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 § 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.
Claims 1-20, specifically claim 1, is rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea, judicial exemption, without significantly more. Please see the below 2 step, prong analysis:
Step 1:
Claim 1 is directed to a system, which is a statutory category of invention.
Step 2A, prong 1:
Claim 1 recites limitations that are directed to an abstract idea.
Claim 1 recites method steps directed to:
…a display configured to prompt the user…to cause the imager to capture an image…and to display the image captured by the imager…
…a controller configured to determine…whether the second hand wearing the annular biosensor is at a height…to control the biological data measurement system to obtain the biological data based on the determining of whether the second hand wearing the annular biosensor is at a height of the user
These limitations, under their broadest reasonable interpretation, fall within the mental processes grouping of abstract ideas. It would be practical, but for the recitation “a display” and “a controller” to perform the steps in a human's mind, or with pen and paper, to utilize the image and/or biological data.
Step 2A, Prong 2:
The claims as a whole fails to integrate the abstract idea into a practical application. Claim 1 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application.
“…a body having an annular shape/a sensor…configured to measure biological data…” which is directed to data gathering, see MPEP 2106.05(g).
“…a light emitter…configured to emit lit, which is directed to data gathering, see MPEP 2106.05(g).
“…a mobile control unit configured to communicate with the biosensor…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…an imager configured to capture images…” which is directed to data gathering, see MPEP 2106.05(g).
“…a display configured to prompt the user…to capture…and to display the image…” which is directed to data output, see MPEP 2106.05(g).
“…a controller configured to determine…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
Therefore, the claims fail to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited in claim 1 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The claim is silent to providing any treatment at all to a patient.
Step 2B:
The claims as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
real-time discrete data obtained from a medical device/data previously collected from a medical device (i.e. body surface/unipolar electrodes) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
producing at said computer processor a human-readable output (i.e. processor) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea”.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
Therefore, claim 1 fails to recite significantly more than the abstract idea and claims 9-28 are rejected under 35 U.S.C 101.
Regarding the dependent claims, i.e. claims 2-20, the limitations define steps of recognizing a position of the annular biosensor in the image, graphically display and/or utilize biological data,
which further limit claim limitations already indicated above as being directed to an abstract idea. Therefore, claims 2-20 are directed to patient-ineligible subject matter.
AND
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In regards to claim 1, the claim limitation “…a light emitter disposed in the body…” positively recites the human body, which is considered non-statutory subject matter. It is suggested to use language such as “adapted for,” “configured to,” etc.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zemel (US 2020/0196881).
Zemel discloses;
1.
A biological data measurement system comprising: an annular biosensor including:
a body having an annular shape and that is configured to be worn on a finger or a wrist of a user, and
a sensor disposed in the body and configured to measure biological data including a blood pressure of the user;
E.G. via the disclosed watch 504 having an PPG sensor 320 and pressure sensor 324 on the sensor 108, wherein the sensor 108 is coupled to the processor 300 of the mobile device 100 {[0064], [0106] & (Fig 12)}.
and a light emitter disposed in the body and configured to emit light in a predetermined patten;
E.G. via the disclosed PPG sensor array 528 comprising multiple light emitting diodes (LEDs) 512 and multiple photodetectors 508 {[0110] & (Fig 14a)}.
and a mobile control unit configured to communicate with the biosensor and including:
an imager configured to capture images,
E.G. via the disclosed computer processor 300/500 of the mobile device 100 that is configured to communicate the measured values of the PPG sensor 320 and the pressure sensor 324 to the computer processor 300/500 [0064], wherein the mobile device further includes a camera built in [0128].
a display configured to prompt the user holding the mobile control unit in a first hand to cause the imager to capture an image of a face of the user and a second hand that is wearing the annular biosensor and to display the image captured by the imager,
E.G. via the disclosed display 104 of the watch 504, in which the camera records an image of the face 604 while the mobile device is known to be a particular anatomical location of interest, i.e. heart level 600 {[0061], [0128] & (Figs 12 & 18A-D)}.
and a controller configured to detect, in the image, the predetermined pattern of light emitted by the light emitter and configured to recognize a position of the annular biosensor in the image based on the detected pattern
E.G. via the disclosed computer 500 of the measurement system and display, which utilizes a PPG sensor array 528 and light emitting diodes 512, creating a ‘PPG image’ to locate a target artery to measure blood volume oscillations, in which the surface of said PPG array is designed to facilitate positioning of the anatomy of interest ([0110]-[0111]), wherein said display may further provide the user with real-time feedback regarding the location of the anatomical location of interest in respect to said sensor ([0074] & [102]).
and determine, based on the image, whether the second hand wearing the annular biosensor is at a height of a chest of the user, and also to control the biological data measurement system to obtain the biological data based on the determining of whether the second hand wearing the annular biosensor is at the height of the chest of the user.
E.G. via the disclosed computer 500 and display 104 of the watch 504, in which the camera records an image of the face 604 while the mobile device is known to be a particular anatomical location of interest, i.e. heart level 600 {[0061], [0106], [0128] & (Figs 12 & 18A-D)}.
2.
The biological data measurement system according to claim 1, wherein: a surface of the body of the annular biosensor comprises an identification marking that includes at least one of a letter, a symbol, a one-dimensional code, and a two-dimensional code, the identification mark recognizable in the image captured by the imager of the mobile control unit, and
the controller is configured to recognize a position of the annular biosensor in the image by recognizing the identification marking.
E.G. via the disclosed use of the sensor having a data acquisition system which provides a visual display that guides the user in performing the actuation against the anatomy of interest, wherein the display may further provide the user with real-time feedback regarding the location of the anatomical location of interest in respect to said sensor ([0074] & [102]).
Note: The examiner is interpreting the data acquisition system that guides the display and the sensor as being the claimed identification marking including a ‘letter, a symbol, a one-dimensional code, and a two-dimensional code, which is recognizable in the image captured by the imager of the mobile control unit.’
3.
The biological data measurement system according to claim 1, wherein: the body of the annular biosensor has a shape that is recognizable in the image,
E.G. [0100].
and the controller is configured to recognize a position of the annular biosensor in the image by recognizing the shape of the body in the image.
E.G. via the disclosed visual feedback provided of the sensor 108 via the display 104.
4.
The biological data measurement system according to claim 1, wherein: a surface of the body of the annular biosensor includes a light state variable component configured to reflect, scatter, or absorbs light,
E.G. via the disclosed sensor 108 including a PPG sensor 320 in the form of an infrared, reflectance-mode PPG sensor [0081].
And the controller is configured to recognize a position of the annular biosensor in the image by recognizing the light state variable component in the image.
E.G. via the disclosed mobile device 100 being able to determine the anatomical positioning of the sensor [0080].
5.
The biological data measurement system according to claim 3, wherein: the mobile control unit includes a unit-side light emitter configured to emit light in a predetermined pattern,
and the controller is configured to recognize the position of the annular biosensor in the image by recognizing the annular biosensor reflecting or scattering the light emitted in the predetermined pattern in the image.
E.G. via the disclosed PPG sensor 320 further including a LED and photodetector ([0080]-[0081]), specifically the photodetector 508 and the light emitting diode 512 [0107].
6.
The biological data measurement system according to claim 1, wherein: the light emitter is disposed on a sensor-side.
E.G. via the disclosed PPG sensor 320 further including a LED and photodetector ([0080]-[0081]), specifically the photodetector 508 and the light emitting diode 512 [0107].
7.
The biological data measurement system according to claim 6, wherein: the sensor of the annular biosensor is a photoplethysmographic sensor including a light-emitting element and a light-receiving element, the sensor-side light emitter is the light-emitting element of the photoplethysmographic sensor, and a directivity angle of the light-emitting element of the photoplethysmographic sensor is greater than a directivity angle of the light-receiving element of the photoplethysmographic sensor.
E.G. [0107].
8.
The biological data measurement system according to claim 1, wherein the controller is configured to recognize the face of the user in the image and to estimate a position of the chest of the user in the image based on a display position and a display size of the face.
E.G. via the disclosed position detection system that is built into the mobile device that may ensure the mobile device is being held at heart level, wherein the camera records the image of the face in order to determine the position [0128].
9.
The biological data measurement system according to claim 8, wherein the controller is configured to obtain prestored physical information of the user and to estimate the position of the chest of the user based at least partially on the prestored physical information.
E.G. via the disclosed camera comparing the current image of the face to the previously recorded image 604 known to the heart level [0128].
10.
The biological data measurement system according to claim 8, wherein the controller is configured to recognize the face of the user and the second hand wearing the annular biosensor in the image, to estimate a relative position between the mobile control unit and a trunk of the user based on a ratio between the display size of the face of the user and a display size of the second hand,
and to determine whether the relative position is within a predetermined range.
E.G. via the disclosed position detection system of the mobile device 100 that can help to determine if the sensor is above or below the heart level 600, most effective in the upright posture {[0128] & (Fig 18A-18D)}.
11.
The biological data measurement system according to claim 10, wherein: the mobile control unit includes an inclination sensor configured to detect an inclination of the mobile control unit with respect to a vertical direction,
and the controller is configured to determine whether an inclination of the trunk of the user with respect to the vertical direction and a lateral direction is within a predetermined range based on the inclination of the mobile control unit with respect to the vertical direction detected by the inclination sensor.
E.G. via the disclosed accelerometer that is part of the mobile device 100 that is used to confirm the heart level 600 {[0128]-[0129] & (Fig 12A-12B)}.
12.
The biological data measurement system according to claim 11, wherein the controller is configured to recognize the face of the user and the second hand wearing the annular biosensor in the image, to estimate the relative position between the mobile control unit and the trunk of the user based on the display size of the face of the user and the display size of the second hand,
and to determine whether the inclination of the trunk of the user with respect to the vertical direction and a forward-backward direction is within a predetermined range based on the inclination of the mobile control unit detected by the inclination sensor and the relative position between the mobile control unit and the trunk of the user.
E.G. {[0128]-[0129] & (Fig 12A-12B)}.
13.
The biological data measurement system according to claim 11, wherein the controller is configured to recognize the face of the user and the second hand wearing the annular biosensor in the image, to estimate the relative position between the mobile control unit and the trunk of the user based on the display size of the face of the user and the display size of the second hand, to determine whether the inclination of the trunk of the user with respect to the vertical direction is within a predetermined range based on a result of the estimation and the inclination of the mobile control unit detected by the inclination sensor, and to control the annular biosensor based on a result of the determination.
E.G. {[0128]-[0129] & (Fig 12A-12B)}.
14.
The biological data measurement system according to claim 1, wherein the display of the mobile control unit is configured to graphically display a recommended range of a display position of the face and a display size of the face.
E.G. via the disclosed display 104 that graphically displays for the mobile device ([0062] & [0074]).
15.
The biological data measurement system according to claim 14, wherein: the controller is configured to recognize the face of the user in the image,
and the display is configured to inform the user whether the display position of the face and the display size of the face are within the recommended range.
E.G. via the disclosed position detection system that is built into the mobile device that may ensure the mobile device is being held at heart level, wherein the camera records the image of the face in order to determine the position [0128].
16.
The biological data measurement system according to claim 11, wherein the display is configured to display information indicating whether the relative position between the mobile control unit and the trunk of the user and the inclination of the trunk of the user are within predetermined ranges.
E.G. via the disclosed accelerometer that is part of the mobile device 100 that is used to confirm the heart level 600 {[0128]-[0129] & (Fig 12A-12B)}.
17.
The biological data measurement system according to claim 11, wherein: the annular biosensor includes: a determiner configured to determine whether the annular biosensor is worn on the finger or the wrist of the user,
E.G. via the disclosed finger being the anatomical location of interest ([103]-[0108])
And a sensor-side communicator configured to transmit and receive data to and from the mobile control unit, the sensor-side communicator is further configured to transmit a result of determining whether the annular biosensor is worn on the finger or the wrist,
E.G. via the disclosed finger placement indicator 590 attached to the mobile device 100 [0125].
and the controller is configured to prevent a determination of the inclination of the trunk of the user when the annular biosensor is not worn on the finger or the wrist.
E.G. via the disclosed mobile device 100 position detection purposes recorded image via the sensors as compared to the heart level 600 [0128].
18.
The biological data measurement system according to claim 1, wherein the biological data further includes at least one of a blood sugar level, a pulse, breathing, a pulse wave, oxygen saturation, a body surface temperature, and an activity amount.
E.G. via the disclosed sensor 108 including a plurality of sensors such as a PPG sensor 320, a pressure sensor 324, and/or a temperature sensor 326 [0064].
19.
The biological data measurement system according to claim 11, wherein the controller is further configured to calculate a reliability level of the obtained biological data based on a result of determining the inclination of the trunk of the user with respect to the vertical direction.
E.G. via the disclosed algorithm that can output a confidence level one the accuracy of the measurement quality, wherein said measurements are used to determine if the mobile device 100 is positioned relative to the heart level, i.e. effective when the user is in the upright posture ([0118] & [0128]).
20.
The biological data measurement system according to claim 11, wherein the controller is configured to correct the biological data based on a result of determining the inclination of the trunk of the user with respect to the vertical direction.
E.G. via the disclosed mobile device 100 can adjust the measurements according to the height of measurement as compared to the heart level ([0128]-[0129]).
Response to Arguments
Applicant's arguments filed December 3, 2025 have been fully considered but they are not persuasive. The applicant argues the following points in which the examiner provides a reason as to why the arguments are not persuasive:
The applicant argues that the claim amendments submitted overcome the previous 35 U.S.C 101 claim rejections, wherein claims 1-20 were alleged to be directed to an abstract idea.
Based on the broadest reasonable interpretation the examiner disagrees and further points out that the claim amendment “…a light emitter…configured to emit light in a predetermined pattern...” and “…a controller configured to detect…the predetermined pattern of light emitted…and configured to recognize a position of the annular biosensor…” does not overcome the rejection under 35 U.S.C §101
Under Step 2A, Prong One, the claims remain directed to an abstract idea, namely collecting information, analyzing information and recognizing a position based on detected data, i.e. subject matter directed to abstract mental processes. Under Step 2A, Prong Two, the additional limitation of the ‘light emitter’ and ‘detect a pattern of light’ does not integrate the abstract idea into a practical application. The light emitter merely functions as a generic data acquisition component used to obtain information about the position of the sensor. The claim does not recite any specific technological improvement, nor does it describe a technical solution that improves the functioning of the device.
Accordingly, the claim remains directed to non-statutory subject matter under 35 U.S.C §101.
The applicant argues that the primary reference, Zemel, fails to disclose, suggest and/or teach the claimed invention since the reference is silent in regards to a light emitter disposed in the body and configured to emit light in a predetermined pattern and a controller configured to detect the predetermined pattern of light emitted…and configured to recognize a position of the annular biosensor in the image based on the detected pattern.
The examiner disagrees and further points out that Zemel discloses a PPG sensor array 528 comprising multiple light emitting diodes (LEDs) 512 and multiple photodetectors 508 {[0110] & (Fig 14a)}, which provides the claim light emitter configured to emit light in a predetermined pattern. Zemel also discloses a computer 500 of a measurement system and a display, which utilizes a PPG sensor array 528 and light emitting diodes 512, creating a ‘PPG image’ to locate a target artery to measure blood volume oscillations, in which the surface of said PPG array is designed to facilitate positioning of the anatomy of interest ([0110]-[0111]), wherein said display may further provide the user with real-time feedback regarding the location of the anatomical location of interest in respect to said sensor ([0074] & [102]).
Applicant’s arguments, filed December 3, 2025, with respect to the 35 U.S.C §112 claim rejections have been fully considered and are persuasive and have been withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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 NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796