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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original non-provisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of a continuation or divisional application cannot include anything which would constitute new matter if inserted in the prior-filed application (MPEP 211.05.B).
The disclosure of the prior-filed application 17/494908 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The features not supported include, the unitary strap including the sensors as recited in claim 1, and discussed with respect to new drawings 16A, 16B, etc. The instant application is therefore awarded the priority of the earliest filed application, in this case the provisional of the instant application, of which there is adequate support, that being 08/31/2022.
If the applicant traverses the priority date, applicant is asked to particularly point out where the support for the claimed subject matter is disclosed in the priority documents.
Response to Arguments
Applicant's arguments filed 07/16/2025 have been fully considered but they are not persuasive.
Applicant argues on pages 5-6:
“Klaassen fails to teach or suggest a sensor located on top and the lateral side. According to Klaassen, “…2) positioned and oriented to interface with a subject's wrist upon [bottom] which the wrist-worn device 50 is worn, and 3) operatively connected with the main unit 52. The second drive current electrode 60 and the second sense electrode 62 are: 1) supported on the wrist-worn elongate band, 2) positioned and oriented to be interfaceable with the subject [Top] so that the drive current travels through the thoracic cavity of the subject (e.g., with separate fingers on the arm opposite to the arm on which the wrist-worn device 50 is worn), and 3) operatively connected with the main unit 52.” (Klaassen, Col. 15: 45-60)”
It is noted that examiner applied a US publication with reference to paragraph numbers (and not columns as referenced by the applicant), in relation to Fig 5. It is submitted that the discussion is directed to Fig 5 and related paragraph ¶0104-¶0106. Examiner respectfully disagrees for the following reasons. Firstly, as noted in Office Action, Fig 5 is a side view of the device. Examiners position is that the sensors 60, 62, in FIG 5, are placed in such a way that it covers at least a part of both top and side sides, in comparison to sensors 60, 62 in Fig 4, which can be arguably be said to be exclusively on top. There is a clear distinction in the two side views and the sensor placement. Thus, the sensors 60, 62 is on top and lateral side in same manner as sensors 308 and 309 of the applicant specification and meets the claimed features in light of the applicant spec.. Secondly, portions of spec. cited by applicant does not explain how or why a sensor, if not located on the lateral side, could be seen on a lateral or side view. It is clear from Fig 5, that the sensors are part of top/ lateral or bottom/ lateral. There is nothing additional in the claim that defines structure of the band, or the sensors that differentiates from structure and sensor placement of Fig 5 of Klaassen. Thirdly, “positioned and oriented to interface with a subject's wrist upon [bottom] which the wrist-worn device 50 is worn” does not meant that the electrodes 60, 62 cannot be partly on the lateral side. This simply means some part of bottom strap is facing skin, and as can be inferred from figure.
Applicant argues on page 6:
“Klaassen further emphasizes “In the illustrated embodiment, the first drive current electrode 56 is disposed on a directly opposite inside surface of the wrist-worn band 54 relative to the second drive current electrode 60 such that contact pressure between, for example, a finger of the subject and the second drive current electrode 60 transfers compression through the wrist-worn band 54 to the first drive current electrode 56, thereby increasing contact pressure between the first drive current electrode 56 and the wrist 72.” (Klaassen, Fig. 5, Col. 16: 7-15).
The wrist-worn device of Klaassen either has an electrode on the top part or the bottom part, but not the lateral side as claimed. The top part is where a user’s opposite fingers can touch and the bottom part where the user’s wrist is in contact with the band. There is simply no reading of Klaassen that teaches or suggests a sensor on the lateral side as claimed. In fact, the Klaassen device is designed to have the electrode on the top because it allows the use to transfer pressure to the electrodes located on the bottom and in contact with the user’s wrist. Accordingly, Klaassen fails to teach or suggest all the elements as claimed by Applicant. Accordingly, Applicant respectfully requests withdrawal of the rejections based on obviousness. ”
Examiner respectfully disagrees for same reasons as above. These arguments do not overcome the fact that the electrodes 60, 62 can be seen on the lateral view. As noted above, a component may be located or designed to have different sides, while only making contact with one surface. Examiner notes that the only way a single sensor (broad interpretation of “first of the plurality of electrical contact sensors”, and “second of the plurality of electrical contact sensors”) can be both on the top and lateral side is to have a configuration similar to as shown in Klaassen, and as described / shown in applicant Fig 4A.
Applicant’s arguments, with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections has been withdrawn.
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 1-2, 6-14 rejected under 35 U.S.C. 103 as being unpatentable over Klaassen [US 20170340209 A1] in view of Balajadia [US 20180353137 A1].
As per claim 1, Klaassen teaches a wearable device for measuring personal health (Klaassen Figs 5-6) comprising:
a unitary strap having a top outward facing face, a first and second lateral side, and a bottom side, wherein the bottom side faces a user's skin (Klaassen Fig 5, the four sides are implied for band 54. The bottom side is the inner side facing the wrist) ;
a plurality of electrical contact sensors (Klaassen Fig 5 item 60,62), wherein a first of the plurality of electrical contact sensors is located on the top face and the first lateral side (Klaassen Fig 5 side view is shown. Item 60 is on side and top face, as can be inferred in comparison to Fig 4, where 60 is shown to be fully on the top face), and a second of the plurality of electrical contact sensors is located on the top and the second lateral side of the wearable device (Klaassen Fig 5 side view is shown. Item 62 is on opposite lateral side and top face, as can be inferred in relation to Fig 4, where 62 is fully on the top face),
wherein the first and second electrical contact sensors are configured to complete a circuit therebetween when a user contacts the first sensor with a first surface of the user's skin and contacts the second sensor with the first or a second surface of the user's skin (Klaassen ¶0106 “The second drive current electrode 60 is contacted by the right index finger of the subject. The second sense electrode 62 is contacted by the right thumb of the subject.”, see Fig 6 for equivalent impedance circuits created upon contact), and
wherein the wearable device detects a PPG wave therewith (Klaassen ¶0103 “The main unit 52 includes circuitry and/or software for .. processing signals from the PPG sensor 64 and the first and second sense electrodes 58, 62 so as to measure a PTT and calculate one or more blood pressure values for the subject based on the PTT”);
a processor configured to generate and display biometric data on an interface screen (Klaassen Fig 7 items 82, 86, ¶0111).
Klaassen further mentions capability of device for communication to a second electronic device or database, cloud, phone or tablet (See for e.g. ¶0028). This implies a network communication module configured to transmit (Klaassen Fig 7 item 88, ¶0159 “the output may be communicated to a separate wearable device … communications port, memory, and inputs/outputs,”).
Klaassen does not expressly teach transmitting the detected PPG wave to a server, wherein the server processes the PPG wave and infers therefrom biometric data based on machine learned correlations generated from a training set of PPG waves and biometric data.
Balajadia, in a similar field of technology teaches transmitting the detected PPG wave to a server (Balajadia ¶0032 “A PPG wave is received by an analytical server from the device 100, step 702”), wherein the server processes the PPG wave and infers therefrom biometric data based on machine learned correlations generated from a training set of PPG waves and biometric data (Balajadia ¶0006 “the server processing the PPG wave to infer biometric statistics based on machine learned correlations generated from a training set of PPG waves and biometric data,”. see ¶0032-¶0036 for details for how this is performed in Fig 7).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Klaassen by utilizing transmission and processing of PPG signals in a server as in Balajadia. A processing at an external server is not limited by the functionality of the wearable device. The server has access to different or more processing, machine learning and statistical analytic capabilities. This would be to provide in depth more in-depth profile of patients health, and provide relative analysis based on correlations for understanding health details discussed in Balajadia ¶0005. This would be the motivation for the modification.
As per claim 2, Klaassen in view of Balajadia further teaches an output device configured to display at least one pattern associated with a status of the wearable device (Balajadia Fig 8 status of device, like time , battery, etc... is displayed on top).
As per claim 6, Klaassen in view of Balajadia further teaches wherein the server processes the PPG wave and infers therefrom biometric statistics and wherein the biometric statistics comprise at least one of overall health, changes in health, mood, sleep quality, fatigue, and stress (Balajadia ¶0008).
As per claim 7, Klaassen in view of Balajadia further teaches wherein the machine learned correlations are based on PPG character vectors including a Kaiser-Teager power energy value, heart rate value, and spectral entropy value (Balajadia ¶0008).
As per claim 8, Klaassen in view of Balajadia further teaches wherein the PPG waves are generated by infra-red, green, or red lights emitted from the personal healthcare device (Klaassen ¶0019 “The at least one PPG sensor may comprise at least one infra-red, red, or green optical source”).
As per claim 9, Klaassen in view of Balajadia further teaches wherein the personal health care device further comprises: an inline sensor (IS) comprising a first Near Field Infrared (NIR) Light Emitting Diode (LED), a second NIR LED, and a photodiode with wavelength sensitivity range between about 900 nm to about 1700 nm+10%, the photodiode located on the IS between the first and second NIR LEDs and configured relative thereto to receive reflected light from the first and second NIR LEDs, and a first and second angular mirror, each configured to reflect light from either of the first and second NIR LEDs onto a user's skin and for the user's skin to reflect light back to the photodiode, wherein the personal healthcare device generates the detected PPG wave based on the light reflected off of the user's skin (Balajadia Fig 6A, ¶0026).
As per claims 10, 12, Klaassen in view of Balajadia further teaches wherein the first NIR LED has a first wavelength in the near infrared spectrum and the second NIR LED has a second wavelength in the near infrared spectrum, or wherein the first NIR LED has a wavelength of about 1550 nm+10% and the second NIR LED has a wavelength of about 1300 nm+10% (Balajadia ¶0026 “1 Near Field Infrared (NIR) LED with Wave length of 1300 nano meter (nm) (606), 1 NIR LED with Wave length of 1550 nm (602)”).
As per claim 11, Klaassen in view of Balajadia further teaches wherein a first intermediate detected PPG wave is generated from light reflected off of the user's skin from the first NIR LED and a second intermediate detected PPG wave is generated from light reflected off of the user's skin from the second NIR LED, and the detected PPG wave is generated from the combination of the first and second intermediate detected PPG waves (Balajadia Fig 6, combination of lights are received at 604).
As per claims 13, 14 Klaassen in view of Balajadia further teaches wherein light from the first NIR LED is directed to the user's skin via the first angular mirror, and light from the second NIR LED is directed to the user's skin via the second angular mirror, such that the light from the first NIR LED is reflected back off of blood glucose molecules to the photodiode at a first predetermined angle and light from the second NIR LED is reflected back off of blood glucose molecules to the photodiode at a second predetermined angle, wherein the first predetermined angle is about 45 degrees and the second predetermined angle is about 90 degrees. (Balajadia Fig 6A, ¶0026).
Claim 3 rejected under 35 U.S.C. 103 as being unpatentable over Klaassen in view of Balajadia as applied to claim 2 above, and further in view of Ng [US 20070152977 A1].
As per claim 3, Klaassen in view of Balajadia does not expressly teach wherein the output device is a circular LED and wherein the device further comprises an input button bounded by the circular LED.
Ng teaches wherein the output device is a circular LED and wherein the device further comprises an input button within the circular LED (Ng Fig 8A, 8B items 260, 268).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Klaassen in view of Balajadia by integrating an illuminated touch pad as in Ng. The motivation would be to visual feedback system configured to illuminate the input surface in association with a user input (Ng ¶0015).
Claim 16 rejected under 35 U.S.C. 103 as being unpatentable over Klaassen in view of Balajadia as applied to claim 9 above, and further in view of Hall [US 20180092602 A1].
As per claim 16, Klaassen in view of Balajadia does not teach wherein the inline sensor is covered with a glass configured to direct light from either of the first and second NIR LEDs onto a user's skin and receive reflected light from the first and second NIR LEDs at the photodiode.
Hall, in a similar field of PPG sensors, teaches utilizing glass for PPG sensor (Hall ¶0040 “Cover glass 612 provides a smooth flat transparent surface for a user's thigh 624 to rest on while also providing protection to the PPG sensor array’)
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Klaassen in view of Balajadia by utilizing glass for smooth surface as well as protection (Hall ¶0040).
Allowable Subject Matter
Claims 4-5, 15 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The references made of record are considered pertinent to the claimed features. However, examiner does not find it obvious to modify references of record to show all limitations as recited in these claims.
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 OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/ Primary Examiner, Art Unit 3797
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