DETAILED ACTION
Claims 1-18 are pending and hereby under examination.
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 § 112
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 3 and 8 are 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 3, it is unclear how the dome “takes up the user’s forces”. Does the dome absorb the impact and not deform? Does the dome deform under the pressure, in the direction of the printed circuit board? Does the dome measure the forces? It appears Applicant intends to claim that the dome deforms towards the printed circuit board, which, in response, deforms the circuit board. For examination purposes, that is how the claim will be interpreted. However, Applicant should clarify the language of “takes up the user’s forces”.
Regarding claim 8, “the electrode” lacks antecedent basis. It appears Applicant intends for claim 8 to depend on claim 7, where “an electrode” is first recited. For examination purposes, that is how the claim will be interpreted.
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)(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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reynolds (US 20230200668).
Regarding claim 1, Reynolds teaches an optical assembly comprising:
an optical unit comprising an optical sensor (Fig. 14, optical chip),
a deformable printed circuit board (Fig. 14, PCB), the optical unit being physically mounted and electronically connected to the deformable printed circuit board (Fig. 14, optical chip on PCB), and
a force sensor configured to determine information relating to a deformation of the printed circuit board (Fig. 14, pressure sensor; Paragraph 0072, “A pressure sensor is disposed at the bottom of the assembly under the gel or bladder to sense an application of force by a user”).
Regarding claim 2, Reynolds further teaches wherein the optical unit comprises an interaction surface configured to be in contact with a user (Fig. 14, wherein the finger contacts the low viscosity gel; Paragraph 0073, “This cavity is filled in this implementation by an optically transparent gel and the user places their finger on the exposed upper surface of the gel, which then conforms to the shape of the user's finger to facilitate blood pressure measurement”).
Regarding claim 3, Reynolds further teaches wherein the optical unit comprises a dome which defines the interaction surface (Fig. 14, low viscosity gel), the dome being mounted on the printed circuit board so that the dome takes up the user's forces towards the printed circuit board (Fig. 14, optically transparent gel placed on PCB; Paragraph 0073, “This cavity is filled in this implementation by an optically transparent gel and the user places their finger on the exposed upper surface of the gel, which then conforms to the shape of the user's finger to facilitate blood pressure measurement”).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds (US 20230200668) as applied to claim 1, and in further view of Reynolds (US 20230200668).
Regarding claim 4, Reynolds teaches the assembly according to claim 1 above. Reynolds fails to explicitly define the pressure sensor as a piezoelectric deformation sensor. However, Reynolds discloses known pressure sensors, silicon piezoresistors, seen in Fig. 26, as an example (Paragraph 0086). As Reynolds discloses the pressure sensor seen in Figs. 12A-D and 14, Reynolds teaches other known pressure sensors, such as piezoresistors. The substitution of one known element for another would have yielded the predictable results of measuring pressure information to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Reynolds with the piezoresistor taught by Reynolds in a separate embodiment, yielding the predictable results of measuring pressure to one of ordinary skill in the art.
Regarding claims 7-8, Reynolds teaches the assembly according to claim 1 above. Reynolds further discloses, in an alternate embodiment, the assembly comprising an electrode with a contact surface configured to be in contact with a user, wherein the electrode is an ECG electrode (Paragraph 0101, wherein ECG signals can also be measured by using a sensor chip, wherein two electrodes are supplied to make contact to fingers on opposite hands of the subject). Reynolds discusses that an ECG is a valuable diagnostic tool, but, when paired with PPG, can improve the accuracy and reliability of BP prediction.
Reynolds further discloses, in an alternate embodiment, the optical unit being movable relative to the contact surface (See Fig. 19 below, wherein the bladder 1920 with electronics package disposed on the mount is compressed by the finger 1901. The bladder with the electronic package is movable compared to the contact surface).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Reynolds to incorporate an ECG electrode with the bladder/contact surface arrangement as taught by Reynolds, in a separate embodiment, the benefit in improving the accuracy and reliability of measurements.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds (US 20230200668) as applied to claim 1 above, and further in view of Shemesh (US 20210361237).
Regarding claims 5 and 6, Reynolds teaches the assembly according to claim 1 above. Reynolds further discloses the sensors on the same face of the PCB (Fig. 14). Reynolds fails to disclose the optical unit being mounted on the front face and the force sensor being mounted on the rear face, the sensors mounted substantially opposite from each other.
Reynolds and Shemesh are in the same field of blood pressure measurement. Shemesh teaches an alternate construction of a pressure sensor/optical sensor assembly. The sensor assembly comprises an optical unit (Fig. 1, light source 106 and detector 108; Paragraph 0073, the optical sensor being a PPG sensor) that is mounted to a flexible membrane 110, wherein a force sensor is mounted substantially opposite the optical PPG sensor on the flexible membrane 110 (Fig. 1A; Paragraph 0146, “The sensor assembly 100 further comprises a detection unit 109 mounted within the interior INT of the sensor assembly and configured to measure the displacement of the member 101 caused by the application of pressure to the contact surface 102 from the exterior of the sensor assembly”). As there are only a finite number of ways to arrange two sensors on a flexible support, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp with a reasonable expectation of success in measuring the pressure exerted on the pressure sensor while taking measurements with an optical sensor. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor assembly disclosed by Reynolds with the alternate construction of a sensor assembly taught by Shemesh, and one of ordinary skill in the art would have a reasonable expectation of success in measuring pressure and optical parameters.
Claims 9-18 are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds (US 20230200668).
Regarding claim 9, Reynolds further teaches a device comprising a housing (Fig. 14, package surrounding the gel, pressure sensor, optical chip, microcontroller, and PCB) and the optical assembly according to claim 1 (see rejection of claim 1 above). Reynolds further teaches the optical unit being movable (See Figs. 12C-D, wherein the pulse and oxygen sensors are moved when the gel is compressed by the finger, Fig. 12C depicting a rest position and Fig. 12D depicting a displaced position. Reynold fails to explicitly teach the optical unit being movable relative to the housing. However, Reynolds does disclose an embodiment with a housing (See Fig. 14, packaging; Fig. 13, upper housing 202 and lower housing 204; Fig. 25, mobile device 2550) and an embodiment with a moveable optical unit (Figs. 12C-D). As Reynolds discloses both the moveable optical unit and a sensor with a housing, one of ordinary skill would have been motivated in applying the movable optical sensor to the known housing, and the results of having an optical sensor residing within a housing would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Reynolds to incorporate the housing as taught by Reynolds in a separate embodiment, and the results of having an optical sensor residing within a housing would have been predictable to one of ordinary skill in the art.
Regarding claim 10, the combination of Reynolds discloses the device of claim 9 above. Reynolds further disclose wherein the optical unit comprises an interaction surface configured to be in contact with a user (Fig. 19), wherein at least the interacting surface of the optical unit protrudes from the housing in the rest position (Fig. 19, the bladder protruding out above the contact surface prior to the finger pressure being applied).
Regarding claim 11, the combination of Reynolds discloses the device of claim 9 above. Reynolds further discloses wherein the deformable printed circuit board is fixed at each of its ends to the housing (Fig. 14, the PCB attached to the housing package at both ends).
Regarding claim 12, the combination of Reynolds discloses the device of claim 9 above. Reynolds further discloses the printed circuit board is fixed to the ends of the housing (Fig. 14, the PCB attached to the housing package at both ends). In an alternate embodiment, Reynolds suggests the PC board can be held in place by one or more seal pins (See Fig. 59, seal pins 5927; Examiner interprets more than one seal pin as being a “clamp”).
Regarding claim 13, the combination of Reynolds discloses the device of claim 9 above. Reynolds further discloses wherein the housing has an elongated shape along an extension direction, wherein the deformable printed circuit board is attached to the housing at two opposite ends along the extension direction (Fig. 14, wherein the package is elongated from left to right, and the PCB is connected to the package at either end).
Regarding claim 14, the combination of Reynolds discloses the device of claim 9 above. Reynolds fails to explicitly disclose wherein the device is configured to provide a user with information representative of the force exerted on the optical unit in the displaced position. However, in an alternate embodiment, Reynolds discloses an alternative construction where the sensors are on a mobile device to sense the pressure (Paragraph 0085) and the phone display provides visual feedback to guide the finger actuation pressure (Paragraphs 0048-0049). Reynolds discusses feedback allows the user to apply the correct pressure, analogous to an inflating arm cuff. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Reynolds to incorporate the phone display, the benefit in giving the user visual feedback to apply the right pressure.
Regarding claim 15, the combination of Reynolds discloses the device of claim 9 above. Reynolds fails to explicitly disclose wherein the device is configured to provide a user with information representative of the force exerted on the optical unit in the displaced position. However, in an alternate embodiment, Reynolds discloses an alternative construction where the sensors are on a mobile device to sense the pressure (Paragraph 0085) and the phone display provides visual feedback to guide the finger actuation pressure (Paragraphs 0048-0049; Examiner interprets guiding “the finger actuation pressure” and guiding the user to “apply a pressure ramp that is analogous to an inflating arm cuff” as a pressure range, as applying too low or too high of a pressure would necessarily fall out of the “inflating arm cuff” range). Reynolds discusses feedback allows the user to apply the correct pressure, analogous to an inflating arm cuff. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Reynolds to incorporate the phone display, the benefit in giving the user visual feedback to apply the right pressure.
Regarding claim 16, the combination of Reynolds discloses the device of claim 9 above. Reynold further discloses wherein the optical sensor comprises a light source and a light receiver (Paragraph 0051, “An important component of the PPG measurement includes a light emitting diode (LED) and Photodiode Detector”), the device comprising an optical module configured to generate instructions enabling the light source to emit light and configured to receive signals from the light receiver (Paragraph 0051, “The LED sends light into the highly scattering tissue which interacts with the blood pulsing through the transverse palmar arch artery in the pad of the finger, in this example. The scattered light travels back to the skin surface where it is detected by a photodiode sensor”).
Regarding claim 17, the combination of Reynolds discloses the device of claim 16 above. Reynolds further discloses wherein the optical module is configured to determine a heart rate or a blood oxygen saturation of the user (Paragraph 0093, “ The oscillometric sensing is done by measuring the applied pressure with a force sensor and the pulse amplitude in the finger using a photoplethysmogram (PPG) sensor. This basic sensing architecture can be used to monitor more physiologic parameters than just blood pressure and heart rate”; Paragraph 0052, “In some implementations, the red wavelength can be used to compute blood oxygen saturation, provide added information for the algorithm to improve BP predictions and/or detect error conditions”).
Regarding claim 18, the combination of Reynolds discloses the device of claim 16 above. Reynolds further discloses wherein the device comprises a pressure module configured to calculate a blood pressure of the user on the basis of signals received by the optical module and the force sensor (Paragraph 0071, “As illustrated in FIG. 12B, a user's finger is depressed onto the structure of FIG. 12A causing the gel mass to deflect and conform to the surface of the user's finger. The LED and detector are then in intimate contact with the finger, facilitating measurement of the user's blood pressure”; Paragraph 0093, “In further accordance with the disclosure, three illustrative electronic architectures for the oscillometric fingertip blood pressure monitoring system are shown in FIGS. 38-40. The oscillometric sensing is done by measuring the applied pressure with a force sensor and the pulse amplitude in the finger using a photoplethysmogram (PPG) sensor”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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