DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to the claim objections have been considered. The claim objections are withdrawn. However, additional objections are added.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections under 35 U.S.C. 112(b) are withdrawn.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 of claims 1-4 and 6-7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 1 is objected to because of the following informalities:
“ the temperature sensor disposed” in claim 1 line 8 should recite “the temperature sensor is disposed”.
“an a first end” in claim 1 line 8 should recite “at a first end”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20080181441 A1) in view of Fraden (US 20040254497 A1), further in view of Klemenz (DE-102008024515-B3 English Translation), and further in view of Connor (US 20150313496 A1).
Regarding claim 1, Smith discloses a device (“earpiece assembly”, Abstract) comprising: a fixing frame (earpiece 11, figs. 1 & 6) formed with a frame structure (arcuate rib 13, figs. 1 & 6) and having an inserting portion (opening 61, fig. 6, para. [0053]) and configured to be fixed to an earflap of a user (“held in place within the conchae”, para. [0052]); and a measuring bar (ear insert 12, fig. 1) configured to be inserted into the inserting portion of the fixing frame (para. [0045, 0053]) and comprising an extender (stem 15, figs. 1-2), and a fixing part (head 23, fig. 2), a first end of the extender (“distal end”, para. [0061], fig. 2), wherein the extender is configured to be bent according to a structure of an ear canal of the user to be inserted therein (“stem 15 can bend … conform … ear canal”, para. [0061]), wherein the inserting portion through which the measuring bar is inserted only by linear motion (para. [0045, para. [0045], figs. 3-5) is formed so as to completely pass through a central portion of the fixing frame (“friction … maintain desired length adjustment”; “opening 61 … centered … comfortable”, para. [0083-0084]), and, wherein the fixing part (head 23, fig. 2) is connected to a second end of the extender (“proximal end”, para. [0066], fig. 2) and makes contact with an outer surface of the fixing frame (“head … position on the outward side of earpiece 11”, para. [0066]) to block additional insertion of the extender when the extender is inserted over a predetermined distance (“inhibit undesirable movement”; “position … millimeters of the eardrum … length of 5/8 inch”; “stop”, para. [0015, 0044, 0055, 0058, 0065-0066], fig. 2).
Smith does not disclose a core body temperature measurement device, that the measuring bar is configured to be detachably inserted into the inserting portion of the fixing frame and comprising a temperature sensor, wherein the temperature sensor disposed at an a first end of the extender and configured to measure a core body temperature of the user; wherein the fixing frame comprises: a connector formed at the inserting portion by a first predetermined distance along an inserting direction of the measuring bar, wherein the connector induces an electrical connection between the controller and the temperature sensor, regardless of an inserted length of the extending part extender.
However, Fraden discloses a core body temperature measurement device (Abstract, fig. 2), a fixing frame (reusable cup 39, fig. 10) having an inserting portion (lock 43, fig. 10); a measuring bar (plug 4 having base 11 and tip 12, fig. 2) configured to be detachably inserted into the inserting portion of the fixing frame (fig. 10, “detachable”, para. [0040]) and comprising an extender (tip 12, fig. 2, para. [0027]) a temperature sensor (temperature transducer 5, fig. 2), wherein the temperature sensor disposed at a first end of the extender (“5 … distal end of plug”, para. [0027], as seen in fig. 2) and configured to measure a core body temperature of the user (“internal core temperature”, para. [0001, 0026-0027]); wherein the fixing frame (external supporting disk 7/reusable cup 39, figs. 3 & 10, para. [0040]) comprises: a connector formed at the insertion portion (wires 9; lock 43 (fig. 10 shows the disposable insert 41 inserted into the lock 43); contacts 28, 29, para. [0028, 0040], figs. 1 & 10) wherein the connector induces an electrical connection between an electronic module 8 and the temperature sensor, regardless of an inserted length of the extending part extender (“wires 9 should sink out as little heat as possible, thus they need to be fabricated as thin as practical and should have an extended length inside or on the surface of plug 4. To increase the length, wires 9 may be formed into loop 13 that is positioned between transducer 5 and electronic module 8, regardless of position of the module; transducer 5 attached via wires 9 to first contacts 28; before operation, insert 41 is moved indirection 42 to mate with cup 39. Both cup 39 and insert 41 are engaged and retained together during the temperature monitoring with the help of lock 43. Contacts 28 and 29 provide connection between wires 9 and electronic module 8), para. [0028, 0040]). Fraden further discloses that after monitoring is completed the disposable insert 41 may be detached from cup 39 and discarded (para. [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith such that the earpiece comprises a core body temperature measurement device and the measuring bar is configured to be detachably inserted into the inserting portion of the fixing frame and comprising a temperature sensor, wherein the temperature sensor disposed at an a first end of the extender and configured to measure a core body temperature of the user, and the fixing frame comprises: a connector formed at the inserting portion, wherein the connector induces an electrical connection between an electronics module and the temperature sensor, regardless of an inserted length of the extending part extender, in view of the teachings of Fraden, for the obvious advantage of monitoring the internal core temperature of a person undergoing continuous medical observation by providing the electrical connection regardless of the position of the module and providing a disposable insert that can be detached and discarded after use.
Smith, as modified by Fraden hereinabove, does not disclose that the connector is formed at the inserting portion by a first predetermined distance along an inserting direction of the measuring bar.
However, Klemenz discloses wherein the fixing frame (transformer 35, para. [0036]) comprises a connector (charging contacts 37 are arranged on the plug element 36, para. [0036]) formed at the inserting portion (plug 36, para. [0036]) by a first predetermined distance along an inserting direction of the measuring bar (para. [0036-0037; 0043], plug element 36 and vent 33 are in mutual engagement, the contacts 34 of the hearing aid 11 are electrically contacted by the charging contacts 37 so that a charging current can be transmitted from the charging device; In a further variant, a supply voltage for the signal processing electronics can also be transmitted via the contacts 34, or programming data; plug-in elements 47 are arranged in the same way as the opening 43, 44 of the hearing aid, i.e. they have the same distance from each other).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith, as modified by Fraden hereinabove, such that a connector is formed at the inserting portion by a first predetermined distance along an inserting direction of the measurement bar, in view of the teachings of Klemenz, in order to provide a supply voltage or programming data for the signal processing electronics through a mutual engagement of a mechanical and electrical connection.
Smith, as modified by Fraden and Klemenz hereinabove, does not disclose wherein the fixing frame comprises a controller located above the inserting portion of the fixing frame.
However, Connor directed to a mobile wearable electromagnetic brain activity monitor comprising a frame and comprising one or more sensors selected from thermometer or other temperature sensor (para. [0318]) discloses wherein the fixing frame (head-worn sensor-positioning member 6701, para. [0524], fig. 67) comprises: a controller (control unit 6703, fig. 67) located above (unlabeled, but as seen in fig. 67) the inserting portion (“sensors 6702 … fits into the wearer's ear canal”, para. [0523-0527]) of the fixing frame (as seen in fig. 67). Connor further discloses that the control unit performs data processing to analyze the data and that the brain activity sensors on sensor-positioning member collect data on brain activity concerning object temperature (para. [0342, 0353, 0448]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith, as modified by Fraden and Klemenz hereinabove, such that the fixing frame comprises a controller located above the inserting portion of the fixing frame, in view of the teachings of Connor, for the obvious advantage of providing a mobile earbud monitor having a sensor positioning member that snuggly loops around a portion of the lateral perimeter of the wearer's ear and also fits into the wearer's ear canal and having an incorporated control unit for processing and analyzing sensor data to monitor temperature.
Regarding claim 2, Smith, as modified by Fraden, Klemenz, and Connor hereinabove, discloses the device of claim 1. Smith, as modified by Fraden, Klemenz, and Connor hereinabove, does not disclose wherein the fixing frame further comprises a power source located on the fixing frame and configured to supply a power to the controller.
However, Fraden discloses wherein the fixing frame further comprises: a power source (power source 25, fig. 9) located on the fixing frame (as seen in fig. 9, disk 7 carries power source 25, para. [0039]) and configured to (Examiner’s Note: functional language, i.e., capable of) supply a power to the controller (“power supply”, para. [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith, as modified by Fraden, Klemenz, and Connor hereinabove, such that the fixing frame further comprises a power source located on the fixing frame and configured to supply a power to the controller, in view of the teachings of Fraden, for the obvious advantage of supplying power to the device.
Regarding claim 3, upon the modification of Smith to provide the electrical connection regardless of the position of the module as described with respect to claim 1 above, Smith, as modified by Fraden, Klemenz, and Connor hereinabove, discloses the device of claim 2, wherein the measuring bar (12, fig. 1) is inserted into the inserting portion (61, figs. 1 & 6) formed at the fixing frame (fig. 1, para. [0045, 0053]), and the temperature sensor is electrically connected to the controller as the measuring bar is inserted (Fraden, para. [0028, 0040]).
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Fraden, Klemenz, and Connor, as applied to claim 3 above, and further in view of Bennett (US 20130343585 A1).
Regarding claim 4, Smith, as modified by Fraden, Klemenz, and Connor hereinabove, discloses the device of claim 3. Smith, as modified by Fraden, Klemenz, and Connor hereinabove, does not disclose wherein the measuring bar further comprises: a distance sensor disposed adjacent to the temperature sensor and is configured to measure a distance toward a drumhead of the user, wherein an amount of inserting of the extender is determined based on the measurement of the distance sensor.
However, Bennett directed to a hearing assist device 500 having a first portion 504 and a second portion 506 that extends perpendicularly discloses wherein the measurement bar (506, fig. 5) further comprises a distance sensor disposed adjacent to the temperature sensor (fig. 5, para. [0047, 0050, 0059], IR or sonic distance sensor 514, and inner ear temperature sensor 516 are located on a circular surface of second portion 506 of hearing assist device 500 that faces into the ear of the user) and is configured to measure a distance toward a drumhead of the user, wherein an amount of inserting of the extender is determined based on the measurement of the distance sensor (fig. 5, para. [0047, 0050, 0059], “displacement distance within the ear of user”; “determine a distance to the user's ear drum from hearing assist device 500”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith, as modified by Fraden, Klemenz, and Connor hereinabove, such that the measurement bar further comprises a distance sensor disposed adjacent to the temperature sensor and is configured to measure a distance toward a drumhead of the user, wherein an amount of inserting of the extender is determined based on the measurement of the distance sensor, in view of the teachings of Bennett, in order to prevent over insertion by determining/monitoring a distance to the user's ear drum.
Regarding claim 6, Smith, as modified by Fraden, Klemenz, Connor, and Bennett hereinabove, discloses the device of claim 4, wherein the fixing frame (earpiece 11, fig. 1) further comprises: a coupler located between the extender and the fixing frame (“detents … earpiece”, para. [0043-0044]) and configured to adjust a position of the extender to the fixing frame (“adjustably attached … vary the distance”, para. [0043-0045, 0053-0054]), after the amount of the inserting of the extender is determined (“desired length adjustment … four millimeters from the eardrum”, para. [0043-0045, 0053-0055]]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Fraden, Klemenz, and Connor, as applied to claim 1 above, further in view of Pompei (US 5469855 A), and further in view of Gilad-Gilor (US 20180000336 A1).
Regarding claim 7, Smith, as modified by Fraden, Klemenz, and Connor hereinabove, discloses the device of claim 1. Smith, as modified by Fraden, Klemenz, and Connor hereinabove, does not disclose a fixing cap fixed at a front side of the fixing frame, wherein the extender passes through the fixing cap, and a radius of the fixing cap is configured to be larger than a size of the ear canal of the user to limit insertion of the extender.
However, Pompei directed to remote sensor assembly mounted in a subject's ear canal discloses a fixing cap fixed (insulation 227, fig. 1B) at a front side of a fixing frame (adapter 224, as seen in fig. 1B), wherein the extender (flexible extension 20, fig. 1B) passes through the fixing cap (as seen in fig. 1B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Smith, as modified by Fraden, Klemenz, and Connor hereinabove, such that the device further comprises a fixing cap fixed at a front side of the fixing frame, wherein the extender passes through the fixing cap, in view of the teachings of Pompei for the obvious advantage of ensuring that thermal energy is retained within the ear canal.
Smith, as modified by Fraden, Klemenz, Connor, and Pompei hereinabove, does not disclose that a radius of the fixing cap is configured to be larger than a size of the ear canal of the user to limit insertion of the extender.
However, Gilad-Gilor discloses that a radius of the fixing cap (stopper 820, fig. 2C) is configured to be larger than a size of the ear canal of the user to limit insertion of the extender (para. [0058], stopper 820 is operable to limit the penetration depth of speculum 810 into the ear canal. Stopper 820 is wider than the ear canal … limits the penetration depth mechanically).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith, as modified by Fraden, Klemenz, Connor, and Pompei hereinabove, such that a radius of the fixing cap is larger than a size of the ear canal of the user to limit insertion of the extender, in view of the teachings of Gilad-Gilor, for the obvious advantage of limiting the penetration depth into the ear canal.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Smith (US 20080247561 A1) directed to a variable fit ear insert having an earpiece 11 having an aperture 61, a removably attached insert 12 having head 23, and insert 12 is friction fit within the aperture 61, the earpiece 11 functioning as a top to prevent insert 12 from being inserted too far into the ear (para. [0051-0055]); Wada (US 20100239114 A1) directed to an ear canal fitting unit and a biological signal measuring device.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/A.E.H./Examiner, Art Unit 3791