “mood” of a user”, [0146], [0148], [0152] including “physical activity . . . can be monitored using . . . an accelerometer . . . and the like.”).
An interpretation of Tuck may not explicitly disclose the IMU as an in-ear sensor in the ear canal.
However, in the same field of endeavor (medical diagnostic devices), Bur teaches the IMU as an in-ear sensor in the ear canal ([0046] including “Each of the hearing assistance devices 102, 602 can include sensor packages as described herein including, for example, an IMU. . . The hearing assistance devices 102, 602 and sensors therein can be disposed within opposing ear canals of the patient.”, [0054], [0055] including “a receiver-in-canal type device and thus the receiver is designed to be placed within the ear canal”, [0072]-[0074] including “Motion sensors herein can include inertial measurement units (IMU)”, Figs. 6-7).
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 smart ear sensing apparatus with a plurality of physiological and environmental sensors including measuring motion using accelerometers and gyroscopes as recited by Tuck in view of Au to include the gathering IMU data from within the ear canal as recited by Bur because it is merely combining prior art elements according to known methods to yield predictable results. It is also “Obvious to try” an IMU – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success as Bur recites a finite number of identified sensors for use on such a device which in view of the specification would provide predictable solutions with a reasonable chance of success.
Claim Rejections - 35 USC § 103
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuck in view of Au or, in the alternative, under 35 U.S.C. 103 as obvious over Tuck in view of Au in further view of Sacha (Michael Sacha et al., US 20240007777) hereinafter Sacha.
Regarding claim 11, an interpretation of Tuck further discloses a flexible printed circuit board mounted to the ear mold ([0129] including “a variety of sensors 1306 can be mounted on the flexible circuit board 1304, and this board can be integrated into any part of the earpiece module . . . Flexible circuitry can be especially useful for odd-shaped components of the earpiece, such as the earpiece fitting 908”, Figs. 9-10, 12-13), and the in-ear sensor comprises the pulse oximeter sensor integrated with the flexible printed circuit board ([0128]-[0129], [0136]-[0139] discusses Figs. 17-18 and pulse ox including transmittance and reflective Pulse Ox, [0140] including “Though the optical techniques of FIG. 17 and FIG. 18 are shown primarily over the earlobe or skin, these techniques can be integrated with the optical physiological signal extraction technique 600, described above with respect to FIG. 6, for measuring blood gas properties at or near the tympanic membrane.”, [0141], Figs. 6-7, 9, 17-18 see also [0112], [0117]; The flexible circuit boards which include the sensors as recited can be used for both the earpiece fitting (i.e. earmold) or earpiece clip with the pulse oximeter - optical emitter/detector being recited as being used on either the fitting or clip).
The examiner interprets the "circuit board" of Tuck to be a PCB, however, in the alternative, Sacha recites a flexible PCB ([0082] including “The PCB 119 c is typically a flexible PCB”, Fig. 1C see also [0081], [0084]) and also recites using such a flexible PCB with pulse ox sensors in the ear ([0076], [0081]-[0082], [0084]).
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 smart ear sensing apparatus with a plurality of physiological and environmental sensors including one or more flexible circuit boards with sensors as recited by Tuck in view of Au to include the flexible circuit board being a flexible printed circuit board as recited by Sacha because it is merely combining prior art elements according to known methods to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuck in view of Au in further view of Sacha.
Regarding claim 13, an interpretation of an interpretation of Tuck further discloses a flexible printed circuit board mounted to the ear mold ([0129] including “a variety of sensors 1306 can be mounted on the flexible circuit board 1304, and this board can be integrated into any part of the earpiece module . . . Flexible circuitry can be especially useful for odd-shaped components of the earpiece, such as the earpiece fitting 908”, Figs. 9-10, 12-13).
An interpretation of Tuck may not explicitly disclose the in-ear sensor comprises an electrocardiogram sensor connector integrated with the flexible printed circuit board.
However, in the same field of endeavor (medical diagnostic devices), Sacha teaches the in-ear sensor comprises an electrocardiogram sensor connector integrated with the flexible printed circuit board ([0075], [0081]-[0082], [0084]-[0086]; Electrodes are connected to Flexible PCB by connectors).
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 smart ear sensing apparatus with a housing behind an outer ear of the person coupled to an ear mold and a plurality of physiological and environmental sensors including one or more flexible circuit boards including a flexible circuit board mounted to the ear mold with sensors as recited by Tuck in view of Au to include the flexible circuit board being a flexible printed circuit board with an ECG sensor connector integrated with the flexible PCB as recited by Sacha because it provides monitoring of the electrical activity of the wearer's heart ([0086]) in a form factor which provides a good fit and comfort within the ear of the wearer ([0082]).
The examiner interprets the "circuit board" of Tuck to be a PCB, however for compact prosecution purposes, in the alternative, Sacha recites a flexible PCB ([0082] including “The PCB 119 c is typically a flexible PCB”, Fig. 1C see also [0081], [0084]) and wherein the flexible printed circuit board further comprises an integrated motion sensor ([0075], [0081]-[0082], [0084]).
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 smart ear sensing apparatus with a plurality of physiological and environmental sensors including one or more flexible circuit boards with sensors as recited by Tuck in view of Au to include the flexible circuit board being a flexible printed circuit board as recited by Sacha because it is merely combining prior art elements according to known methods to yield predictable results.
Regarding claim 14, an interpretation of an interpretation of Tuck further discloses a flexible printed circuit board mounted to the ear mold ([0129] including “a variety of sensors 1306 can be mounted on the flexible circuit board 1304, and this board can be integrated into any part of the earpiece module . . . Flexible circuitry can be especially useful for odd-shaped components of the earpiece, such as the earpiece fitting 908”, Figs. 9-10, 12-13), the in-ear wearable apparatus including a motion sensor ([0129], [0146]).
An interpretation of Tuck may not explicitly disclose the in-ear sensor comprises a motion sensor integrated with the flexible printed circuit board.
However, in the same field of endeavor (medical diagnostic devices), Sacha teaches the in-ear sensor comprises an motion sensor integrated with the flexible printed circuit board ([0075], [0081], [0084], Fig. 1C).
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 smart ear sensing apparatus with a housing behind an outer ear of the person coupled to an ear mold and a plurality of physiological and environmental sensors including one or more flexible circuit boards including a flexible circuit board mounted to the ear mold with sensors as recited by Tuck in view of Au to include the flexible circuit board being a flexible printed circuit board with an ECG sensor connector integrated with the flexible PCB as recited by Sacha because it provides monitoring of the motion of the user determining falls or concussions to assist with their treatment ([0075]) in a form factor which provides a good fit and comfort within the ear of the wearer ([0082]).
The examiner interprets the "circuit board" of Tuck to be a PCB, however for compact prosecution purposes, in the alternative, Sacha recites a flexible PCB ([0082] including “The PCB 119 c is typically a flexible PCB”, Fig. 1C see also [0081], [0084]) and wherein the flexible printed circuit board further comprises an integrated motion sensor ([0075], [0081]-[0082], [0084]).
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 smart ear sensing apparatus with a plurality of physiological and environmental sensors including one or more flexible circuit boards with sensors as recited by Tuck in view of Au to include the flexible circuit board being a flexible printed circuit board as recited by Sacha because it is merely combining prior art elements according to known methods to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuck in view of Au in further view of Chou (Chang-An Chou, US 20110004089) hereinafter Chou in further view of Cordero (Rafael Cordero et al., US 20100022864) hereinafter Cor.
Regarding Claim 21, an interpretation of Tuck may not explicitly disclose a connector mounted on the housing and wearable behind the outer ear of the person, the connector configured for connecting at least one snap electrode to the person spaced apart from the in-ear wearable apparatus for monitoring physiological parameters of the person.
However, in the same field of endeavor (medical diagnostic devices), Chou teaches disclose a connector mounted on the housing and wearable behind the outer ear of the person ([0041]-[0042], Figs. 3A, 4A-C), the connector configured for connecting at least one electrode to the person spaced apart from the in-ear wearable apparatus for monitoring physiological parameters of the person ([0041]-[0042], Figs. 3A, 4A-C; The connector of Chou discloses connecting the ear wearable device to electrodes which are spaced apart from the wearable apparatus at the ear).
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 smart ear sensing apparatus with a housing behind an outer ear of the person coupled to an ear mold and a plurality of physiological and environmental sensors including one or more flexible circuit boards including a flexible circuit board mounted to the ear mold with sensors as recited by Tuck in view of Au to include a connector for connecting to electrodes separated from the wearable device as recited by Chou because it provides a connection for EEG electrode(s) which is shorter decreasing wire pulling and provides higher mobility during EEG measurements ([0010], [0012]).
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the connector mounted on the housing and wearable behind the outer ear because Applicant has not disclosed that the placement of connector mounted on the housing and wearable behind the outer ear provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected placement of the connector mounted on the housing of the behind the ear device as recited by Chou, and applicant' s invention, to perform equally well with either the placement taught by Chou or the claimed behind the ear because both are placing the connector in a similar or the same position as recited by Tuck would perform the same function of providing connection to additional electrodes equally well.
Therefore, it would have been prima facie obvious to modify Tuck to obtain the invention as specified in claim 21 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Tuck.
While Tuck in view of Chou discloses the wearable sensor device with a connector behind the ear for connecting separately located electrodes. An interpretation of Tuck may not explicitly disclose the electrodes are “snap” electrodes.
However, in the same field of endeavor (medical diagnostic devices), Cor teaches the electrodes being snap electrodes ([0036]; Cor recites “common” snap electrodes showing they are generally known or common in the art)
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 smart ear sensing apparatus with a housing including a connector behind an outer ear of the person coupled to an ear mold and a plurality of physiological (including separately located electrodes through the connector) and environmental sensors including one or more flexible circuit boards including a flexible circuit board mounted to the ear mold with sensors as recited by Tuck in view Au in further view of Chou to include the connector is connected to snap electrodes as they are “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success the reference provides a finite number of options ways of connecting electrodes to the device which are identified, predictably and provide a reasonable expectation of successfully connecting the electrodes to the device. 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 discussed above of Tuck in view of Au in further view of Chou with the elements of Cor because it is use of known technique to improve similar devices (methods, or products) in the same way, as recited by Cor the snap electrodes are common and thus a known technique to use with the wires and connector of Tuck in view of Chou.
Claim Rejections - 35 USC § 103
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuck in view of Au in further view of Brimhall (Owen Brimhall et al., US 20110170722) hereinafter Brim.
Regarding Claim 26, an interpretation of Tuck in view of Au discloses the above in claim 1. Including the combination disclosing a BTE housing a battery, see the rejection of claim 1.
An interpretation of Tuck may not explicitly disclose a seal configured to prevent contaminants from entering the housing; and a battery cover removably coupled to the housing for replacing the battery.
However, in the same field of endeavor (medical devices), Brim teaches a seal configured to prevent contaminants from entering the housing ([0034] including “The housing portion 102 may be solid and enclosed so as to prevent the electrical components 132 from being exposed.”, [0037] including “the housing portion 102 may be sealed”, [0059] including “the battery compartment 188 may be protected from moisture by an O-ring”; to the extent the “to prevent contaminants” is an intended use of the device the device recited by the prior art is structurally capable of performing this intended use); and a battery cover removably coupled to the housing for replacing the battery ([0034], [0053], [0058] including “The door 186 may include a second protrusion 130 in order to facilitate the opening and closing of the second portion surface door 186 to access the battery compartment 188.”; Brim recites the door is removably coupled on at least one side in order to open to swap batteries).
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 smart ear sensing apparatus with a housing behind the ear and an in the ear element connected through an elongated member with a plurality of physiological and environmental sensors as recited by Tuck in view Au to include a seal on the device and a battery compartment with a door/cover to change batteries as recited by Brim because it is combining prior art elements (the BTE housing element from Tuck in view of Au with the seal and battery compartment of Brim) according to known methods to yield predictable results a device with seals to protect electronic components and an accessible battery compartment for replacing batteries.
Claim Rejections - 35 USC § 103
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuck in view of Au in further view of Haan (US 20200288253, Haan et al.) hereinafter Haan.
Regarding Claim 30, an interpretation of Tuck further discloses measuring body motion using an MEMs based accelerometer in the earpiece ([0146], [0159] including “a pedometer or accelerometer . . . can also be integrated into an earpiece module. Pedometers and accelerometers can be integrated into an earpiece module via mechanical sensors (usually implementing a mechanical-electrical switch), MEMS devices, and/or gyroscopic technologies. The technologies required for these types of pedometers and accelerators are well known to those skilled in the art.”).
While Tuck discloses integrating a body motion sensor into earpiece an interpretation of Tuck may not explicitly recite wherein at least one of the second plurality of physiological sensors is an accelerometer.
However, in the same field of endeavor (medical devices), Haan teaches wherein at least one of the second plurality of physiological sensors (e.g. on the ear mold in the ear) is an accelerometer ([0061] including “Sensors related to a current mode or state of the user may e.g. be located in the ITE-part.”, [0066] including “a movement detector, e.g. an accelerometer for detecting a linear movement of the hearing device, . . . MEMS acceleration sensors are e.g. available from Bosch Sensortec or Analog Devices.”, Fig. 6 see also [0019], [0024], [0026], [0059], [0122], [0164]).
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 smart ear sensing apparatus with a plurality of physiological and environmental sensors including measuring motion using accelerometers and gyroscopes as recited by Tuck in view of Au to include the gathering accelerometer data from inside the ear canal as recited by Haan because it is merely combining prior art elements (device with known sensor form Tuck with a particular positioning in the device from Haan) 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 20170258329 see figs. 3-8
US 20090177097 to Ma et al.- [0036]-[0037] including “The outer part 38 of the ear bud 50 consists of a soft over-molding made of resiliently deformable memory foam or silicone rubber . . . The foam is compressed when the ear bud 50 is inserted into the ear canal and expands to hold the bud 50 firmly in the ear canal to ameliorate relative motion between the emitters and detectors and the ear canal wall during exercise movement.”, Figs. 3-4, 10
ADInstruments, GSR, https://web.archive.org/web/20190919050316/https://www.adinstruments.com/signal/galvanic-skin-response-gsr, 9/19/19, viewed on 8/28/26
US 20130343584 – Fig. 5-6 – shows different ear pieces styles (see ITE/BTE (or RITE) and earbud styles below). With Fig. 5 showing a plurality of physiological sensors located on both ITE and the BTE portions
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US 20090069645 - [0029], Figs. 5, 7-10 show an ITE with connected BTE element, electronics, and sensors facing the sidewall of an ear canal
US 20200205734 – Figs. 1-3
US 20080165017 – [0004] including “GSR (also known as electrodermal response, skin conductance response, or skin conductance level) is a measure of electrical conductivity of a subject's skin.”, [0061], Figs. 1-2, see Fig. 2 below including a plurality of physiological sensors on the BTE portion. The plurality of physiological sensors on the BTE portion includes electrodes integrated into the BTE housing for GSR sensing
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US 20170078781 – Figs. 1-5b
Occupational Safety and Health Administration (OSHA), Ionizing Radiation, https://web.archive.org/web/20210320083625/https://www.osha.gov/ionizing-radiation/background, per wayback 3/20/21, viewed on 9/12/24
US 5813404 – discloses disposable electrodes which are connected to the leads/wires/cables through a snap, i.e., “snap electrode”
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.
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/James Moss/ Examiner, Art Unit 3792
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