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 .
The action is in response to the application filed on 01/20/2023. Claims 1-20 are pending and examined below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Regarding claims 1-19, the claims are rejected under 35 U.S.C. 101 because the claimed invention is directed to receiving and manipulating data without significantly more.
Claim 1 recites “A hearing system comprising: a housing configured to be worn at an ear of a user, 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; 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; 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.”
This falls into a mental process grouping of abstract ideas. These limitations are either capable of being performed mentally by looking at measurements and making mental assessments thereafter or considered insignificant extra-solution activity.
The steps of emitting 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 and detecting 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 is insignificant extra-solution activity (mere data gathering).
The step of determining, based on the intensities of the first light and the second light, a glucose value representative of a glucose concentration within the tissue is a mental process that can be performed in a human mind or by a pencil and paper by a skilled clinician.
Additionally the judicial exception is not integrated into a practical application because the additional element of a processing unit for performing the steps is, at its broadest reasonable interpretation, a generic computer structure for performing the generic computer function of data processing, which does not qualify as an integration of the abstract idea into a practical application. Likewise, the inclusion of a ear worn light emitter and detector (a generic ear worn optical sensor) for measuring data is merely insignificant, extra-solution activity in the form of mere data gathering, which also does not qualify as an integration of the abstract idea into a practical application.
Finally, the claims analyzed as a whole do not provides any element, or combination of elements, sufficient to amount to significantly more than the mental process as only a processing unit and generic optical sensor for data collection are claimed. As noted previously, the addition of a generic computer structure for performing the generic computer function of data processing and the inclusion of a generic ear worn optical sensor for gathering data (merely insignificant, extra-solution activity in the form of mere data gathering), does not qualify as significantly more than the abstract idea itself. Additionally, the claimed sensors are well-understood, routine and conventional activity and thus do not amount to significantly more than the abstract idea itself.
The following examples show that the generic optical sensor is well understood, routine, and conventional activity: US 20170014056 A1; US20200085326A1
Regarding dependent claims 3, 5-16, the claims also fail to add something more to the abstract independent claims as they merely further limit the abstract idea or provide insignificant extra solution activity.
Regarding dependent claims 2 and 4, the claim describes the system in sufficient particularity such as to integrate the abstract idea into a practical application.
Regarding claim 17, the claim recites a parallel method claim to that of claim 1 and is rejected for substantially the same reasons.
Regarding dependent claims 18-19, the claims also fail to add something more to the abstract independent claims as they merely further limit the abstract idea or provide insignificant extra solution activity.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1 and 20, and claims dependent thereof, 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.
Regarding claim 1, the claim recites the limitation “a hearing system” in the preamble. However, the body of the claims fails to recite any elements that are related to the device being a hearing aid, and rather just has the limitations of emitters, detectors, and a processing unit. As such it is unclear as to whether the device is actually a hearing device. As such the claim is indefinite.
For the purposes of this examination it is interpreted as not being a hearing system.
Regarding claim 20, the claim recites the limitations “determining, based on the intensities of the first light and the second light, a glucose value representative of a glucose concentration within the tissue”. However, the claim fails to recite a structural element (ie a processor) capable of determining a glucose concentration. As such the claim is indefinite.
For the purposes of this examination this claim is interpreted as reciting a processor.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 3-13, 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170014056 A1 (hereinafter referred to as “Newberry”).
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).
Regarding claim 3, Newberry 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).
Regarding claim 4, Newberry 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); 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.
Regarding claim 5, Newberry teaches wherein a wavelength of the second light is greater than a wavelength of the first light (uses both visible and IR light to detector glucose concentration; paragraphs [0158]-[0161]).
Regarding claim 6, Newberry 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 (uses both visible and IR light to detector glucose concentration (IR penetrates deeper into tissue than visible light); paragraphs [0158]-[0161]).
Regarding claim 7, Newberry 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 (IR penetrates deeper into tissue than visible light and emitting light will necessarily cause scattering within the tissue); paragraphs [0158]-[0161]).
Regarding claim 8, Newberry 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]).
Regarding claim 9, Newberry teaches wherein the determining the glucose value includes applying one or more conversion factors to the detected intensities (paragraphs [0161]-[0174]).
Regarding claim 10, Newberry 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 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]).
Regarding claim 12, Newberry 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]).
Regarding claim 13, Newberry 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 (paragraphs [0158]-[0161]); 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]).
Regarding claim 15, Newberry 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]).
Regarding claim 16, Newberry teaches wherein the processing unit is further configured to provide the glucose value for display by a display device (paragraphs [0083]-[0084]).
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).
Regarding claim 18, Newberry 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 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 (IR penetrates deeper into tissue than visible light and emitting light will necessarily cause scattering within the tissue); paragraphs [0158]-[0161]).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newberry as applied to claim 1 above, and further in view of US 20200085326 A1 (hereinafter referred to as “Fransen”).
Regarding claim 2, Newberry does not explicitly teach 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, 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.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newberry as applied to claim 1 above, and further in view of US 20040162470 A1 (hereinafter referred to as “Tu”).
Regarding claim 14, Newberry 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, 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) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable by Newberry in view of Fransen
Regarding claim 20, Newberry teaches a sensor device configured to be worn at an ear of a user (abstract) comprising:
at least one light source (2322 and 2314; paragraphs [0158]-[0161]; Figure 23) 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 (paragraphs [0158]-[0161] ); and
at least one detector (2330 and 2332; paragraphs [0158]-[0161]; Figure 23) 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 for determining (paragraphs [0158]-[0161]), based on the intensities of the first light and the second light, a glucose value representative of a glucose concentration within the tissue (paragraphs [0158]-[0161]).
Newberry does not explicitly teach a hearing device having
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, Fransen, a hearing instrument with detector capabilities, teaches a hearing device comprising: 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABID A MUSTANSIR whose telephone number is (408)918-7647. The examiner can normally be reached M-F 10 am to 6 pm Pacific Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ABID A MUSTANSIR/Examiner, Art Unit 3791