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 .
Response to Arguments
Applicant’s arguments with respect to claims 1-8, 11, 13-17, 21 have been considered but are moot in view of new ground of rejections.
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, 7-8, 11, 13-14, 16-17 rejected under 35 U.S.C. 103 as being unpatentable over Kwon [US 20170000350 A1], in view of Duong [US 20120106191 A1].
As per claim 1, Kwon teaches a wearable photoplethysmography system (wearable PPG system) configured to be placed at a target location of a user (Kwon ¶0029, ¶0033, Fig 1),
the wearable PPG system comprising:
a wearable device configured engage a body portion of the user (Kwon Fig 1, ¶00119);
an emitter configured to emit photons having a wavelength of at least 590 nanometers (Kwon Fig 1, items LL10, LL20, emitting wavelengths L10 and L20. ¶0146 “…the first incident light L10 and the first optical signal L10′ may fall within a wavelength range corresponding to any one of regions of red R, green G, blue B, and infrared IR light. The second incident light L20 and the second optical signal L20′ may fall within a wavelength range corresponding to another of the regions of red R, green G, blue B, and infrared IR light.” Red and Infrared have wavelengths greater than 590 nm);
a photodiode (Kwon Fig 11 PD1 and PD2).
wherein, when the wearable PPG system is placed at the target location of the user:
the wearable device disposes the emitter exit angle range, the arterial bed being between 0.6 millimeters and 5 millimeters from an external surface of the skin of the user (In view of applicant spec ¶0221, a radial artery of the user, is such a location. Kwon Fig 24, ¶0077, implies the arterial bed is in claimed range),
and at least a portion of the photons emitted by the emitter penetrates a tissue of the user, interacts with the arterial bed, and is then redirected to and detected by the photodiode (Kwon ¶0123 “the biological signal may be a photoplethysmogram (PPG) or other signal”, ¶0242 “The PPG signal may be measured by using the principle that an optical signal that is reflected or scattered varies according to a change in the volume of blood existing in a blood vessel BV2 of the subject SBJ.”)
Embodiment of Fig 1 in Kwon does not expressly teach
Embodiment of Fig 5 in Kwon teaches the at least one lens is configured an exit angle range between 30 and 90 degrees, the exit angle range being defined relative to a surface plane of the wearable PPG system (Kwon Fig 5, ¶0121 “the first light emission angle θ1 may be about 60° to 180°, and the second light emission angle θ2 may be about 0° to 100°. Alternatively, the first light emission angle θ1 may be about 80° to 180°, and the second light emission angle θ2 may be about 0° to 90°. Alternatively, the first light emission angle θ1 may be about 100° to 170°, and the second light emission angle θ2 may be about 5° to 50°.” These include the claimed exit angles).
Kwon discusses in ¶0244 that one of ordinary skill in the art to which the present inventive concept pertains would understand that the apparatuses and systems for detecting biological information and the methods of detecting biological information described with reference to FIGS. 1 to 59 may be changed in various ways, and that various changes in form and details may be made therein without departing from the spirit and scope as defined by the following claims. 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 of Fig 1 by integrating lenses as in Fig 5. The motivation would-be to secure optimal illumination intensity and an optimal light irradiation area for measurement of optimal biological signal (Kwon ¶0134).
Kwon does not expressly teach a lens cavity adjacent to the emitter; and at least one lens disposed within the lens cavity; the at least one lens is configured within the lens cavity relative to the emitter such that at least 75% of the photons emitted by the emitter.
Duong, in a field of optics for homogenizing light teaches, a lens cavity adjacent to the emitter (Duong Fig 7, ¶0069 lens cavity 188); and at least one lens disposed within the lens cavity (Duong Fig 7, ¶0069 item 114, ¶0069 “The ends of cavity walls 182 are spaced so that lens 114 can rest with surface 158 of lens 114”, ¶0076 “Homogenizer 120 transitions into lens 112, which extends from surface 151 to the exit face 152 of the optical element 125” lenses 112, 114); the at least one lens is configured within the lens cavity relative to the emitter such that at least 75% of the photons emitted by the emitter (Duong ¶0052-¶0053).
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 Kwon, by integrating homogenizer and multi-element optical stacking as discussed in Duong. The motivation would be to control the spatial homogenization of light projected towards a plane (Duong ¶0008).
As per claim 7, Kwon in view of Duong further teaches wherein the lens directs more than 90% of the photons within the exit angle range (Duong ¶0052).
As per claim 8, Kwon in view of Duong further teaches wherein the lens cavity comprises one or more reflective surfaces configured to reflect at least 50% of a plurality of photons that contact the one or more reflective surfaces (Duong ¶0042 “The cavity can be defined by or lined with a reflective material, such as TiO.sub.2 and can have a variety of shapes”. ¶0055 “a high percentage of the light emitted from optical device 121 is in that beam angle (e.g., greater than 70%, 75%, 80%, 85%, 90%, 95% or 98% of light in beam).”).
As per claim 11, Kwon in view of Duong further teaches further comprising one or more detector cavities in which the photodiode is disposed (Kwon Fig 1, this space is inherent when diode is placed in the device).
As per claim 13, Kwon in view of Duong further teaches wherein an input face of the lens that abuts the emitter is curved or disposed at a transverse angle relative to a surface plane of a housing of the PPG system, the curve and/or transverse angle of the input face being configured to increase a percentage of photons that exit the lens within the exit angle range (Kwon ¶0128 lens structure to condense or disperse light, implies some curvatures).
As per claim 14, Kwon in view of Duong further teaches wherein the surface plane of the wearable PPG system is defined by a housing of the wearable PPG system, and the exit surface of the lens protrudes beyond the surface plane such that, when the wearable PPG system is placed at the target location, the exit surface of the lens contacts the external surface of the skin of the user (Kwon ¶0143 “when a photoplethysmogram (PPG) signal is detected, rather than a surface pulse wave, a contact measurement method may be employed”, implies contact of lenses with skin in Fig 5 for ppg measurements).
As per claim 16, Kwon in view of Duong further teaches wherein the emitter is a light emitting diode (¶0138 “The light emission portion LT10 used in the present exemplary embodiment may include an LED”)
As per claim 17, Kwon in view of Duong does not expressly teach wherein the emitter is a vertical cavity surface emitting laser. However as per applicant spec, ¶0214 “Both types of emitters 2404 are capable of emitting photons with a wavelength of at least 590 nanometers, which is suitable for penetrating human tissue”. Specification notes that they are equally useful with respect to current invention without the VCSEL having any specific advantage. The specification does not set forth evidence that a VCSEL is critical, and of both statistical and practical significance. Hence it is an obvious modification or substitution to achieve same result of generating red / infrared lights.
Claims 2-6, 21 rejected under 35 U.S.C. 103 as being unpatentable over Kwon in view of Duong as applied to claim 1 above, and further in view of Glenn [US 20230130889 A1].
As per claims 2, 21, Kwon in view of Duong does not expressly teach wherein the target location is an ear of the user to target a posterior auricular artery of the user.
Glenn in a related filed of ppg monitoring teaches wherein the target location is an ear of the user to target a posterior auricular artery of the user (Glenn ¶0021 “the PPG sensor can be positioned at a concha-facing position or an anti-tragus-facing location for accessing the posterior auricular artery”).
Kwon mentions monitoring form other parts of body such as a finger, a toe, an earlobe, etc., having a high blood vessel density in a human body (Kwon ¶0162). Glen shows ppg monitoring using a shell having a uniquely-shaped outer surface that corresponds uniquely to an ear geometry of a wearer of the device. 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 Kwon in view of Duong by integrating features for ear wearing as in Glenn so as to provide sustained contact with skin for ppg monitoring from the ear, as suggested in Kwon.
As per claims 3-6, Kwon in view of Duong and Glenn further teaches wherein the arterial bed comprises a branch of the posterior auricular artery, wherein the branch emerges at an anterior face of the user's ear within seven (7) millimeters of a helical root of the user's ear, wherein, when the wearable PPG system is placed at the target location, the exit surface of the lens is less than 5 millimeters from a branch of the posterior auricular artery that perforates an auricular cartilage to protrude at an anterior face of the ear of the user, or wherein the branch protrudes from a base of a helical root of the ear of the user, and the exit surface is positioned at the base of the helical root (Glenn ¶0021 “concha-facing position or an anti-tragus-facing location for accessing the posterior auricular artery.” Fromm applicant Fig 17, spec. ¶0146-¶0147, these area substantially corresponds to branches from posterior auricular artery, where the sensor would be placed in the ear, e.g. 1712 or 1714 of applicant Fig 17).
Claim 15 rejected under 35 U.S.C. 103 as being unpatentable over Kwon in view of Duong as applied to claim 1 above, and further in view of Haisley [US 20130158372 A1].
As per claim 15, Kwon in view of Duong does not expressly teach wherein the lens comprises an elastomeric material having a Shore A durometer hardness of less than Shore 70A.
Haisley, in a related field of medical sensors, teaches wherein the lens comprises an elastomeric material having a Shore A durometer hardness of less than Shore 70A (Haisley ¶0071 “e emitter lens 180 and the detector lens 182 may have a hardness on the Shore OO durometer scale of less than approximately 60 …” this corresponds to 20 on a shore A scale) .
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 Kwon in view of Duong by integrating lenses with hardness features as in Haisley. The motivation would be to provide lens that is flush with the skin while providing less discomfort (Haisley ¶0071-¶0072).
Allowable Subject Matter
Claims 9-10 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.
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.
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.
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/Oommen Jacob/ Primary Examiner, Art Unit 3797