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 .
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 3 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.
In regard to claim 3, the claim recites “the LEDs are arranged at an angle closely aligned with an angle from which the sensor extends from the housing”. First of all, “the LEDs” lacks of sufficient antecedent basis. Secondly, the term “closely” is a relative term which renders the claim indefinite. The term “closely” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what relationship(s) between the two angles are considered as “closely aligned”. Clarification is requested by amendments.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 and 10-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bergmann et al. (USPGPUB 2021/0370088 – applicant cited). 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]).
In regard to claims 2 and 15, Bergmann 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]).
In regard to claim 3, Bergmann discloses the LEDs are arranged at an angle closely aligned with an angle from which the sensor extends from the housing (rejected as best understood, see the 35 USC 112(b) rejection above; Figs. 3 and 11-16 and associated descriptions).
In regard to claims 4 and 16, Bergmann discloses the one or more sources of optical energy provide the light therapy for a predetermined period of time ([0013]; [0079]; [0092]).
In regard to claims 5 and 17, Bergmann discloses the programming code controls the one or more sources of optical energy to provide a continuous wave mode of operation (continuous wave, [0083]).
In regard to claims 6 and 18, Bergmann discloses the programming code controls the one or more sources of optical energy to provide a pulsed wave mode of operation (pulsed configuration, [0083]).
In regard to claims 7 and 19, Bergmann 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]).
In regard to claims 8 and 20, Bergmann discloses the programming code varies the amplitude of the light emitted from the one or more sources of light (pulsed configuration, [0083]).
In regard to claim 10, Bergmann 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]).
In regard to claim 11, Bergmann 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).
In regard to claims 12 and 21, Bergmann 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]).
In regard to claim 13, Bergmann discloses the thermal energy and optical energy are provided simultaneously ([0086]).
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bergmann. In regard to claim 14, Bergmann discloses 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]) but does not specifically disclose the predetermined period of time is approximately one to two hours. 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 one or more sources of the monitor to provide the light therapy for multiple time intervals during a day, including approximately one to two hours per interval, in order to provide sufficient phototherapy to the tissue and/or prevent overheating or damage to the tissue due to long-term operation of the LEDs.
Conclusion
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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