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 .
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on 8/5/2026 is acknowledged.
Claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/5/2026.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in French Republic on Dec-5 2023. It is noted, however, that applicant has not filed a certified copy of the FR2313608 application as required by 37 CFR 1.55.
Specification
All reference to the paragraph numbers in the instant specification made in this office action refer to the PG-Pub version of the document (US 2025/0176842)
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 6, 12, 13, 15, 17, & 20 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.
Claim 6 recites “device of claim 1, wherein the physiological end sensor is positioned” in lines 1-1. Claim one recites both a first and second physiologic end sensor, and it is unclear whether “the physiological end sensor” in claim 6 refers to the first, the second, or both. For examination purpose this claim is interpreted as “at least one of the physiologic end sensors is positioned”.
Claim 12, 13, & 15 recites the limitations “the first physiological finger sensor” and "the second physiological finger sensor" in lines 1-2. There is insufficient antecedent basis for these limitations in the claim. The examiner notes that this would be resolved by depending claims 12, 13, & 15 on claim 10.
Claim 17 recites “the physical interface being positioned between the second edge, respectively the first edge, and half, or even a third, of a length of the housing along the direction of extension from the second edge, respectively the first edge” in line 3-5. It is unclear what is meant by “between the second edge, respectively the first edge” and “what is meant by half, or even a third, of a length of the housing along the direction of extension from the second edge, respectively the first edge.” For examination purposes this limitation is interpreted as “positioned between the first and second edges, and at least half or at least a third of the length L from the first or second edge in the extension direction.”
Claim 20 recites “measuring the physiological end sensor by the user in a one-handed handling position” in line 2. It is unclear what is doing the measuring. For the purpose of examination this limitation is interpreted as “measuring with the physiological end sensor by the user in a one-handed handling position.”
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.
(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.
A rejection on this statutory basis (35 U.S.C. 102(g) as in force on March 15, 2013) is appropriate in an application or patent that is examined under the first to file provisions of the AIA if it also contains or contained at any time (1) a claim to an invention having an effective filing date as defined in 35 U.S.C. 100(i) that is before March 16, 2013 or (2) a specific reference under 35 U.S.C. 120, 121, or 365(c) to any patent or application that contains or contained at any time such a claim.
Claims 1, 2, 6, 9, & 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banet et al. (US 2017/0188859 hererinafter Banet '859).
Regarding claim 1, Banet '859 teaches a portable physiological measurement device holdable by a user (Fig. 1-5 and “handheld device featuring an integrated form factor that fits in a patient's hand and measures all vital signs and some hemodynamic parameters from the human body” in [0026]), comprising: a housing (177 in Fig. 4 and “a housing of the handheld device” in [0064] and see annotated figure below) of elongated shape (106 in Fig 1 and “the extended neck 106” in [0064]) along an extension direction and comprising, along the extension direction, a first end defining a first edge (138 in Fig. 3 and “an upper, outer, forward-facing “nose” portion 138” in [0071]) and a second end defining a second edge (104 in Fig. 3 and “C-shaped, wrist-receiving portion 104” in [0073]), a first physiological end sensor positioned at the first end (136 in Fig. 3 & 4 and “the infrared temperature sensor 136” in [0071]) and comprising a functional surface intended to be positioned facing a user (to measure TEMP, the handheld device 100 is held close to the patient's ear so that the outer portion 138 is adjacent to or pressed up against either the left or right ear” in [0071]), the functional surface being inscribed in the edge at the end, a second physiological end sensor positioned at the second end (150A, 150B in Fig. 3-5 “the wrist-contacting electrodes 150A, 150B” in [0079]), and a physiological finger sensor (132 and 134 in Fig. 3 & 4) arranged on the housing near the first end or the second end (“A second, finger-receiving cavity portion 105 located at an opposite end of the device has an opening which is configured and positioned to receive the distal end of the patient's thumb… The cavity portion 105 houses an optical system—part of the pulse oximetry subsystem of the device” in [0063] see annotated Fig. 1 and 4) wherein the second end defines a second edge and the second physiological sensor comprises a functional surface (150A & 150B in Fig. 3-5 and “the electrodes 150A, 150B are formed from a stretchable, conductive fabric that is stretched over the inflatable bladders” in [0081]) inscribed in the second edge, wherein the physiological end sensor is positioned within a volume defined by the housing or at most 1 mm outside the volume defined by the housing (136 in Fig.s 3 & 4, and “the temperature sensor 136 is a fully digital system, meaning it receives the infrared radiation with an internal photodetector” in [0071]), wherein the finger sensor comprises an optical sensor (134 in Fig.s 3 & 4 and “optics (LED 132, photodetector 134) within the finger-receiving cavity portion” in [0089]), (132 and 134 in Fig.s 3 & 4 and “the cavity portion 105 houses an optical system—part of the pulse oximetry subsystem of the device” in [0063]).
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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 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Banet '859 in view of Vajdic et al. (WO 2020/232040 hereinafter Vajdic).
With regard to claim 4-5, Banet ‘859 teaches the portable physiological measurement device of claim 1
Banet ‘859 does not teach wherein a distance along the extension direction between the first end and the second end is of length L, and wherein a distance that separates the physiological finger sensor from the first end or the second end is less than half the length L and wherein the distance that separates the physiological finger sensor from the first end or the second end is less than a quarter of the length L.
However, attention is drawn to the Vajdic reference. Vadjic discloses compact, hand-held ECG devices for recording and analyzing a patient’s ECG without using cables. The apparatus may include two electrodes for contacting the patient’s chest and two electrodes for contacting the patient’s fingers. The finger electrodes may be integrated at the front and/or sides of the device [0008]. The device records 3 orthogonal lead cardiac signals when held against the user's chest ([0009]). The apparatus includes two recording chest electrodes disposed on pivotable and/or retractable arms hinged at the casing of the device (0045]). These arms are located in compartments (22 & 30 in Fig. 1) symmetrically located along the longitudinal line of the device (the extension direction between the first end and the second end is of length L), adjacent to the shorter edge ([0049]). The hand or finger electrodes may be located on either the side of front face of the casing (14 in Fig. 1 and 705 & 707 in Fig. 7), so that the fingers can be positioned on these electrodes while holding the apparatus against the patient’s chest, which advantageously enables the patient to get a good grip on the device and to hold it securely for recording an ECG ([0016]).
Vadjic explains that in order to prevent wrong positioning of the device, according one embodiment, the hand electrodes 14 are offset relative to the transverse centerline of the front face 12 in order to provide asymmetric electrode configuration (see annotated Fig. 1 and Fig. 7). Namely, during the recording, the side of the front face 12 where the hand electrodes 14 are disposed is oriented towards patient’s head. In this way, the upper and lower side of the device can be easily distinguished by the patient ([0064]). Since the electrodes of offset from the transverse centerline, they are necessarily less than half of the distance L from one of the end (wherein a distance that separates the physiological finger sensor from the first end or the second end is less than half the length L).
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Vadjic does not explicitly disclose the degree of offset from the centerline. However, Vadjic does disclose that the position of the finger electrodes is a results effective variable that impacts a patients ability to get a good grip on the device and to hold it securely against their chest for recording an ECG, and facilitates correct positioning by indicating an upper and lower side of the device that can be easily distinguished by the patient. The specification of instant application does not disclose any criticality or unexpected result from the placement of the finger sensor at less than a quarter of L rather than less than half of L. Therefore, wherein a distance that separates the physiological finger sensor from the first end or the second end is less than a quarter of the length L is understood to be routine optimization.
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to position the finger sensor such that a distance that separates the physiological finger sensor from the first end or the second end is less than half the length L and less than a quarter of the length L as taught by Vadjic to the handheld device taught by Banet ‘859 for the purpose of enabling the patient to get a good grip on the device.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Banet '859 in view of Tanaka (US 2021/0330192).
With regard to claim 7, Banet ‘859 teaches the portable physiological measurement device of claim 1 and wherein the physiological end sensor is a temperature sensor (136 in Fig. 3 & 4 and “the temperature sensor 136” in [0071]).
Banet ‘859 does not teach wherein the functional surface comprises a cone.
However, attention is drawn to the Tanaka reference. Tanaka teaches an infrared ear thermometer and a holder for an ear thermometer ([0002] that measures body temperature by detecting infrared emissions from the eardrum. Tanaka teaches a thermometer with a hollow conical base portion (Fig. 1-2 12a) and a cylindrical tip (Fig. 1-2 12b, [0055]). This configuration can be stably held in an ear hole so that that the infrared emitted from an eardrum rays can be efficiently received by the infrared sensor [0057].
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to apply the conical shape taught by Tanaka to the temperature sensor taught by Banet ‘859 to allow the infrared emitted from an eardrum rays can be efficiently received by the infrared sensor of the temperature sensor.
Claims 8 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Banet '859 in view of Ali et al. (US Patent No. US 6584336, hereinafter Ali).
With regard to claim 8 & 18, Banet ‘859 teaches the portable physiological measurement device of claim 1
Banet ‘859 does not teach further comprising a display, wherein: in a one-handed handling position for the first end sensor, the display is configured to display information along a reading direction transverse to the extension direction, in a two-handed handling position in which the finger sensor is used, the display is configured to display information along a reading direction parallel to the extension direction and comprising a display and comprising a gyrometer and/an accelerometer configured to determine the orientation in space of the device and to adapt the reading direction of the display as a function of this orientation.
However, attention is drawn to the Ali reference. Ali teaches a transportable pulse oximeter that can stay with and continuously monitor the patient as they are transported from setting to setting (col. 3, line 23-25). The pulse oximeter is configured to function in both a first spatial orientation and a second spatial orientation with a tilt sensor providing an output responsive to gravity (a gyrometer and/an accelerometer configured to determine the orientation in space of the device and to adapt the reading direction of the display as a function of this orientation). It also includes a display with a first mode and a second mode that shows the measurement value in the first mode when the apparatus is in the first orientation and shows the measurement value in the second mode when the apparatus is in the second orientation (col. 4, lines 46-62). The display is a dot matrix LCD device having 160 pixels by 480 pixels. The display can be shown in portrait mode (in a one-handed handling position for the first end sensor, the display is configured to display information along a reading direction transverse to the extension direction), illustrated in FIG. 8B, or in landscape mode (in a two-handed handling position in which the finger sensor is used, the display is configured to display information along a reading direction parallel to the extension direction), illustrated in FIG. 8C. A tilt sensor (FIG. 9) in the docking station 660 (FIG. 6) or a display mode key on the portable 610 (FIG. 6) determines portrait or landscape mode (Fig. 8B and 8C and col. 11, line 61-66). This allows the instrument to be operated in either a vertical or horizontal orientation including "upside-down" portrait or "upside-down" landscape orientations.
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to apply a display with a transverse and longitudinal display mode controlled by a gyrometer taught by Ali to the handheld device taught by Banet ‘859 for the purpose of allowing the instrument to be operated in either a vertical or horizontal orientation.
Claims 10-14 & 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Banet '859 in view of Banet & Zhao (US 2006/0009698, hereinafter Banet '698).
With regard to claims 10-14 Banet ‘859 teaches the portable physiological measurement device of claim 1
Banet ‘859 does not teach wherein the physiological finger sensor is a first physiological finger sensor arranged near the first end and the device further comprises a second physiological finger sensor, arranged on the housing near the second end, wherein each physiological finger sensor comprises an electrode, wherein the first physiological finger sensor and the second physiological finger sensor are aligned parallel to the extension direction, comprising a physical interface arranged on the housing and the second physiological finger sensor is positioned on the physical interface and wherein the housing comprises an essentially parallelepiped shape with a front face and a top face arranged between the first end and the second end, the front face and the top face being connected.
However, attention is drawn to the Banet '698 reference. Banet '698 teaches a monitor for measuring blood pressure and other vital signs from a patient without using a cuff ([0006]). In embodiments, both the first and second sensors are disposed on the first surface, e.g. the monitor's front surface. In this case, for example, the patient makes a measurement by holding the monitor so that a finger from one hand contacts the first sensor, and a finger from the other hand contacts the second sensor (Fig. 1 and and [0007]) (wherein the physiological finger sensor is a first physiological finger sensor arranged near the first end and the device further comprises a second physiological finger sensor, arranged on the housing near the second end). These pad sensors (4 in Fig. 1 and shown in detail in Fig. 3) include both an optical sensor and an electrode (28 in Fig. 3) shaped as an annular ring that, when coupled with a reference electrode (29 in Fig. 3), generates a time-resolved electrical signal ([0020]) (wherein each physiological finger sensor comprises an electrode). This combination of electrode and optical sensor allows the device to correlate the electrical impulse from the patient’s heart with the optically measured pulse wave, and calculate the ΔT between them, giving an additional criteria for use in determining blood pressure. As can be seen in Fig. 1, the electrodes on the front face are aligned parallel to an extension direction of the monitor (wherein the first physiological finger sensor and the second physiological finger sensor are aligned parallel to the extension direction).
The patient views information from a liquid crystal display (LCD) display 3 and can interact with the monitor (1 in Fig. 1) (e.g., reset or reprogram it) using a series of buttons (6a, 6b, & 6c in Fig. 1) ([0021]). These buttons control functions within the monitor such as a manual measurement switch 6a, on/off switch 6b, and a system reset 6c ([0028]). The patient can initiate a measurement through the user interface on the front surface, and after a short delay presses a finger from the other hand against the second sensor on the front surface to complete the measurement ([0007)] (comprising a physical interface arranged on the housing and the second physiological finger sensor is positioned on the physical interface).
In [0068] the instant specification clarifies that “by “essentially parallelepiped shape,” it is meant that the device approximates a rectangular prism, with sides that are predominantly flat or slightly curved to facilitate ergonomic handling. This definition allows for minor variations, such as rounded edges or corners, to enhance user comfort and safety during manipulation, provided these variations do not significantly alter the overall geometric resemblance to a parallelepiped. Such adjustments are consistent with the device's design intent for portability and ease of use.” The device depicted in Fig. 1A&B reads on this limitation in light of the specification (wherein the housing comprises an essentially parallelepiped shape with a front face and a top face arranged between the first end and the second end, the front face and the top face being connected).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to incorporate two electrode finger sensors on a parallelepiped surface aligned in a parallel direction with a display and interface on a front face as taught by Banet '698 to the handheld device taught by Banet ‘859 for the purpose of allowing the device to measure and correlate both optical and electrical signals, and allow the patient to activate the device then quickly place their finger on the sensor.
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With regard to claim 16 and 17 Banet ‘859 in view of Banet '698 teaches the portable physiological measurement device of claim 14, as laid out above.
Banet ‘859 does not teach comprising a display, the display being located on the front face and comprising a physical interface positioned on the front face, the physical interface being positioned between the second edge, respectively the first edge, and half, or even a third, of a length of the housing along the direction of extension from the second edge, respectively the first edge.
However attention is drawn to Banet ‘698. As explained above, Banet ‘698 teaches that the patient views information from a liquid crystal display (LCD) display 3 (a display, the display being located on the front face), and can interact with the monitor (1 in Fig. 1) (e.g., reset or reprogram it) using a series of buttons (6a, 6b, & 6c in Fig. 1) ([0021]). These buttons control functions within the monitor such as a manual measurement switch 6a, on/off switch 6b, and a system reset 6c ([0028]). The patient can initiate a measurement through the user interface on the front surface, and after a short delay presses a finger from the other hand against the second sensor on the front surface to complete the measurement ([0007)] (comprising a physical interface arranged on the housing and the second physiological finger sensor is positioned on the physical interface). In figure 8B an alternative embodiment is shown in which the interface is at least half of the length of the extension direction from one edge relative to the opposing edge. In this embodiment, the patient initiates a measurement with a pair of buttons 210, 211 on the monitor's front surface 200b ([0033]) (the physical interface being positioned between the second edge, respectively the first edge, and half, or even a third, of a length of the housing along the direction of extension from the second edge, respectively the first edge).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to incorporate a physical interface on a front face and a display as taught by Banet '698 to the handheld device taught by Banet ‘859 for the purpose of allowing the patient to view information from the display, and allow the patient to activate the device then quickly place their finger on the sensor.
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Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Banet '859 in view of Geva et al. (US 2017/0027521, hereinafter Geva).
With regard to claims 14-15 & 20, Banet ‘859 teaches the portable physiological measurement device of claim 1, and a one handed method of using the device of claim 1 (“to measure TEMP, the handheld device 100 is held close to the patient's ear so that the outer portion 138 is adjacent to or pressed up against either the left or right ear. Because the temperature sensor is positioned where it is, the patient can take a temperature reading with the same device used to measure the other physiological parameters, and without even having to remove the device from his or her hand to do so” in [0071])
Banet ‘859 does not teach wherein the housing comprises an essentially parallelepiped shape with a front face and a top face arranged between the first end and the second end, the front face and the top face being connected, and measuring with the finger physiological sensor by the user in a two-handed handling position.
However, attention is drawn to the Geva reference. Geva teaches a system for monitoring vital signs configured to be used in conjunction with a computerized mobile device ([0004]) such as a “cellphone” or “smartphone”, a personal digital assistant, or a handheld computer ([0047]). that includes a plurality of the physiological sensors ([0012]) designed to be used with a mobile device. The system include a cover suitable to cover or encase, at least partially, mobile device. The cover may include a front side, a backside, and a sidewall body portion extending from the edge of the front side to the edge of the cover's backside. As seen in Fig. 1B&C this constitutes an essentially parallelepiped shape with a front face and a top face arranged between the first end and the second end, the front face and the top face being connected.
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Geva goes on to disclose physiological sensors (1110A-1110E FIGS. 1B and 1C), can be included in or constitute a part of the backside of cover, while sensors (1110Fa and 1110F FIGS. 2A and 2B) may be included in or constitute a part of the front side of cover 1105. Furthermore, physiological and/or validation sensors 1110 and/or 1120 may be included in and/or constitute a part of the cover's sidewall like. e.g., sensor 1110G ([0051]). Some of these sensors may detect ECG signals when “a finger of one of the user's two hands may be in contact with the electrode of a first physiological sensor 1110B, while the finger of the user's other hand may be in contact with the electrode of a second physiological sensor 1110C, and a third finger of either one of the user's hands may be set to be in contact with the electrode of a third physiological sensor 1110D at the same time, for example, to generate contact in approximate accordance with the so-called “Eindhoven triangle” ([0075]) (measuring with the finger physiological sensor by the user in a two-handed handling position). Although the exemplary embodiments depicted in Fig.s 1B & 1C show the finger sensors located on the front side of the cover (analogous to the front face of the instant application), Geva teaches that any of these sensors could be positioned on the sidewall (analogous to the top face of the instant application) as shown in the positions of sensor 1111G and 1120B2 in Fig. 1C([0051]) (wherein the first physiological finger sensor and the second physiological finger sensor are positioned on the top face).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to position physiologic finger sensors on an essentially parallelepiped shaped device as taught by Geva to the handheld device taught by Banet ‘859 for the purpose of to be used in conjunction with a computerized mobile device and positioning the sensors for no more than the predictable result of allowing a patient to place multiple fingers on the device while using a handheld device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM P ADAMS whose telephone number is (571)270-0136. The examiner can normally be reached 9am-6pm M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571)272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.P.A./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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