DETAILED ACTION
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 1-12 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 1, the limitation “with a wearing fit detecting function” renders the claim indefinite. Such preamble phrasing is uncommon in US practice and function seems to imply some sort of method claim or possible functional language and is confusing. For purposes of examination the indefinite limitation has been deemed to claim that the monitoring device is capable of fit detection based on claimed structural components in the body of the claim.
Regarding Claim 1, the limitation “wherein each light-emitting element” and “wherein each light-receiving element” renders the claim indefinite. The claim previously introduces a single light-emitted element and light receiving element, however, the limitation “each” implies more than one light emitting and light receiving element. Therefore, the limitation “each” renders the claim indefinite, because the additional emitters are receivers have not been previously claimed.
Regarding Claim 1, the limitation “as a basis to determine a wearing fit” is grammatically confusing and ambiguous. It is unclear what is meant by such phrase, how the optical elements determine wearing fit. For purposes of examination the indefinite limitation has been deemed to claim that any light-emitting and light-receiving elements can be used as a “basis” to determine wearing fit.
Regarding Claim 1, the limitation “to block the blood glucose monitoring module and the optical feedback sensing module” renders the claim indefinite. Block from what? Each other? Block together from something else? For purposes of examination the indefinite limitation has been deemed to claim the block each from each other.
Regarding Claim 2, the limitation “correspondingly emits” renders the claim indefinite. It is unclear what limitation “correspondingly” imparts on the claims. For purposes of examination the indefinite limitation has been deemed to claim that the multi-chip LED is capable of emitting a plurality of light signals at specific wavelengths.
Regarding Claim 3, the limitation “the light-receiving element corresponds to a wavelength response range” is indefinite, because it is unclear what is meant by a element “corresponding” to a range of wavelengths. For purposes of examination the indefinite limitation has been deemed to claim that the light-receiving element is capable of detecting wavelengths.
Regarding Claim 5, the limitation “its” renders the claim indefinite, because it is not known what element “it” corresponds to. For purposes of examination the indefinite limitation has been deemed to claim that the distance is between two adjacent emitters/receivers.
Regarding Claim 6, the limitation “quantity” of each of the emitter and receiver renders the claim indefinite, and also causes the claim to lack proper antecedent basis, because only one emitter and receiver have been claimed, so it is unclear how there would be more or less of each. For purposes of examination the indefinite limitation has been deemed to claim at least one emitter and receiver.
Regarding Claim 7, the limitation “both plural” also renders the claim indefinite because only one emitter and receiver have been claimed. It is not understood how a single item can also be “plural”. For purposes of examination the indefinite limitation has been deemed to claim at least one emitter and receiver.
Regarding Claim 8, the limitation “which mainly adopts” renders the claim indefinite, because it is unclear what scope, size or limitation the processor “mainly” performs the claimed function. For purposes of examination the indefinite limitation has been deemed to claim that the processor is capable of analyzing reflected signals.
Regarding Claim 10, the limitation “each blocking structure” renders the claim indefinite, because only a single blocking structure has been previously claimed. For purposes of examination the indefinite limitation has been deemed to claim more than one blocking structure.
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.
Claim(s) 1-4 and 6-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20210290120 A1 to Al-Ali et al. (hereinafter, Al-Ali).
Regarding Claim 1, Al-Ali discloses a non-invasive blood glucose monitoring device (measurement module 400) with a wearing fit detection function, comprising inter alia:
a substrate, defining a first setting area (location of first group of emitters 404a and detectors 406a) and a second setting area (location of second group of emitters 404b and detectors 406b), wherein the second setting area is between an edge of the substrate and the first setting area (the location of emitters 404b and detectors 406b is located between emitters 404a/detectors 406b and an edge of measurement module 400 as best seen in FIG. 16B),
a blood glucose monitoring module, disposed in the first setting area (paragraph [0200] “..measurement sensor or module 100 configured to measure… glucose…”) (e.g., the emitters 404a and detectors 406a are configured to detector glucose),
an optical feedback sensing module, disposed in the second setting area and including at least one light-emitting element and at least one light-receiving element, wherein each light-emitting element emits a light signal corresponding to at least one specific wavelength and each light-receiving element receives the light signal corresponding to the at least one specific wavelength, after being reflected, as a basis to determine a wearing fit (paragraph [0200] “..measurement sensor or module 100 configured to measure… glucose…”) (e.g., the emitters 404b and detectors 406b are configured to detector other parameters), and
at least one light-blocking wall, disposed on the substrate and located between the first setting area and the second setting area to block the blood glucose monitoring module and the optical feedback sensing module (first and second light barriers 420 and 422).
Regarding Claim 2, Al-Ali discloses wherein each light-emitting element is a multi-chip LED which correspondingly emits a plurality of light signals of specific wavelengths (paragraph [0026] “The optical physiological sensor can comprise a plurality of emitters, the emitters configured to emit light of a plurality of different wavelengths, the plurality of different wavelengths comprising at least three different wavelengths…”).
Regarding Claim 3, Al-Ali discloses wherein the light-receiving element corresponds to a wavelength response range, and the plurality of specific wavelengths fall within the wavelength response range (paragraph [0026] “…a plurality of detectors, the detectors configured to detect light emitted by the plurality of emitters and attenuated by tissue of the user when the watch is worn on the wrist of the wearer and output signals to a sensor processor for determining the physiological parameters of the wearer…”).
Regarding Claim 4, Al-Ali discloses wherein the wavelength response range is between 500 nm and 1100 nm (paragraph [0252] “The first wavelength can be from about 525 nm to about 650 nm, or from about 580 nm to about 585 nm, or from about 645 nm to about 650 nm, or about 525 nm, or about 580 nm, or about 645 nm. The light providing the reference signal can have an orange or yellow color. Alternatively, the light providing the reference signal can have a green color.”).
Regarding Claim 6, Al-Ali discloses wherein a quantity of the at least one light-emitting element is not less than a quantity of the at least one light-receiving element (first group of emitters 404a and detectors 406a and second group of emitters 404b and detectors 406b).
Regarding Claim 7, Al-Ali discloses wherein when the at least one light-emitting element and the at least one light-receiving element are both plural, the light-emitting elements and the light-receiving elements are arranged symmetrically relative to the blood glucose monitoring module (see FIG. 16B).
Regarding Claim 8, Al-Ali discloses a processing unit, which mainly adopts photoplethysmography to analyze the reflected light signal corresponding to the at least one specific wavelength for determining the wearing fit (paragraph [0026] “…to a sensor processor for determining the physiological parameters of the wearer…”).
Regarding Claim 9, Al-Ali The non-invasive blood glucose monitoring device with the wearing fit detection function as claimed in claim 1, wherein the first setting area is located at a center of the substrate (the first group of emitters 404a and detectors 406a are located at a left center portion of the substrate), and the second setting area surrounds the first setting area (especially as broadly claimed, the second group of emitters 404b and detectors 406b technically “surrounds” a side portion of the first group of emitters 404a and detectors 406a).
Regarding Claim 10, Al-Ali discloses wherein the optical feedback sensing module further includes at least one blocking structure, wherein each blocking structure is disposed between any light-emitting element and its adjacent light-receiving element, and wherein each blocking structure extends from the edge of the substrate and connects to or approaches any light-blocking wall (first and second light barriers 420 and 422) (see FIG. 16B).
Regarding Claim 11, Al-Ali discloses a packaging structure, disposed on the substrate and adopted to package the blood glucose monitoring module and the optical feedback sensing module (PCB 116).
Regarding Claim 12, Al-Ali discloses the non-invasive blood glucose monitoring device with the wearing fit detection function as claimed in claim 11, further comprising a transparent cover, disposed on the packaging structure to protect the blood glucose monitoring module and the optical feedback sensing module (paragraph [0011] “The sensor can include a light barrier between emitters and detectors of the module and/or light diffusing materials …”) (paragraph [0079] “In some configurations, the light diffusing material can comprise glass microspheres.”).
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 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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali.
Al-Ali does not expressly disclose a center distance between each light-emitting element and its adjacent light-receiving element is between 1 mm and 4 mm. However, a skilled artisan would have been motivated to separate the emitters and receivers between 1-4mm, especially on a device ranging from 40-50mm in size (see paragraph [0217]), because this would have been one of many ranges between emitters/receivers a skilled artisan would chose to provide measurement signals. Such modification of distance between emitters and receivers is routine in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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