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 .
Applicant’s amendments and remarks filed on 06/29/2026 have been fully considered.
Claims 1-3, 5-8, 10-15, and 17-21 are pending for examination. Claims 4, 9 and 16 are cancelled.
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.
Claims 1-3, 5-8, 10-15, and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Bergmann et al. (USPGPUB 2021/0370088 – applicant cited) in view of Stasko et al. (USPGPUB 2021/0138259). In regard to claims 1 and 14, Bergmann discloses a continuous glucose monitor and a method for delivering optical therapy from a wearable medical device (CGMs, Figs. 3-16 and 25-28 and associated descriptions) comprises a housing (element 60, Figs. 11-16 and associated descriptions); a sensor configured to extend through an opening of the housing and penetrate skin of a user (elements 16 or 32 and associated openings 78, Figs. 3-5 and 11-16 and associated descriptions); one or more sources of optical energy arranged in close proximity to the opening of the housing (elements 20/20-1/20-2, Figs. 3-5 and 11-16 and associated descriptions); and a processor executing programming code to control modulation of the one or more sources of optical energy to provide light therapy to the skin of the user (control module/ microcontroller/ microprocessor, Figs. 25 and associated descriptions; control dosing parameters of the light source, [0015]; [0133]; phototherapy applications, [0085]; increased healing, [0088]) and the one or more sources of optical energy provide the light therapy for a predetermined period of time (0 days to 4 days, [0013] and [0079]) and a microprocessor and/or microcontroller, that actively control and/or determine dosing parameters such as duration, interval, and wavelength provided by the light source ([0133]).
Bergmann does not specifically discloses to provide the light therapy for a predetermined period of time of one to two hours; and unpower the one or more sources of optical energy after the predetermined period of time.
Stasko teaches a phototherapy device and method (Figs. 1-40 and associated descriptions) comprises visible and/or near infrared LEDs ([0034]; [0043]; [0260]) for providing therapeutic light to the skin/ tissue of the user ([0029]) to reduce inflammatory effect (abstract; [0014]) and infection ([0016]), wherein the LEDs provides a dose of light in a specific range of certain J/cm2 or mW/cm2 over a time period of one hour with continuous or pulsed manner ([0050]) and multiple dose can be provided over days ([0016]; [0042]) and inherently the LEDs should be turned off after each dose/ session.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the monitor and method (Bergmann) to incorporate the predetermined therapeutic light dose of one hour and multiple doses per day and associated elements/functions as taught by Stasko, since both devices are phototherapy device for skin/ tissue using visible or near infrared lights, and one of ordinary skill in the art would have recognized that the dose, duration and interval of phototherapy can be set according to the power/ type of LED and tissue properties (see both Bergmann and Stasko). The rationale would have been to provide sufficient therapeutic light dose(s) per day without damaging the tissue.
In regard to claims 2 and 15, Bergmann as modified by Stasko discloses the one or more sources of optical energy comprise: one or more LEDs having a peak wavelength in the visible red light range; and one or more LEDs having a peak wavelength in the near-infrared range (visible light ranges, and infrared (IR) ranges, [0075]; red and near IR, [0078] and [0088]; LEDs, [0082] and [0085] and [0091] of Bergmann; referring to claim 1 above).
In regard to claim 3, Bergmann as modified by Stasko discloses the one or more sources of optical energy are arranged at an angle aligned with an angle from which the sensor extends from the housing (Figs. 3 and 11-16 and associated descriptions of Bergmann).
In regard to claims 5 and 17, Bergmann as modified by Stasko discloses the programming code controls the one or more sources of optical energy to provide a continuous wave mode of operation (continuous wave, [0083] of Bergmann).
In regard to claims 6 and 18, Bergmann as modified by Stasko discloses the programming code controls the one or more sources of optical energy to provide a pulsed wave mode of operation (pulsed configuration, [0083] of Bergmann).
In regard to claims 7 and 19, Bergmann as modified by Stasko discloses the programming code controls the one or more sources of optical energy so as to alternate between the one or more LEDs in the red wavelength range and the one or more LEDs in the near-infrared wavelength range ([0013]; [0079]; [0088]; [0092] of Bergmann).
In regard to claims 8 and 20, Bergmann as modified by Stasko discloses the programming code varies the amplitude of the light emitted from the one or more sources of light (pulsed configuration, [0083] of Bergmann).
In regard to claim 10, Bergmann as modified by Stasko discloses the predetermined period of time begins when the sensor is extended from the housing of the device and into the skin of the user ([0092] of Bergmann).
In regard to claim 11, Bergmann as modified by Stasko discloses the predetermined period of time begins prior to the time when the sensor is extended from the housing of the device and into the skin of the user (a microprocessor and/or microcontroller, that actively control and/or determine dosing parameters such as duration, interval, and wavelength provided by the light source, [0133]; the light sources can be activated before the insertion of the sensor of Bergmann).
In regard to claims 12 and 21, Bergmann as modified by Stasko discloses a resistive element under control of the programming code and co-located with the sensor to provide thermal energy around the sensor (resistance heating, [0086] of Bergmann).
In regard to claim 13, Bergmann as modified by Stasko discloses the thermal energy and optical energy are provided simultaneously ([0086] of Bergmann).
Response to Arguments
Applicant’s arguments, see page 6 of Remarks, filed on 06/29/2026, with respect to claim 3 have been fully considered and are persuasive. The 35 USC 112(b) rejection of claim 3 has been withdrawn.
Applicant’s amendment and argument with respect to claims 1 and 14 filed on 06/29/2026 3/29/2005 have been fully considered but they are deemed to be moot in views of the new grounds of rejection. It is noted that the examiner made a typographical error in the 35 USC 103 rejection section of the previous action, i.e. claim 14 instead of claim 9, however the content of the rejection specifically indicated the limitations of claim 9. In addition, the PTO-326 and the index of claims of the previous action also indicated that claim 9 is rejected. Furthermore, the amendments contain additional limitations than the original claim 9.
Conclusion
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 CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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