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 of group I, claims 1-4 and 10 in the reply filed on 09/15/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “wireless communication unit”, “user interface unit”, “sensor control unit”, “central control unit”, in claim 1. “EGG measuring unit”, “PPG measuring unit”, in claim 4, The mentioned limitations recite a “unit” without providing any structural details regarding what the unit includes.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
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.
Claim 1-4 and 10 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). Claim 1 recites “a wristband connected to the main body and wound around a wrist of a user” which positively recites the wrist of a user, i.e., human body. The claim should be amended to recite “configured to, designed to, etc., [] wound around a writs of a user”.
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2007319232A to Ouchi et al. (hereinafter “Ouchi”).
Regarding [Claim 1] (Original) Ouchi discloses a wearable device for measuring multiple biosignals (para 0029, “biological information measuring device 10”, fig. 2), comprising: a main body having one or more external ports (para 0044 “connector 110”, fig. 2); a wristband connected to the main body and wound around a wrist of a user (para 0028, 0045 “belt 101”, fig. 2); and one or more external sensors connected to the external ports (para 0045-0047, etc., “second pulse wave measurement unit 12”), wherein the main body includes: one or more built-in sensors configured to measure biosignals (para 0044 “first pulse wave measuring unit 11”; a wireless communication unit configured to transmit multiple biosignals obtained from the built-in sensors or the external sensors to an outside (para 0029 “a communication unit 23 for transmitting data stored in the data storage unit 19 to an external terminal”); a user interface unit configured to display a notification message instructing measurement of the multiple biosignals and receive user data (para 0028-0029 “display unit”); a sensor control unit configured to amplify an output signal of the built-in sensor and convert the amplified signal into a digital signal (para 0020, 0029-0032), detect whether the external sensor is connected to the external port, and when the external sensor is connected to the external port, disable the built-in sensor that measures the same biosignal as the external port (para 0029-0030, 0037, 0044, 0047 “switching unit 13 for selecting either the first pulse wave measurement unit 11 or the second pulse wave measurement unit 12 for pulse wave measurement”); and a central control unit configured to supply multi-biosignal data from the sensor control unit to the wireless communication unit (para 0029, 0032, control unit”) and transmit a notification message received from the wireless communication unit to a display of the user interface unit (para 0029).
Claim(s) 2-4 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouchi as applied to claim 1 above, and further in view of WO2016142793A1 to Aldo et al. (hereinafter “Aldo”).
Regarding [Claim 2] (Original) Ouchi discloses the wearable device of claim 1, wherein: the built-in sensors include a built-in accelerometer sensor; and the external sensor includes one or more of an external electrocardiogram patch, to which external EGG electrodes are connected, an external oxygen saturation sensor, an external blood pressure monitor, and an external body temperature sensor (para 0032 “acceleration measurement unit 16”, para 0029 second pulse wave measurement unit 12) but fails to disclose a built-in electrocardiogram (ECG) sensor, a built-in oxygen saturation sensor, a built-in respiratory rate sensor, a built-in gyro sensor, a built-in air pressure sensor, a built-in body temperature sensor, and a built-in temperature sensor.
Aldo, from a similar field of endeavor, teaches having a portable device having various internal sensors including ECG, EOG, EMG, temperature sensor, photoplethysmographic sensor, etc., to measure various physiological parameters of the person (Description). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Ouchi with the teachings of Aldo, to provide the predictable result of measuring various physiological parameters of the person.
Regarding [Claim 3] (Original) Ouchi as modified by Aldo renders obvious the wearable device of claim 2, wherein the main body includes: a rear surface that faces the wrist of the user while the wristband is wound around the wrist of the user and through which the built-in oxygen saturation sensor and a first electrode of the built-in EGG sensor are exposed (para 0028, 0041 “main body-integrated first pulse wave measurement unit 11 is installed on the lower surface side of the casing”); and a front surface at which the built-in body temperature sensor, a second electrode of the built-in ECG sensor, and the display of the user interface unit are exposed (para 0029, figs. 2, 5; Aldo’s various sensors).
Regarding [Claim 4] (Currently Amended) Ouchi as modified by Aldo renders obvious the wearable device of claim 2, wherein the sensor control unit is configured to: when the external EGG electrodes are connected to the external port, disable a built-in EGG measuring unit connected to the built-in EGG electrodes and enable an external EGG measuring unit to which the external EGG electrodes are connected (see rejection of claim 1, para 0029-0030, 0037, 0044, 0047 “switching unit 13 for selecting either the first pulse wave measurement unit 11 or the second pulse wave measurement unit 12 for pulse wave measurement”); and when the PPG sensor is connected to the external port, disable a built-in PPG measuring unit connected to the built-in PPG sensor and enable a built-in PPG measuring unit to which the external PPG sensor is connected (Aldo, Description, “photoplethysmographic sensor” “ When the external sensor 2-1 0 is connected, the operation of the internal sensor 2-1 is disabled.”).
Regarding [Claim 10] (New) Ouchi as modified by Aldo renders obvious the wearable device of claim 3, wherein the sensor control unit is configured to: when the external ECG electrodes are connected to the external port, disable a built-in ECG measuring unit connected to the built-in ECG electrodes and enable an external ECG measuring unit to which the external ECG electrodes are connected; and when the PPG sensor is connected to the external port, disable a built-in PPG measuring unit connected to the built-in PPG sensor and enable a built-in PPG measuring unit to which the external PPG sensor is connected (Aldo, Description, “photoplethysmographic sensor”, “electrocardiogram (ECG)”, “ When the external sensor 2-1 0 is connected, the operation of the internal sensor 2-1 is disabled.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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/SANA SAHAND/Examiner, Art Unit 3796
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