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 .
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract exceeds 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1 and 9 are objected to because of the following informalities:
Claim 1 recites “device worn” in line 1, but should read “device configured to be worn”
Claim 1 recites “a user’s body” in line 1, but should read “a body of a user”
Claim 1 recites “plurality of user’s bio signals” in line 2, but should read “plurality of bio signals of the user”
Claim 1 recites “signal of a user” in line 4, but should read “signal of the user”
Claim 9 recites “device worn” in line 1, but should read “device configured to be worn”
Claim 9 recites “a user’s body” in line 1, but should read “a body of a user”
Claim 9 recites “signal of a user” in line 3, but should read “signal of the user”
Appropriate correction is required.
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 1-15 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 1 recites “a controller configured to calculate the first bio signal of the user from the second optical signal” in lines 15-16. It is unclear as to how the first bio signal can be calculated by the controller when it has already been recited that the first bio signal is measured by the first biosensor in line 4 of Claim 1. Clarification is requested.
Claim 6 recites “a partial area of the first substrate” in line 4. It is unclear as to whether this limitation is referring to the previously introduced “a partial area between the first substrate and the second substrate”, or a separate element. Clarification is requested.
Claim 9 recites “a controller configured to calculate the first bio signal of the user from the second optical signal” in lines 14-15. It is unclear as to how the first bio signal can be calculated by the controller when it has already been recited that the first bio signal is measured by the first biosensor in line 3 of Claim 9. Clarification is requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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.
Claims 1-15 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).
Claims 1 and 9 recite “an interaction of the first optical signal with the user's body” in lines 13 and 12, respectively, which may imply that the user’s body is being positively recited as part of the claimed invention. For examination purposes, the claim is construed as being intended for use in the manner claimed, rather than the user's body being construed as part of the invention itself. The dependent claims inherit but fail to remedy the deficiencies of the independent claims.
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.
Claims 1-5, 8-13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Merritt et al (WO 2022/064273; cited by Applicant).
Regarding Claim 1, Merritt discloses a wearable electronic device worn on a user's body to face the user's body in a first direction (an improved optical sensing module is provided that is suitable for wearable devices; [0033-0036]) and configured to measure a plurality of user's bio signals ([0051]), the wearable electronic device comprising:
a first biosensor configured to measure a first bio signal of a user (optical sensing module; [0175-0176]; Figure 27);
a first substrate (“Substrate”; Figure 27) including a second biosensor configured to measure a second bio signal of the user (It is important to understand that any two or more of the embodiments disclosed could be combined in order to result in an optical sensing module with multiple functions. In one or more embodiments, the optical sensing module is configured to carry out one or more of, or all of • non-invasive temperature measurement; core body temperature measurement (e.g. by inclusion of a temperature prediction algorithm which may be included on an ASIC of the module)…stimulated Raman measurements (e.g. by implementation of pump and probe lasers within the plurality of lasers); [0191]; “PD N”; Figure 27); and
a second substrate disposed in a second direction being opposite to the first direction with respect to the first substrate (“BOX”; Figure 27),
wherein the first biosensor includes:
a light transmitter disposed on the second substrate and configured to transmit a first optical signal with respect to the user's body (transmitter PIC 1901; Figure 27);
a light receiver disposed on the first substrate and configured to receive a second optical signal generated through an interaction of the first optical signal with the user's body (“PD 1”; Figure 27); and
a controller (ASIC or microcontroller; [0177]) configured to calculate the first bio signal of the user from the second optical signal received by the light receiver ([0051]; SPO2; [0191]).
Regarding Claim 2, Merritt discloses wherein the first biosensor is a non-invasive glucose measurement sensor ([0051]).
Regarding Claim 3, Merritt discloses wherein the first optical signal includes a laser light, and the light transmitter includes a mid-infrared variable wavelength laser light source (a spectroscopy chip is capable of varying the specification of the interrogating light to adapt to the analytical chemistry of the material being analyzed. Some related art systems have complex receivers and have relatively low signal to noise ratio (SNR). A SiPh chip providing interrogating light may not have full wavelength scanning capability but may be capable of providing a range of interrogating wavelengths with high wavelength precision to yield spectroscopic data sufficient for the intended analysis - for example, glucose in blood in the medically important range with required precision and accuracy…the light sources are edge-emitting lasers; [0185-0189]).
Regarding Claim 4, Merritt discloses wherein the light transmitter comprises a photonic integrated circuit (An optical sensing module 1 for a wearable device is shown in FIGs. 1 A, IB and 1C. The optical sensing module 1 includes a transmitter photonic integrated circuit (PIC) 4; [0175]).
Regarding Claim 5, Merritt discloses wherein the light transmitter comprises a reflecting optical system disposed on the second substrate and configured to reflect the first optical signal being emitted from the photonic integrated circuit in a direction toward a body surface of the user ([0179-0180]; “reflecting mirror 2715”; Figure 27).
Regarding Claim 8, Merritt discloses at least one interposer disposed between the first substrate and the second substrate, and configured to electrically connect the light receiver and the controller to each other (The receiver includes collection optics such as a lens to pick up reflected light from the skin. A taper such as a buried interposer taper (see e.g. US10643903) may be present to convert input light from a larger input waveguide 5152 to a smaller sized waveguide platform; [0326]).
Regarding Claim 9, Merritt discloses a biosensor module of a wearable electronic device worn on a user's body to face the user's body in a first direction (an improved optical sensing module is provided that is suitable for wearable devices; [0033-0036]), the biosensor module comprising:
a first biosensor configured to measure a first bio signal of a user (optical sensing module; [0175-0176]; Figure 27);
a first substrate (“Substrate”; Figure 27) including a second biosensor configured to measure a second bio signal of the user (It is important to understand that any two or more of the embodiments disclosed could be combined in order to result in an optical sensing module with multiple functions. In one or more embodiments, the optical sensing module is configured to carry out one or more of, or all of • non-invasive temperature measurement; core body temperature measurement (e.g. by inclusion of a temperature prediction algorithm which may be included on an ASIC of the module)…stimulated Raman measurements (e.g. by implementation of pump and probe lasers within the plurality of lasers); [0191]; “PD N”; Figure 27); and
a second substrate disposed in a second direction being opposite to the first direction with respect to the first substrate (“BOX”; Figure 27),
wherein the first biosensor includes:
a light transmitter disposed on the second substrate and configured to transmit a first optical signal with respect to the user's body (transmitter PIC 1901; Figure 27);
a light receiver disposed on the first substrate and configured to receive a second optical signal generated through an interaction of the first optical signal with the user's body (“PD 1”; Figure 27); and
a controller (ASIC or microcontroller; [0177]) configured to calculate the first bio signal of the user from the second optical signal received by the light receiver ([0051]; SPO2; [0191]).
Regarding Claim 10, Merritt discloses wherein the first biosensor is a non-invasive glucose measurement sensor ([0051]).
Regarding Claim 11, Merritt discloses wherein the first optical signal includes a laser light, and the light transmitter includes a mid-infrared variable wavelength laser light source (a spectroscopy chip is capable of varying the specification of the interrogating light to adapt to the analytical chemistry of the material being analyzed. Some related art systems have complex receivers and have relatively low signal to noise ratio (SNR). A SiPh chip providing interrogating light may not have full wavelength scanning capability but may be capable of providing a range of interrogating wavelengths with high wavelength precision to yield spectroscopic data sufficient for the intended analysis - for example, glucose in blood in the medically important range with required precision and accuracy…the light sources are edge-emitting lasers; [0185-0189]).
Regarding Claim 12, Merritt discloses wherein the light transmitter comprises a photonic integrated circuit (An optical sensing module 1 for a wearable device is shown in FIGs. 1A, 1B and 1C. The optical sensing module 1 includes a transmitter photonic integrated circuit (PIC) 4; [0175]).
Regarding Claim 13, Merritt discloses wherein the light transmitter comprises a reflecting optical system disposed on the second substrate and configured to reflect the first optical signal being emitted from the photonic integrated circuit in a direction toward a body surface of the user ([0179-0180]; “reflecting mirror 2715”; Figure 27).
Regarding Claim 15, Merritt discloses at least one interposer disposed between the first substrate and the second substrate, and configured to electrically connect the light receiver and the controller to each other (The receiver includes collection optics such as a lens to pick up reflected light from the skin. A taper such as a buried interposer taper (see e.g. US10643903) may be present to convert input light from a larger input waveguide 5152 to a smaller sized waveguide platform; [0326]).
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.
Claims 6-7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Merritt et al in view of Eguchi et al (U.S. Publication No. 2016/0058339).
Regarding Claim 6, Merritt discloses a buffer member disposed in at least a partial area between the first substrate and the second substrate (“Si Substrate”; Figure 27; Examiner’s Note: The “Si Substrate” is equivalent to the buffer member as it is between the “Substrate”, equivalent to the first substrate, and the “BOX”, equivalent to the second substrate).
Merritt fails to specifically disclose wherein the first substrate comprises an opening formed to pass the first optical signal therethrough in a partial area of the first substrate.
In a similar technical field, Eguchi teaches a biological information acquisition device and electronic device (Abstract), wherein the first substrate comprises an opening formed to pass the first optical signal therethrough in a partial area of the first substrate (The light blocking film 133 is provided with openings (pinholes) 132 at positions corresponding to the positions at which the light transmissive portions 112 of the light emitting portion 110 are disposed; [0066]; Figure 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the opening teachings of Eguchi into the invention of Merritt in order to ensure that only the reflected light is passed through the openings is guided to light receiving elements and the rest of the reflected light RL is blocked by the light blocking film (Eguchi [0066]).
Regarding Claims 7 and 14, although Merritt teaches shutters ([0201]), Merritt fails to specifically teach a shielding member disposed between the light receiver and the second biosensor on the first substrate.
In a similar technical field, Eguchi teaches a biological information acquisition device and electronic device (Abstract), comprising a shielding member disposed between the light receiver and the second biosensor on the first substrate (light blocking portion 130; [0066-0067]; Figure 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the light blocking teachings of Eguchi into the invention of Merritt in order to ensure that only the reflected light is passed through the openings is guided to light receiving elements and the rest of the reflected light RL is blocked by the light blocking film (Eguchi [0066]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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