DETAILED ACTION
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 Amendment
The action is in response to amendments filed on 4/10/2026. Claims 1 and 17 have been amended. Claims 20 have been cancelled. Claims 1-19 are pending and examined below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 2, the claim recites the limitation “wherein the housing comprises: a microphone configured to detect an audio signal presented to the user; and an output transducer configured to output the audio signal detected by the microphone to the user”. However, claim 1, which claims 2 depends on already teaches the limitations. As such claim 2 is not further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-13, 15-16 is/are rejected under 35 U.S.C. 103 as being obvious by US 20170014056 A1 (hereinafter referred to as “Newberry”) in view of US 20200085326 A1 (hereinafter referred to as “Fransen”) and US 5028787 A (hereinafter referred to as “Rosenthal”).
Regarding claim 1, Newberry, a system and method for glucose monitoring, teaches a hearing system (abstract) comprising:
a housing configured to be worn at an ear of a user (as shown in Figures 1, 3-4, 23), the housing comprising:
at least one light source configured to emit a first light and a second light toward tissue at the ear, the first light having a first excitation frequency and the second light having a second excitation frequency different from the first excitation frequency (128; For example, one or more light sources 128 emit a combination of two or more of UV light, visible light and IR light; paragraph [0049]; Figure 1; 2322 and 2314; paragraphs [0158]-[0161]; Figure 23); and
at least one detector configured to detect intensities of the first light at frequencies offset from the first excitation frequency after the first light has been scattered by the tissue and intensities of the second light at frequencies offset from the second excitation frequency after the second light has been scattered by the tissue (104, 106; paragraph [0045], [0049]; Figure 1; 2330 and 2332; paragraphs [0158]-[0161]; Figure 23); and
a processing unit configured to determine, based on the intensities of the first light and the second light, a glucose value representative of a glucose concentration within the tissue (120; paragraphs [0045], [0057]; Figure 1; 2302; paragraph [0153], [0159]; Figure 23).
Newberry does not explicitly teach a microphone configured to detect an audio signal presented to the user; an output transducer configured to output the audio signal detected by the microphone to the user; and wherein the first light and second light each include near-infrared light.
Fransen, a hearing instrument with detector capabilities, teaches a housing comprises: a microphone configured to detect an audio signal presented to the user (paragraph [0259], [0281]-[0282]); and an output transducer configured to output the audio signal detected by the microphone to the user (paragraph [0079]-[0080], [0281]-[0282]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Newberry, to include a microphone and audio output, as taught by Fransen, because doing so adds additional functionality to the ear sensor of Newberry by providing a hearing aid.
Further, Rosenthal teaches wherein the first light and the second light each include near infrared light (claim 27; column 9, lines 14-49). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Newberry, in view of Fransen, to use infrared light for both light sources, as taught by Fransen, because doing so allows the device to measure glucose and making this modification merely combines prior art elements according to known methods well known in the industry (see MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Regarding claim 2, Newberry, in view of Fransen and Rosenthal, teaches a housing comprises: a microphone configured to detect an audio signal presented to the user (paragraph [0259], [0281]-[0282]; as taught by Fransen); and an output transducer configured to output the audio signal detected by the microphone to the user (paragraph [0079]-[0080], [0281]-[0282]; as taught by Fransen).
Regarding claim 3, Newberry, in view of Fransen and Rosenthal, teaches wherein the at least one detector is configured to detect the intensities of the first light and the second light at a single location relative the at least one light source (as shown in Figure 1; as taught by Newberry).
Regarding claim 4, Newberry, in view of Fransen and Rosenthal, teaches wherein the at least one detector includes:
a first detector configured to detect the intensities of the first light and positioned at a first distance from the at least one light source (as shown Figure 23; as taught by Newberry); and
a second detector configured to detect the intensities of the second light and positioned at a second distance from the at least one light source greater than the first distance (as shown Figure 23; as taught by Newberry).
Regarding claim 5, Newberry, in view of Fransen and Rosenthal, teaches wherein a wavelength of the second light is greater than a wavelength of the first light (claim 27; column 9, lines 14-49; as taught by Rosenthal).
Regarding claim 6, Newberry, in view of Fransen and Rosenthal, teaches wherein the first light penetrates the tissue at a first depth and the second light penetrates the tissue at a second depth greater than the first depth such that the second light penetrates deeper into the tissue than the first light (teaches lights are emitted at different wavelengths (light at different wavelengths will be able to penetrate into the skin of the user differently); column 9, lines 14-49; as taught by Rosenthal).
Regarding claim 7, Newberry, in view of Fransen and Rosenthal, teaches wherein the determining the glucose value includes determining the intensities of the first light that was scattered by the tissue at the first depth and determining the intensities of the second light that was scattered by the tissue at the second depth (uses both visible and IR light to detector glucose concentration (light at different wavelengths will be able to penetrate into the skin of the user differently); column 9, lines 14-49; as taught by Rosenthal).
Regarding claim 8, Newberry, in view of Fransen and Rosenthal, teaches wherein the determining the glucose value includes identifying one or both of the intensities of the first light at one or more predetermined frequencies offset from the first excitation frequency or the intensities of the second light at one or more predetermined frequencies offset from the second excitation frequency (paragraphs [0158]-[0161]; as taught by Newberry).
Regarding claim 9, Newberry, in view of Fransen and Rosenthal, teaches wherein the determining the glucose value includes applying one or more conversion factors to the detected intensities (paragraphs [0161]-[0174]; as taught by Newberry).
Regarding claim 10, Newberry, in view of Fransen and Rosenthal, teaches wherein the determining the glucose value includes:
performing a first measurement of each of the first light and the second light (paragraphs [0158]-[0161]);
performing a second measurement of each of the first light and the second light (paragraphs [0158]-[0161]);
determining, based on the first measurement and the second measurement, a change in a peak intensity of one or both of the first light or the second light (paragraphs [0158]-[0161]); and
correlating the change in the peak intensity to the glucose value (paragraphs [0158]-[0161]).
Regarding claim 11, Newberry, in view of Fransen and Rosenthal, teaches wherein the change in the peak intensity is indicative of a change in the glucose concentration within the tissue between the first measurement and the second measurement (paragraphs [0158]-[0161]; as taught by Newberry).
Regarding claim 12, Newberry, in view of Fransen and Rosenthal, teaches wherein the glucose value increases as the change in the peak intensity increases and wherein the glucose value decreases as the change in the peak intensity decreases (paragraphs [0158]-[0161]; as taught by Newberry).
Regarding claim 13, Newberry, in view of Fransen and Rosenthal, teaches wherein each of the first measurement and the second measurement includes:
determining the intensities of the first light that was scattered by the tissue at a first depth and determining the intensities of the second light that was scattered by the tissue at a second depth (column 9, lines 14-49; as taught by Rosenthal); and
identifying the peak intensity of one or both of the intensities of the first light at one or more predetermined frequencies offset from the first excitation frequency or the intensities of the second light at one or more predetermined frequencies offset from the second excitation frequency (paragraphs [0158]-[0161]; as taught by Newberry).
Regarding claim 15, Newberry, in view of Fransen and Rosenthal, teaches wherein the at least one detector includes a filter configured to filter the first light at the first excitation frequency after the first light has been scattered by the tissue and the second light at the second excitation frequency after the second light has been scattered by the tissue (paragraphs [0134]-[0135]; as taught by Newberry).
Regarding claim 16, Newberry, in view of Fransen and Rosenthal, teaches wherein the processing unit is further configured to provide the glucose value for display by a display device (paragraphs [0083]-[0084]; as taught by Newberry).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newberry, in view of Fransen and Rosenthal, as applied to claim 1 above, and further in view of US 20040162470 A1 (hereinafter referred to as “Tu”).
Regarding claim 14, Newberry, in view of Fransen and Rosenthal, teaches being capable of using two IR lights (For example, one or more light sources 128 emit a combination of two or more of UV light, visible light and IR light; paragraph [0049]; Figure 1); but does not explicitly teach the emitters being monochromatic.
However, Tu, a non invasive blood glucose monitor, teaches the emitter being monochromatic (abstract). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Newberry, in view of Fransen and Rosenthal, to use monochromatic emitters, as taught by Tu because making this modification merely combines prior art elements according to known methods well known in the industry (see MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103as being obvious by Newberry in view of Rosenthal.
Regarding claim 17, Newberry, a system and method for glucose monitoring, teaches a method (abstract) comprising:
causing, by at least one computing device (paragraphs [0153]; Figure 23), at least one light source to emit a first light and a second light toward tissue at an ear of a user, the first light having a first excitation frequency and the second light having a second excitation frequency different from the first excitation frequency (uses both visible and IR light to detector glucose concentration; paragraphs [0158]-[0161]);
causing, by the at least one computing device (paragraphs [0153]; Figure 23), at least one detector to detect intensities of the first light at frequencies offset from the first excitation frequency after the first light has been scattered by the tissue and intensities of the second light at frequencies offset from the second excitation frequency after the second light has been scattered by the tissue (paragraphs [0158]-[0161]); and
determining, by the at least one computing device and based on the intensities of the first light and the second light, a glucose value representative of a glucose concentration within the tissue (120; paragraphs [0045], [0057]; Figure 1; 2302; paragraphs [0153]; Figure 23).
Newberry does not explicitly teach wherein the first light and second light each include near-infrared light.
Further, Rosenthal teaches wherein the first light and the second light each include near infrared light (claim 27; column 9, lines 14-49). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Newberry, in view of Fransen, to use infrared light for both light sources, as taught by Fransen, because doing so allows the device to measure glucose and making this modification merely combines prior art elements according to known methods well known in the industry (see MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Regarding claim 18, Newberry, in view of Rosenthal, teaches wherein the determining the glucose value includes:
performing a first measurement of each of the first light and the second light (paragraphs [0158]-[0161]);
performing a second measurement of each of the first light and the second light (paragraphs [0158]-[0161]);
determining, based on the first measurement and the second measurement, a change in a peak intensity of one or both of the first light or the second light (paragraphs [0158]-[0161]); and
correlating the change in the peak intensity to the glucose value (paragraphs [0158]-[0161]).
Regarding claim 19, Newberry, in view of Rosenthal, teaches wherein each of the first measurement and the second measurement includes determining the intensities of the first light that was scattered by the tissue at a first depth and determining the intensities of the second light that was scattered by the tissue at a second depth greater than the first depth (uses both visible and IR light to detector glucose concentration (light at different wavelengths will be able to penetrate into the skin of the user differently; column 9, lines 14-49; as taught by Rosenthal).
Response to Arguments
Applicant’s arguments, filed 04/10/2026, with respect to 35 USC 112(b) rejections and the 35 USC 101 rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections and the 35 USC 101 rejections have been withdrawn.
Applicant’s arguments, filed 04/10/2026, with respect to the rejection(s) of claim(s) 1 and 17under the prior art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made by Newberry, in view of Fransen and Rosenthal, for claim 1 and Newberry in view of Rosenthal for claim 17.
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.
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/ABID A MUSTANSIR/Examiner, Art Unit 3791