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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/5/26 has been entered.
Response to Amendment
Receipt is acknowledged of applicant's amendment filed on 1/5/26. Claim 22 is new. Claims 1-20 and 22 are currently pending and an action on the merits is as follows.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a glucose sensor portion” in claim 8 which is assumed to be a near infrared light or laser based on pg. 5 of the specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-13, 20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Connor (U.S. Pub. No. 2017/0164878) and Inakoshi (U.S. Pub. No. 2017/0041711) and Hisano et al. (U.S. Pub. No. 2002/0091049).
Regarding claim 1 and 8, Connor discloses:
An earpiece ([¶357,741][Figure. 69]) comprising: an earpiece housing configured as a unibody ear bud to be positioned within the ear of the user, and sized and shaped to fit a portion of the earpiece housing into an external auditory canal (¶741, Wearable sensor maybe worn on, around or within the ear canal and is a single unit); an intelligent control disposed within the earpiece housing, wherein the intelligent control comprises at least one processor ([¶744] data processor 6905) a glucose sensor associated with the earpiece housing, the glucose sensor operatively connected to the intelligent control ([¶744] the sensors 6902 and 6903) and the glucose sensor comprises a glucose sensor portion which emits detection signals ([¶132,133,407] near infrared light can be used) wherein the glucose sensor is operative to continuously monitor blood glucose when the glucose sensor is positioned within the external auditory canal ([¶24,347,351,357]): wherein the glucose sensor is operatively connected to the at least on processor of the intelligent control, configured to communicate glucose data to the at least one processor of the intelligent control disposed in the earpiece ([¶647,410,741] the signals from the detector are communicated to the microprocessor to determine glucose), wherein the intelligent control is configured to determine a first glucose level associated with a user of the earpiece using the glucose sensor communicated glucose data and the intelligent control is configured to communicated from the earpiece the feedback of at least some of the glucose levels associated with the user ([¶647,410,741] the signals from the detector are communicated to the microprocessor to determine glucose. [¶331,335] a display can show the glucose) and communicating wirelessly the glucose levels of the individual from the earpiece (See FIG4 and Paragraph 36);
Wherein the earpiece comprises ([¶344] discloses wherein the ear worn device can comprise multiple biosensors); the earpiece housing is sized and shaped to fit a portion of the earpiece housing into the external auditory canal ([¶351,357] disclose wherein the earpiece device can be inserted into an ear canal and take measurements from tissue within the ear canal); wherein the earpiece housing is an earbud housing and the glucose sensor configure to position the earbud against the wall of the external auditory canal ([¶347,351] discloses a sensor in an ear bud arrangement that takes readings from the inside of the external auditory canal).
Connor does not disclose
The earpiece housing is configured to position the glucose sensor the superior wall of the auditory canal proximate a superficial temporal, which provides the superior wall of the external auditory canal with a blood supply.
Connor discloses an earbud that sensing from tissues in the ear canal and in the same field of physiological and glucose monitoring ear devices, Inakoshi teaches:
that monitoring the superficial temporal artery that is located on the superior surface and the anterior surface of the canal is useful for monitoring biological information ([¶26,39] the sensors are positioned against the superior wall of the auditory canal).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination to incorporate the teachings of Inakoshi in order to collect biological information while the user listens to the content or uses the phone ([¶39]).
Connor as modified does not specifically disclose that the glucose sensor is isolated from the ambient environment. Connor does disclose the sensor can be on a device inserted in the ear canal which would isolate it somewhat from the ambient environment.
In the same field of glucose monitoring devices, Hisano teaches:
A similar sensing device that comprises an earbud that had a photosensor ([¶56][Figure. 6] emitter 211 and detector 212) and fits snugly into the ear thus blocking out ambient noise ([¶56][Figure. 7] where the expanding portion 213 snugs the sensor to the canal wall).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Connor with the teachings of Hisano in order to get a clearer signal ([¶56]).
Regarding claims 2 and 9, Connor further discloses:
a wireless transceiver disposed within the earpiece housing; the wireless transceiver operatively connected to the intelligent control to wirelessly communicate at least some of the glucose levels associated with the user from the earpiece ([¶196,747] describes wherein the processor is in connection with a transmitter device for wirelessly transmitting the data).
Regarding claims 3 and 10, Connor further discloses:
wherein the glucose sensor is a non-invasive glucose sensor ([¶357,741][Figure. 69]).
Regarding claim 4 and 12, Connor further discloses:
wherein the glucose sensor is a near infrared glucose sensor ([¶199,919] describes wherein the emitter can use near-infrared light).
Regarding claim 5, Connor does not disclose:
wherein the earpiece is a first earpiece within a set of earpieces comprising the first earpiece and a second earpiece.
In the same field of glucose monitoring devices, Inakoshi discloses:
A second earpiece for determining a glucose level associated with the user ([FIG.1,4]). One of the set of earpieces configured as a right earpiece and one of the set of earpieces configured as a left earpiece to fit within the respective right ear and left ear ([FIG1]).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Connor to incorporate a second earpiece for, as taught by Inakoshi, in order to improve the accuracy and reliability of the reading by having a measurement device located at both ears in case of device failure or dislodgement of one of the ear pieces.
Regarding claim 6, Connor does disclose wherein the visual feedback of the glucose levels provides a continuous feedback of glucose levels of the user ([¶336] provides continuous feedback based on the sensed glucose signals).
Connor does not disclose:
wherein the first earpiece wirelessly communicates the glucose levels associated with the user of the first earpiece to the second earpiece.
In the same field of glucose monitoring devices, Inakoshi discloses:
A second earpiece for determining a glucose level associated with the user ([FIG.1,4]) and the first earpiece wirelessly communicates the glucose levels associated with the user of the first earpiece to the second earpiece ([FIG.4]).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Connor to incorporate a second earpiece for determining a glucose level associated with the user, as taught by Inakoshi, in order to improve the accuracy and reliability of the reading by having a measurement device located at both ears in case of device failure or dislodgement of one of the ear pieces.
Regarding claim 7, Connor discloses the earpiece further comprises: a speaker operably coupled to the intelligent control (Paragraph 0351 discloses wherein the wearable device can be encompassed by a set of earpieces and paragraph 0354 discloses wherein the ear-worn component can include a left side and a right side ear-worn component and paragraph 0483 discloses wherein the wearable device can contain a speaker); and a microphone operably coupled to the intelligent control (Paragraph 0329 discloses wherein the wearable device can contain a microphone); wherein the intelligent control disposed within the earpiece housing configured to play music and/or audio (paragraph 0483 discloses wherein the wearable device can contain a speaker for playing voice audio).
Regarding claim 11. Connor discloses the glucose sensor provides continuous measurement ([¶332] describes continuous monitoring).
Regarding claim 13, Connor does not disclose:
wherein the earpiece if a first earpiece within a set of earpieces comprising the first earpiece and the second earpiece and wherein the method further comprises wireless communicating the glucose levels of the individual from the first earpiece to the second earpiece.
In the same field of glucose monitoring devices, Inakoshi discloses:
A second earpiece for determining a glucose level associated with the user ([FIG.1,4]) and the first earpiece wirelessly communicates the glucose levels associated with the user of the first earpiece to the second earpiece ([FIG.4][¶31]).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Connor to incorporate a second earpiece for determining a glucose level associated with the user, as taught by Inakoshi, in order to improve the accuracy and reliability of the reading by having a measurement device located at both ears in case of device failure or dislodgement of one of the ear pieces.
Regarding claim 20, Inakoshi teaches the earpiece housing, further comprising a speaker operably coupled to the intelligent control disposed within the earpiece housing, wherein the speaker communicates to the user the feedback of at least some of the glucose levels determined at the intelligent control disposed in the earpiece ([FIG.1] the sound output units).
Regarding claim 22, Hisano teaches the device further comprising on the earpiece housing a second glucose sensor positioned against an inferior wall of the external auditory canal proximate a stylomastoid artery supplying blood to the inferior wall of the external auditory canal ([FIG.6,7]).
Claims 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Connor, Inakoshi and Hisano in view of Newberry (U.S. Pub. No. 2017/0014056).
Regarding claim 14, Connor discloses:
An earpiece ([¶357,741][Figure. 69]) comprising: an earpiece housing configured as a unibody ear bud to be positioned within the ear of the user, and sized and shaped to fit a portion of the earpiece housing into an external auditory canal (¶741, Wearable sensor maybe worn on, around or within the ear canal and is a single unit); an intelligent control disposed within the earpiece housing, wherein the intelligent control comprises at least one processor ([¶744] data processor 6905) a glucose sensor associated with the earpiece housing, the glucose sensor operatively connected to the intelligent control ([¶744] the sensors 6902 and 6903): wherein the glucose sensor is operatively connected to the at least on processor of the intelligent control, configured to communicate glucose data to the at least one processor of the intelligent control disposed in the earpiece ([¶647,410,741] the signals from the detector are communicated to the microprocessor to determine glucose), wherein the intelligent control is configured to determine a first glucose level associated with a user of the earpiece using the glucose sensor communicated glucose data and the intelligent control is configured to communicated from the earpiece the feedback of at least some of the glucose levels associated with the user ([¶647,410,741] the signals from the detector are communicated to the microprocessor to determine glucose. [¶331,335] a display can show the glucose) and communicating wirelessly the glucose levels of the individual from the earpiece (See FIG4 and Paragraph 36);
Wherein the earpiece comprises ([¶344] discloses wherein the ear worn device can comprise multiple biosensors); the earpiece housing is sized and shaped to fit a portion of the earpiece housing into the external auditory canal ([¶351,357] disclose wherein the earpiece device can be inserted into an ear canal); wherein the earpiece housing is an earbud housing and the glucose sensor configure to position the earbud against the wall of the external auditory canal ([¶347,351] discloses a sensor in an ear bud arrangement that takes readings from the inside of the wall of the external auditory canal) and a second earpiece ([¶344] discloses wherein the ear worn device can comprise multiple biosensors and [¶351] discloses wherein the wearable diagnostic component can be a set of earpieces and [¶354] discloses wherein the ear-worn component can include a left side and a right side ear-worn component and [¶357] discloses wherein the ear worn device can measure glucose levels).
Connor does not disclose
that the earpiece housing is configured to position the glucose sensor against the superior wall of the external auditory canal proximate a superficial temporal artery supplying blood to the superior wall.
In the same field of glucose monitoring devices, Inakoshi discloses:
A second earpiece for determining a glucose level associated with the user ([FIG.4]) and the first earpiece wirelessly communicates the glucose levels associated with the user of the first earpiece to the second earpiece ([FIG.1,4][¶31]) and wherein the processor is within the earbud ([¶30] controller 114 is a processor). Inakoshi also teaches that monitoring the superficial temporal artery that is located on the superior surface and the anterior surface of the canal is useful for monitoring biological signals ([¶39]).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Connor to incorporate a second earpiece for determining a glucose level associated with the user, as taught by Inakoshi, in order to improve the accuracy and reliability of the reading by having a measurement device located at both ears in case of device failure or dislodgement of one of the ear pieces.
Connor as modified does not specifically disclose that the glucose sensor is isolated from the ambient environment. Connor does disclose the sensor can be on a device inserted in the ear canal which would isolate it somewhat from the ambient environment.
In the same field of glucose monitoring devices, Hisano teaches:
A similar sensing device that comprises an earbud that had a photosensor ([¶56][Figure. 6] emitter 211 and detector 212) and fits snugly into the ear thus blocking out ambient noise ([¶56][Figure. 7] where the expanding portion 213 snugs the sensor to the canal wall).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Connor with the teachings of Hisano in order to get a clearer signal ([¶56]).
Yet the combination does not disclose:
Wherein the intelligent control of an earpiece is configured to determine a second glucose level associated with the user of the earpiece using the glucose sensor of the earpiece; wherein the set of earpieces is configured to communicate the first glucose level and the second glucose level and compare the first glucose level from the glucose sensor and the second glucose level from the glucose sensor using at least one intelligent control of the set of wireless earpieces to increase accuracy and/or detect error in sensed the first glucose level and the second sensed glucose level.
However, in the same field of earpiece glucose measurement systems, Newberry discloses:
wherein the intelligent control of an earpiece is configured to determine a second glucose level associated with the user of the earpiece using the glucose sensor of the earpiece (Paragraph 0007 discloses wherein a device located within the ear canal of a patient measures a first and second glucose level measurement); wherein the set of earpieces is configured to communicate the first glucose level and the second glucose level and compare the first glucose level from the glucose sensor and the second glucose level from the glucose sensor using at least one intelligent control of the set of wireless earpieces to increase accuracy and/or detect error in sensed the first glucose level and the second sensed glucose level (paragraphs 0005-0007 and 0050,0151 disclose wherein the earpiece system determines a first glucose level measurement and a second glucose level measurement and compares the two measurements in order to determine accuracy or detect error).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination to incorporate wherein the intelligent control of an earpiece is configured to determine a second glucose level associated with the user of the earpiece using the glucose sensor of the earpiece; wherein the set of earpieces is configured to communicate the first glucose level and the second glucose level and compare the first glucose level from the glucose sensor and the second glucose level from the glucose sensor using at least one intelligent control of the set of wireless earpieces to increase accuracy and/or detect error in sensed the first glucose level and the second sensed glucose level; and wherein the set of wireless earpieces is configured to compare at least one of the first glucose level and the second glucose level to a threshold glucose level, as taught by Newberry, in order to improve the accuracy of the measurement by taking multiple measurements and comparing the separate measurements in order to determine potential error.
Regarding claim 15, Connor discloses
The at least one of the first glucose level and the at least one of the second glucose of the individual from the earpieces is communicated wirelessly to a mobile device from at least one earpiece of the set of earpieces using the wireless transceiver disposed within the ear piece housing of one of the each of the earpieces, the wireless transceiver operatively connected to the intelligent control ([¶196,310] describes wherein the processor is in connection with a radio transceiver device for wirelessly transmitting the data and Inakoshi teaches wherein the ear buds can communicate between each other, therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Connor by incorporating the earpiece as an earpiece set capable of wirelessly communicating data between each other, as taught by Inakoshi, in order to improve the accuracy and reliability of the reading by having a measurement device located at both ears in case of device failure or dislodgement of one of the ear pieces).
Regarding claim 16, Connor discloses the glucose sensor is a non-invasive glucose sensor ([¶131] describes wherein the glucose monitoring sensor is non-invasive).
Regarding claim 17, Connor discloses the glucose sensor provides continuous measurement ([¶332] describes continuous monitoring).
Regarding claim 18, Connor discloses the glucose sensor is a near infrared glucose sensor ([¶199,919] describes wherein the emitter can use near-infrared light).
Regarding claim 19, Connor discloses the intelligent control operatively connect to a gesture control interface wherein a user interacts with the earpiece through gesture ([¶331]).
Response to Arguments
Applicant's arguments filed 4/16/26, have been fully considered but they are not persuasive.
Regarding Applicant’s arguments against the 103 rejection, Examiner respectfully disagrees. Regarding Applicant’s arguments that ¶23 of Connor does not disclose the sensor placed in the external auditory canal. ¶23 was cited in error, however, ¶741 and 744, previously cited and relied on in the previous rejection disclose the sensor placement within the external auditory canal. Additionally, ¶347,351,357, also disclose the sensor is placed in the external auditory canal and the specification as a whole shows this feature.
Regarding Applicant’s argument that Inakoshi does not teach positioning the sensor against the superior wall of the external auditory canal proximate the superficial artery, Examiner respectfully disagrees. Inakoshi teaches an in-ear sensor that uses light sensors like Connor and positions the sensors on the upper portion of the ear canal. The upper portion of the ear canal is the superior surface of the ear canal. The sensor is then inherently proximate the superficial temporal artery as it runs anterior and superior to the ear canal. Proximate is not defined by any specific range and the ear canal is near the superficial temporal artery.
Regarding Applicant’s argument directed to ¶26, Inakoshi teaches that sensor does not need to contact the ear canal but this does not mean that it does not contact the ear canal walls nor does it teach away from contact. Inakoshi clearly teaches that the sensor does not have to be in direct physical contact with the ear canal but since the device is an ear bud type sensor it will contact the ear canal or be very close to the ear canal walls if it is not in direct contact. Similarly, the claim does not require direct physical contact just that the sensor is “against” a wall. Against’ s general meaning being opposite or directly opposed. Applicant argues that Inakoshi does not teach the precise anatomical positioning against the superior wall but the claim does not require precise positioning, just that the sensor housing is configured to position the glucose sensor against a superior wall of the external auditory canal proximate a superficial temporal artery.
Regarding Applicant’s argument that there is no motivation to combine Connor and Inakoshi, Examiner respectfully disagrees. Inakoshi teaches that the device allows for listen to music or phone calls while it is monitoring physiological signals (¶36,39) which Connor does not specifically disclose and provides the advantage of multi-functional use.
Regarding Applicant’s that Hisano does not disclose a second glucose sensor positioned against an inferior wall of the external auditory canal proximate a stylomastoid artery supplying blood to the inferior wall of the auditory canal, Examiner respectfully disagrees. Hisano teaches positioning a similar photosensor device on the lower or inferior wall of the ear canal (FIG.7, ¶52). This is proximate the stylomastoid artery as the he superficial temporal artery, the deep auricular artery, the stylomastoid artery, and the posterior auricular artery all provide blood to the ear canal.
Regarding Applicant’s arguments that Newberry does not teach comparing the glucose measurements taken by two separate earpieces, Examiner respectfully disagrees. Newberry is relied on to teach comparing signals from separate detectors. Inakoshi is relied on to teach using detectors in both ears to provide stereo sound for music and to measure at two separate biological locations. Newberry is then relied on to teach comparing separate glucose measurements from the different detector emitter pairs and if those measurements from different detectors are within a threshold range calculating a final glucose measurement for output ([¶151]). This comparison between detectors enhances accuracy of the final glucose determination. So in the combined device the measurements from different detectors would be across the left and right detectors.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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